Digital interventions have the potential to increase access to care. Despite their demonstrated efficacy in clinical trials, however, they often suffer from low sustained engagement in real-world contexts. Digital alliance (i.e., therapeutic alliance between user and app) may enhance engagement and outcomes, but its role in guided digital interventions (i.e., those with human support) is little understood.

Using data from two studies involving the mental health app mindLAMP, we examined digital alliance and its association with engagement and outcomes.

In Study 1, mindLAMP was offered as a standalone app with several brief check-ins by a digital navigator (aka coach). In Study 2, mindLAMP was integrated into a brief teletherapy program supported by a clinician and a digital navigator. Digital alliance was assessed near study midpoint with a validated measure.

Digital alliance was associated with engagement in both studies. In Study 1, digital alliance predicted subsequent app engagement, b = 0.18, p < .01, adjusting for prior engagement, which remained significant, b = 0.62, p < .001. Similarly, in Study 2, digital alliance predicted subsequent engagement, b = 0.21, p < .01, adjusting for prior engagement, b = 0.22, p < .05. Digital alliance also predicted co-morbid anxiety and depressive symptoms at post-intervention, after adjusting for baseline symptoms, in Study 1, b = -0.27, p < .001, but not in Study 2.

Participant demographics were not representative of the general population.

Findings underscore the potential of digital alliance in enhancing engagement and outcomes in digital interventions.

Digital mental health interventions (DMHIs) are effective in reducing symptoms of depression and anxiety. Low user engagement and uptake of DMHIs observed in previous research may be addressed by involving the intended target audience in the design of the DMHI from the outset.

This study is phase 1 of a multiphase project aimed at designing, developing, and evaluating a blended DMHI for depression and anxiety in Australia. Our objective was to partner with adults with lived and living experiences of depression and anxiety on their needs and expectations of a new transdiagnostic DMHI for depression and anxiety. This included identifying strategies that would help increase their engagement with the DMHI and their preferences for integrating the DMHI with psychotherapy.

A mixed methods participatory design approach was used to collect quantitative and qualitative data via a web-based survey (n=324) and semistructured interviews (n=21). Feedback was collected on participants' needs and expectations for the DMHI, including accessibility, content, features, functionality, format, data sharing, preferred clinical support pathways, and barriers to and facilitators of user engagement. Qualitative interview data were analyzed using reflexive thematic analysis.

Most participants (190/257, 73.9%) preferred a DMHI delivered as a smartphone app that could be used at any time of the day. Ease of use and a well-designed interface were important, as was a positive, encouraging, and uplifting DMHI look and feel. Other preferences included symptom tracking, diverse therapeutic content, and features that facilitated social connection and peer support (eg, online community and stories of lived and living experience). Participants also suggested several strategies to enhance engagement with the DMHI, including personalization, reminders, short and achievable activities, and goal setting. Participants reported a strong interest in sharing information from their DMHI with mental health professionals (to facilitate therapy), especially regarding changes to their emotions.

Transdiagnostic DMHIs for depression and anxiety have great potential to improve access to affordable, evidence-based mental health support. Involving people with lived and living experiences of depression and anxiety in the design, development, and conceptualization of DMHIs may improve uptake, acceptance, engagement, usability, and ultimately, treatment outcomes.

Portable digital electronic devices have been widely used around the world for different everyday tasks. However, every day there is also an increasing dumping of these electronic devices, especially smartphones, creating a public health problem called electronic waste or e-waste. This Viewpoint discusses how e-waste could be used by governments to promote digital health policies, especially in poorer countries. The use of e-waste could lower health care costs and reduce exposure to the metals contained in these materials.

Digital therapeutics (DTx) are a new treatment class for major depressive disorder (MDD). This study evaluated the effectiveness and safety of a novel DTx, CT-152 (Rejoyn™), for MDD adjunctive to antidepressant medication monotherapy.

Adults aged 22-64 years with MDD having an inadequate response to current antidepressant medication monotherapy were enrolled in a phase 3 multicenter, randomized, blinded, sham-controlled, remote trial with a 6-week intervention and 4-week extension. Delivered via smartphone apps, the CT-152 group received a cognitive-emotional and behavioral therapeutic intervention; the control group received a sham app with a working memory task. Both groups received supportive text messages and continued current antidepressant medication. The primary outcome was Montgomery-Åsberg Depression Rating Scale (MADRS) score change from baseline to week 6. Treatment-emergent adverse events (TEAEs) were assessed.

Overall, 386 participants were randomly assigned (CT-152, n = 194; sham, n = 192). In the primary efficacy analysis of participants with ≥ 1 treatment session and ≥ 1 MADRS assessment post-baseline (n = 354), MADRS score changed -9.03 in the CT-152 group and - 7.25 in the sham (difference, - 1.78; P = 0.0568). These results were consistent with data from additional patient and clinician scales. In a supportive analysis of the intent-to-treat sample (N = 386), the between-group difference in 6-week MADRS change from baseline was -2.12 (P = 0.0211), favoring CT-152. No TEAEs or discontinuations were considered related to CT-152, and no deaths occurred.

CT-152 resulted in depression symptom improvement and a favorable safety profile. Based on these data, CT-152 became the first FDA-authorized prescription DTx for the adjunctive treatment of MDD.

In the modern era of constant digital technological advancements, problematic smartphone use has become a key issue in educational psychology. This phenomenon affects individual psychological well-being and academic or other performance and encompasses interpersonal relationships and societal aspects, divulging the intricate correlation between technology usage and human behavior. This study aims to explore mindfulness as an intervention measure to lessen problematic smartphone use.

Based on the PRISMA method, this study used a meta-analytic approach to explore the relationship between mindfulness and problematic smartphone use systematically. Systematic literature searches for papers published before February 2024 yielded 29 studies, including 17,534 individuals and 30 effect sizes. The sample comprised participants from Eastern cultures (n = 22 studies) and Western cultures (n = 8 studies).

The meta-analysis revealed a significant negative correlation between mindfulness and problematic smartphone use (r = -0.399, 95 % CI [-0.457, -0.338], p < 0.001). Moderator analyses revealed the strongest relationship when using the Child and Adolescent Mindfulness Measure (CAMM) (r = -0.498), while the Five Facet Mindfulness Questionnaire (FFMQ) showed the weakest (r = -0.245). Cultural background analyses indicated stronger effects in Eastern cultures (r = -0.428) compared to Western cultures (r = -0.316). Gender analyses revealed stronger effects among female participants (β = -0.510, p < 0.05).

These findings demonstrate that mindfulness serves as an effective approach to addressing problematic smartphone use. The significant moderating effects identified have important implications for the implementation of mindfulness-based interventions in educational settings.

The increasing prevalence of stress underscores the demand for effective, self-administered mobile mental health interventions, yet their efficacy and accessibility are still unclear. Here, this systematic review and meta-analysis aimed to classify self-administered mobile stress management interventions, compare their efficacy and examine their moderators. We searched PsycINFO, PubMed, Web of Science, MEDLINE, Embase, CINAHL, Scopus and PsycARTICLES from database inception to 20 November 2023. Eligible studies were randomized controlled trials on peer-reviewed, Internet-based, self-administered psychological interventions for stress reduction in healthy or subhealthy adults. A total of 63 studies with 20,454 participants were included (68.18% female; mean age 39.14 years). Integrated expert insights with large language models to develop a three-dimensional framework encompassing theoretical foundation, human support and mobile technology. Intervention labels were independently coded by the authors and ChatGPT. The included studies' quality was assessed using the Cochrane Risk of Bias 2.0 tool. Bayesian network meta-analysis and Bayesian meta-regression were used to explore comparative efficacy and potential moderators. The framework classified and compared 19 mobile stress interventions, identifying key moderating factors for optimization. Stress management programmes, problem-solving therapy and mindfulness meditation ranked the top. There was no conclusive evidence that human support or mobile technology significantly enhanced intervention outcomes. The evidence is subject to sex imbalance and quality risk, while the limited statistical power of meta-regression warrants caution in interpreting moderator effects. Our findings provide insights for designing more effective and scalable stress interventions and offer promising strategies to reduce health service disparities and advance the Sustainable Development Goals.

Probation officers and other professionals who work with youth in the legal system often experience high chronic workplace stress, which can contribute over time to elevations in anxiety, depression, and workplace burnout. Emotion dysregulation appears to function as a common mechanism underlying these elevations, and growing evidence suggests it can be improved with mindfulness meditation. Implemented successfully, app-based meditation programs could provide professionals with real-time tools for mitigating the effects of chronic workplace stress.

This paper describes the protocol for a hybrid type 2 effectiveness-implementation pilot randomized controlled trial (RCT) of Bodhi AIM+, a meditation app adapted with and for professionals who work with youth in the legal system. The adaptation process and implementation plan, as well as the pilot RCT design, were guided by theoretically driven implementation science frameworks. The primary outcome of the pilot RCT is app adherence (ie, ongoing app usage per objective analytics data).

The RCT will be fully remote. Officers and other professionals who work with youth in the legal system (N=50) will be individually randomized to use the meditation app or an active control app matched for time and structure. All participants will be asked to follow a 30-day path of brief audio- or video-guided content and invited to use additional app features as desired. In-app analytics will capture the objective usage of each feature. An adaptive engagement design will be employed to engage nonusers of both apps, whereby analytics data indicating nonuse will trigger additional support (eg, text messages promoting engagement). Mental health outcomes and potential moderators and covariates will be self-reported at baseline, posttest, and 6 months. Participants will also complete 1-week bursts of ecological momentary assessment (EMA) at baseline and over the last week of the intervention to capture the mechanistic target (ie, emotion regulation) in real time. All participants will be invited to complete qualitative posttest interviews. Descriptive statistics will be calculated for quantitative data. Qualitative data will be analyzed using a combined deductive-inductive approach. The quantitative and qualitative data will be incorporated into a mixed methods triangulation design, allowing for the evaluation of app adherence and other implementation outcomes as well as related barriers and facilitators to implementation.

Enrollment into the trial started in December 2024 and is currently underway. Study results are anticipated to be available in 2026.

Completion of this pilot trial will inform a future, fully powered RCT to formally evaluate the effectiveness and implementation of Bodhi AIM+. Its use of implementation science methods, coupled with digital technology, positions the present study not only to help make meditation tools available to an important workforce at scale but also to inform broader efforts at implementing and evaluating health apps within workplace settings.

ClincialTrials.gov NCT06555172; https://clinicaltrials.gov/study/NCT06555172.

DERR1-10.2196/71867.

There is burgeoning interest in the application of neuroscientific technology to facilitate meditation and lead to beneficial psychological outcomes. One popular approach is using consumer-grade neurofeedback devices to deliver feedback on brain targets during meditation (mindfulness-based neurofeedback). It is hypothesized that optimizing brain targets like alpha and theta band activity may allow meditators to experience deeper mindfulness and thus beneficial outcomes.

This study aimed to systematically review and meta-analyze the impacts of consumer-grade mindfulness-based neurofeedback compared with control conditions. Included studies involved mindfulness practice operationalized as open monitoring or focused attention meditation. This study was preregistered.

A total of 16 randomized controlled training trials, as well as 5 randomized within-participant designs were included, encompassing 763 and 167 unique participants, respectively. Effects were categorized outcomes (ie, psychological distress, cognitive function, and physiological health) and process variables (ie, state mindfulness and brain measures). Study risk of bias, reporting bias, and publication bias were assessed.

Samples were typically small (n=30-50), and the majority of studies used mindfulness apps as controls. To deliver neurofeedback, most studies used the Muse device (11/16 randomized controlled trials [RCTs]). There was a modest effect for decreases in psychological distress compared with controls (k=11, g=-0.16, P=.03), and heterogeneity was low (I2< 0.25). However, there was no evidence for improvements in cognition (k=7, g=0.07, P=.48), mindfulness (k=9, g=0.02, P=.83), and physiological health (k=7, g=0.11, P=.57) compared to controls. Mechanistic modulation of brain targets was not found in RCTs or within-participant designs. Sex (male or female), age, clinical status, study quality, active or passive controls, sample size, and neurofeedback duration did not moderate effects. There was some evidence for reporting bias, but no evidence of publication bias. Adverse effects were not assessed in 19 out of 21 studies and not found in the 2 studies that assessed them.

Assertions that consumer-grade devices can allow participants to modulate their brains and deepen their meditations are not currently supported. It is possible that neurofeedback effects may rely on "neurosuggestion" (placebo effects of neurotechnology). Future research should examine more extensive calibration and individualization of devices, larger sample sizes, and gold-standard sham-controlled RCTs.

Blended mobile health (mHealth) interventions - combining self-guided and human support components - could play a major role in preventing non-communicable diseases (NCDs) and common mental disorders (CMDs). This protocol describes a sequential, multiple assignment, randomised trial aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP, an mHealth lifestyle intervention for the prevention of NCDs and CMDs, and (ii) establishing the optimal blended approach in LvL UP that balances effective personalised lifestyle support with scalability.

LvL UP is a 6-month mHealth holistic intervention targeting physical activity, diet, and emotional regulation. In this trial, young and middle-aged Singaporean adults at risk of developing NCDs or CMDs will be randomly allocated to one of two initial conditions ('LvL UP' or 'comparison'). After 4 weeks, participants categorised as non-responders from the LvL UP group will be re-randomised into second-stage conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional motivational interviewing (MI) support sessions by trained health coaches (LvL UP + adaptive MI). The primary outcome is mental well-being. Secondary outcomes include anthropometric measurements, resting blood pressure, blood metabolic profile, health status, and health behaviours (physical activity, diet). Outcomes will be measured at baseline, 6 months (post-intervention), and 12 months (follow-up).

In addition to evaluating the effectiveness of LvL UP, the proposed study design will contribute to increasing evidence on how to introduce human support in mHealth interventions to maximise their effectiveness while remaining scalable.

The LvL UP Pilot trial was prospectively registered with ClinicalTrials.gov (NCT06360029).

Smartphone apps have the potential to be accessible tools to provide psychoeducation for adults with Attention-Deficit/Hyperactivity Disorder (ADHD). The Adult ADHD App aims to provide psychoeducation about ADHD and supports available in Ireland. The present study aimed to investigate acceptability and user engagement of the Adult ADHD App by auditing real-world use data and gaining qualitative feedback from app users.

App analytical data was audited from the Google Analytics platform. Fourteen app-users, nine of whom identified as women and five as men, with an age range of 26-65 (M = 40.29, SD = 11.14), participated in semi-structured interviews. Reflexive thematic analysis was employed to develop themes on app-users' experiences.

The audit of app analytics indicated that over a period of one year, 12,000 people actively used the app and 6400 users returned after their initial use. We developed four themes from the interviews: 'An evidence-based tool for understanding adult ADHD' highlighted that the Adult ADHD App provides trustworthy psychoeducation on ADHD. 'Recommendations for ADHD-friendly adaptations' identified modifications to improve usability of the app. 'Meeting the needs of different stages in the ADHD journey' showed that while the app significantly benefitted adults new to their ADHD, adults who were familiar with their ADHD sought an app that would help them in moments of challenge. 'Perception of public services impacts app experience' suggested that people's attitudes and experiences of the public health system in Ireland affected their views of app content.

The Adult ADHD App appears to meet its aims of providing psychoeducation on adult ADHD. Elements can be modified to improve usability. Digital health tools created by public health organisations should consider how people's previous experiences with healthcare services can impact how they perceive the information in the tools.

Despite growing popularity, associations between dosage and outcomes in meditation app interventions have not been established. We examined this relationship using a range of operationalizations of dosage (e.g., minutes of use, days of use, number and type of activities completed) and strategies for modeling outcomes (e.g., ordinary least squares regression, multilevel modeling, latent class analysis). We used data from a recently completed randomized controlled trial testing a meditation app (n=662; 80.4% with elevated depression/anxiety) which included psychological distress as its preregistered primary outcome. Across 41 models, whether or not an association was detected as well as the shape and direction of this association varied. Although several models indicated that higher dosage was associated with larger decreases in psychological distress, many models failed to show this relationship and some even showed the opposite. These results may have implications for optimizing and studying dosage in meditation apps and for open science practices.

Mental health concerns have become increasingly prevalent; however, care remains inaccessible to many. While digital mental health interventions offer a promising solution, self-help and even coached apps have not fully addressed the challenge. There is now a growing interest in hybrid, or blended, care approaches that use apps as tools to augment, rather than to entirely guide, care. The Digital Clinic is one such model, designed to increase access to high-quality mental health services.

To assess the feasibility, acceptability, and potential efficacy of the Digital Clinic model, this study aims to conduct a nonrandomized open trial with participants experiencing depression, anxiety, or both, at various levels of clinical severity.

Clinicians were trained in conducting brief transdiagnostic evidence-based treatment augmented by a mental health app (mindLAMP); digital navigators were trained in supporting participants' app engagement and digital literacy while also sharing app data with both patients and clinicians. Feasibility and acceptability of this 8-week program were assessed against a range of benchmarks. Potential efficacy was assessed by calculating pre-post change in symptoms of depression (Patient Health Questionnaire-9; PHQ-9), anxiety (7-item Generalized Anxiety Disorder; GAD-7), and comorbid depression and anxiety (Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS), as well as rates of clinically meaningful improvement and remission. Secondary outcomes included change in functional impairment, self-efficacy in managing emotions, and flourishing.

Of the 258 enrolled participants, 215 (83.3%) completed the 8-week program. Most were White (n=151, 70.2%) and identified as cisgender women (n=136, 63.3%), with a mean age of 41 (SD 14) years. Feasibility and acceptability were good to excellent across a range of domains. The program demonstrated potential efficacy: the average PHQ-9 score was moderate to moderately severe at baseline (mean 13.39, SD 4.53) and decreased to subclinical (mean 7.79, SD 4.61) by the end of the intervention (t126=12.50, P<.001, Cohen d=1.11). Similarly, the average GAD-7 score decreased from moderate at baseline (mean 12.93, SD 3.67) to subclinical (mean 7.35, SD 4.19) by the end of the intervention (t113=13, P<.001, Cohen d=1.22). Participation in the program was also associated with high rates of clinically significant improvement and remission.

Results suggest that the Digital Clinic model is feasible, acceptable, and potentially efficacious, warranting a future randomized controlled trial to establish the efficacy of this innovative model of care.

Digital applications, such as in smartphone apps format, have shown high suggestive evidence for their efficacy in reducing general distress, but rigorous studies of their efficacy in symptom change and the mechanisms involved are still needed.

In the current multi-arm parallel-group randomized trial, participants aged 18-65 with smartphone access were recruited through social media. They were randomly assigned to two app interventions (PsyPills and OCAT) or an active placebo group (shamOCAT). The primary outcome was psychological distress measured up to one month.

A total of 229 participants from diverse regional and demographic groups of the general population of Romania were randomly allocated into the three groups (PsyPills n = 80; OCAT n = 70; shamOCAT n = 79) and included in intention-to-treat analyses. Both the PsyPills (MD = -522; 95%CI = -10.00 to -0.44; d = 0.48) and OCAT (MD = -6.30; 95%CI = -11.39 to -1.21; d = 0.58) reduced significantly, with medium effect sizes, the psychological distress levels compared with the control group at follow-up. For the separate outcomes, only PsyPills showed significant medium reduction effects for anxiety symptoms (MD = -2.17; 95%CI = -3.83 to -0.50; d = -0.60), while OCAT showed reduction effects of small size for depression (MD = -1.50 (95%CI = -3.53 to 0.54, d = -0.34), that was however statistically nonsignificant.

We registered high attrition and low adherence rates. Also, lower-than-planned effects might have been statistically underpowered to detect.

The results support the high potential of both apps as scalable tools to provide low-intensity self-guided interventions for common psychological problems in the general population and expand opportunities for further research (e.g., confirm and capitulate on the differential effects).

Loneliness affects many older adults. As part of the "Telephone Angel" project, telephone partnerships between volunteers and older adults affected by loneliness were designed to counteract experiencing loneliness. Volunteers (100 ≤ N ≤ 114) and older adults who are (22 ≤ N ≤ 45) and who are not (25 ≤ N ≤ 71) part of the project were surveyed twice. Concerning loneliness, telephone partnerships increased the sense of community (d = .38). Older adults' life satisfaction increased (d = .46) as well. Stigmatization increased between the survey periods for those inside and outside the project (.21 ≤ d ≤ .35).

Globally, 10% of pregnant women and 13% of postpartum women experience mental disorders. In Bangladesh, nearly 50% of mothers face common mental disorders, but mental health services and trained professionals to serve their needs are scarce. To address this, the government of Bangladesh's Non-Communicable Disease Control program initiated "Wellbeing Centers," telemental health services in selected public hospitals.

This study examines implementation outcomes, including adoption, accessibility, acceptability, feasibility, usefulness, need, experience, perception, and expectations of the Wellbeing Centers, with a focus on antepartum and postpartum women.

Between January 2023 and August 2024, we interviewed 911 antepartum and postpartum women receiving mental health services and 168 health care providers at 6 Wellbeing Centers in 4 districts in Bangladesh. Data collection involved both quantitative and qualitative methods. Implementation outcomes were measured following the World Health Organization's implementation research framework. Depression and anxiety symptoms were assessed using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaires. Descriptive statistics and adjusted odds ratios (aORs) with 95% CIs were used to evaluate the implementation outcomes. Qualitative information was obtained through in-depth interviews and key-informant interviews.

Almost all health care providers (165/168, 98.2%) reported that the Wellbeing Centers were feasible to implement in their health facilities; however, about half (84/168, 50%) felt that trained staff to operate them were insufficient. Almost all women agreed that the Wellbeing Centers were acceptable (906/911, 99.8%), useful (909/911, 99.8%), and enhanced access to mental health care (906/911, 99.5%). Patients visiting district-level hospitals had higher odds of access (aOR 1.5, 95% CI 1.1-2.0) to Wellbeing Centers. Moreover, 77.4% (705/911) of women experienced depression symptoms, and 76.7% (699/911) experienced anxiety symptoms. About 51.8% (472/911) experienced tiredness or lack of energy, 50.9% (464/911) felt nervous, anxious, or on edge, 57.2% (521/911) felt worried, and 3.8% (35/911) had suicidal ideation almost every day. Patients visiting district hospitals had higher odds (aOR 2.6, 95% CI 1.8-3.78) of depression and anxiety symptoms compared to the patients visiting subdistrict-level hospitals. Decreasing trends in Patient Health Questionnaire-9 scores (from mean 14.4, SD 0.47 to mean 12.9, SD 0.47) and Generalized Anxiety Disorder-7 scores (from mean 13.3, SD 0.49 to mean 12.5, SD 0.48) between 2 counseling sessions indicated improved mental health in the antepartum and postpartum women. The Wellbeing Centers' services were appreciated for their privacy and being free and accessible. However, stigma, postpartum illness, and long waiting times prevented some women from using these services.

To our knowledge, this is the first implementation research assessing telemental health in public health facilities involving trained psychologists and psychiatrists. Our study highlighted the increased accessibility, feasibility, acceptability, and utility of Wellbeing Centers for antepartum and postpartum women in Bangladesh, supporting their scale-up in similar settings.

The use and perceptions of smartphone-based mental health applications (MH-Apps) in Saudi Arabia require exploration. This study investigated MH-App use among Saudi Arabian healthcare workers (HCWs), including psychiatrists, psychologists, and family medicine physicians. It also assessed HCWs' interest in and willingness to integrate these apps into their practices, as well as their cognitive flexibility and its relationship with their attitudes and app use. This cross-sectional study involved 386 participants recruited using convenience and snowball sampling. The Cognitive Flexibility Scale (CFS) was used to assess cognitive flexibility. The results showed that 33.2% of HCWs downloaded MH-Apps, with 67.9% considering them somewhat beneficial. However, most had not yet tried them. Only 7% of HCWs strongly agreed that these apps are evidence-based. Concerns about using these apps in their practices were reported by 36.5% of HCWs, with the most common concern being the lack of evidence-based support. The primary reason for downloading MH-Apps for personal use was to improve mental well-being, whereas patient-related use was psychoeducation. Furthermore, 27.5% of HCWs recommended MH-Apps to their patients, with old age, women, and psychiatrists/psychologists more likely to recommend them. Higher CFS scores were more strongly associated with older HCWs, those who had ever recommended MH-Apps, and those who used the apps. Saudi Arabian HCWs should be encouraged to use and recommend MH-Apps, with more evidence-based research needed to address concerns. Further research on cognitive flexibility's implications for clinical practice is also warranted.

Mobile health (mHealth) interventions have gained popularity in augmenting psychiatric care for adults with psychosis. Interest has grown in leveraging mHealth to empower individuals living with severe mental illness and extend continuity of care beyond the hospital to the community. However, reported outcomes have been mixed, likely attributed in part to the intervention and adopted outcomes, which affected between-study comparisons.

This study aimed to critically review outcome measures used to evaluate mHealth interventions for adults with psychosis in relation to the characteristics of mHealth interventions.

A systematic mapping review was conducted. We searched PubMed, CINAHL, Embase, PsycINFO, and Cochrane Libraries from 1973 to the present. Selection criteria included randomized controlled studies of mHealth interventions in adults diagnosed with schizophrenia spectrum disorders. Reviewers worked in pairs to screen and extract data from included studies independently using a standardized form; disagreements were resolved by consensus with an independent reviewer. We report our findings in line with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines.

A total of 1703 citations were screened; 29 publications reporting on 23 studies were included in this review. mHealth interventions for psychosis span a wide range, with psychological therapy being the most-deployed intervention (12/23, 52%), followed by psychoeducation (8/23, 35%) and active self-monitoring (8/23, 35%). Several mHealth interventions for psychosis targeted multiple pillars of biopsychosocial well-being (10/23, 43%); the bulk of interventions (16/23, 70%) incorporated features promoting users' self-management. The majority of mHealth interventions were delivered through applications (14/23, 61%) as the main medium and smartphones (17/23, 74%) as the main channel of delivery. Interventions were primarily administered in the outpatient and community settings (16/23, 70%); many were also blended with in-person sessions (11/23, 48%) or guided remotely (6/23, 26%) by persons, including health care providers or trained peer supporters. The severity of psychosis-related symptoms (21/23, 91%) was the most prevalent outcome, of which positive symptoms (13/23, 57%), mood and anxiety (10/23, 43%), and overall psychopathology severity (9/23, 39%) were most commonly measured. Patient-centric outcomes, including well-being (17/23, 74%)-particularly quality of life (10/23, 43%)-and user experience (15/23, 65%), including feasibility (7/23, 30%), acceptability (7/23, 30%), and engagement (7/23, 26%). Notably, outcome choices remained diverse despite stratification by type of mHealth intervention.

mHealth interventions for psychosis encompass a wide range of modalities and use outcome measures that probe various social and behavioral determinants of health. These should be considered complex interventions, and a holistic evaluation approach combining clinical and patient-centric outcomes is recommended.

Many adolescents in Uganda are affected by common mental disorders, but only a few affordable treatment options are available. Digital mental health interventions offer promising opportunities to reduce these large treatment gaps, but interventions specifically tailored for Ugandan adolescents are limited.

This study aimed to determine the feasibility and acceptability of the Kuamsha program, an intervention delivered through a gamified app with low-intensity telephonic guidance, as a way to promote mental health among adolescents from the general population in Uganda.

A 3-month pre-post single-arm trial was conducted with adolescents aged between 15 and 19 years living in Wakiso District, Central Uganda. The intervention was coproduced with adolescents from the study site to ensure that it was culturally acceptable. The feasibility and acceptability of the intervention were evaluated using an explanatory sequential mixed methods approach. Feasibility was assessed by collecting data on trial retention rates and treatment adherence rates. Acceptability was assessed through a questionnaire and in-depth interviews with participants following the conclusion of the intervention period. As a secondary objective, we explored the changes in participants' mental health before and after the intervention.

A total of 31 adolescents were recruited for the study. Results from the study showed high levels of feasibility and acceptability. Trial retention rates exceeded 90%, and treatment adherence was ≥80%. These results, evaluated against our predefined trial progression criteria, indicate a successful feasibility study, with all criteria exceeding the thresholds necessary to progress to a larger trial. App engagement metrics, such as time spent on the app and modules completed, exceeded existing literature benchmarks, and many adolescents continued to use the app after the intervention. In-depth interviews and questionnaire responses revealed high acceptability levels. Depressive symptoms trended toward reduction (mean difference: 1.41, 95% CI -0.60 to 3.42, Cohen d=0.30), although this was not statistically significant (P=.16). Supporting this trend, we also observed a reduction in the proportion of participants with moderate depressive symptoms from 32% (10/31) to 17% (5/29) after the intervention, but this change was also not significant (P=.10).

This study presents evidence to support the Kuamsha program as a feasible and acceptable digital mental health program for adolescents in Uganda. A fully powered randomized controlled trial is needed to assess its effectiveness in improving adolescents' mental health.

Mobile-based screening interventions to detect and treat Major Depressive Disorder (MDD) at an early stage might be a promising approach for reducing its societal burden. In the present study, we will evaluate the feasibility and effectiveness of screening for MDD using a mobile-based screening protocol.

This study will be a three-arm, parallel randomized control trial (RCT) performed in a multi-ethnic population within the municipality of Rotterdam (the Netherlands). The trial includes two intervention groups that will be screened 4-weekly for MDD for 12 months using the Patient Health Questionnaire (PHQ-9) and a control group who does not receive mobile-based screening for MDD. Participants in the one-test intervention arm will be referred for further diagnosis and treatment, if necessary, after a single positive test score for moderate-severe major depression symptoms (PHQ-9 > 10). Participants in the multiple-test intervention arm will only be referred after three consecutive positive test scores. 1786 eligible participants will be included in the RCT, with 446 and 447 in the one-test and multiple-test referral arms, respectively, and 893 in the control arm. Primary outcome is participants' QoL after 12 months (EQ-5D-5L). Secondary outcomes include participants' QoL after 24 months (EQ-5D-5L), evaluating the occurrence and severity of MDD symptoms (PHQ-9), intervention engagement, and identifying public mental health differences based on sociodemographic characteristics, including age, gender, ethnicity, financial situation, educational background, and living area. Long-term results of the RCT will be incorporated into a microsimulation model to determine the long-term benefits, harms, and costs of MDD screening.

The information gained from examining the feasibility and (cost-) effectiveness of mobile-based screening for MDD could be of guidance for mental health policy implementations and support the introduction of mobile-based screening for MDD in the Netherlands and/or other nations.

ClinicalTrials.gov: NL84280.078.23, NCT05989412 , August 8, 2024.

With 1 in 3 adults globally living with chronic conditions and the rise in smartphone ownership, mobile health apps have become a prominent tool for managing lifestyle-related health behaviors and mental health. However, high rates of app abandonment pose challenges to their effectiveness.

We explored the abandonment of apps used for managing physical activity, diet, alcohol, smoking, and mental health in free-living conditions, examining the duration of app use before abandonment and the underlying reasons.

A scoping review was conducted based on the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines and eligibility criteria were designed according to the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type) framework. In total, 4 databases were searched (MEDLINE, Scopus, Embase, and PsycINFO) to identify quantitative and qualitative studies with outcome measures related to app abandonment in adults with free-living conditions, including reasons for abandonment and duration of use, for mobile apps related to WHO (World Health Organization) modifiable health behaviors and mental health. The included studies' risk of bias was appraised based on the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and COREQ (Consolidated Criteria for Reporting Qualitative Research) checklists. To enable data synthesis across different methodologies, app domains, demographic data, and outcome measures were categorized. Results are presented in 2 sections: quantitatively in a scatterplot to understand when users abandon apps and qualitatively through basic qualitative content analysis to identify the underlying reasons.

Eighteen eligible studies (525,824 participants) published between 2014 and 2022, predominantly from the United States, Canada, the United Kingdom, and Germany, were identified. Findings revealed a curvilinear pattern of app abandonment, with sharper abandonment soon after acquisition, followed by a slowing rate of abandonment over time. Taken together, a median of 70% of users discontinued use within the first 100 days. The abandonment rate appeared to vary by app domain, with apps focusing on alcohol and smoking exhibiting faster abandonment, and physical activity and mental health exhibiting longer usage durations. In total, 22 unique reasons for abandonment were organized into six categories: (1) technical and functional issues, (2) privacy concerns, (3) poor user experience, (4) content and features, (5) time and financial costs, and (6) evolving user needs and goals.

This study highlights the complex nature of health app abandonment and the need for an improved understanding of user engagement over time, underscoring the importance of addressing various factors contributing to abandonment, from technical issues to evolving user needs. Our findings also emphasize the need for longitudinal studies and a consistent definition of app abandonment to better understand and mitigate this phenomenon, thereby enhancing the effectiveness of health apps in supporting public health initiatives.

Paranoia, the belief that you are at risk of significant physical or emotional harm from others, is a common difficulty, which causes significant distress and impairment to daily functioning, including in psychosis-spectrum disorders. According to cognitive models of psychosis, paranoia may be partly maintained by cognitive processes, including interpretation biases. Cognitive bias modification for paranoia (CBM-pa) is an intervention targeting the bias towards interpreting ambiguous social scenarios in a way that is personally threatening. This study aims to test the efficacy and safety of a mobile app version of CBM-pa, called STOP (successful treatment of paranoia).

The STOP study is a double-blind, superiority, three-arm randomised controlled trial (RCT). People are eligible for the trial if they experience persistent, distressing paranoia, as assessed by the Positive and Negative Syndrome Scales, and show evidence of an interpretation bias towards threat on standardised assessments. Participants are randomised to either STOP (two groups: 6- or 12-session dose) or text-reading control (12 sessions). Treatment as usual will continue for all participants. Sessions are completed weekly and last around 40 min. STOP is completely self-administered with no therapist assistance. STOP involves reading ambiguous social scenarios, all of which could be interpreted in a paranoid way. In each scenario, participants are prompted to consider more helpful alternatives by completing a word and answering a question. Participants are assessed at baseline, after each session, and at 6, 12, 18 and 24 weeks post-randomisation. The primary outcome is the self-reported severity of paranoid symptoms at 24 weeks, measured using the Paranoia Scale. The target sample size is 273 which is powered to detect a 15% symptom reduction on the primary outcome. The secondary outcomes are standardized measures of depression, anxiety and recovery and measures of interpretation bias. Safety is a primary outcome and measured by the Negative Effects Questionnaire and a checklist of adverse events completed fortnightly with researchers. The trial is conducted with the help of a Lived Experience Advisory Panel.

This study will assess STOP's efficacy and safety. STOP has the potential to be an accessible intervention to complement other treatments for any conditions that involve significant paranoia.

ISRCTN registry, ISRCTN17754650. Registered on 03/08/2021.  https://doi.org/10.1186/ISRCTN17754650 .

Stress is a significant mental health concern for the general population, highlighting the need for effective and scalable solutions, such as mobile health (mHealth) app interventions. This systematic review and meta-analysis aimed to investigate the effects of mHealth apps designed primarily to reduce stress and distress in non-clinical and subclinical populations. A comprehensive literature search was conducted up to August 2024, including studies that measured both self-reported and physiological stress outcomes. 80 studies were analyzed. A small but significant effect size (g = 0.33) was found for self-reported stress outcomes, with studies that used specific active controls, operated in naturalistic contexts, and had a low risk of bias showing significantly lower effect sizes. A similarly small effect size was observed for physiological outcomes (g = 0.24). Notably, studies that employed muscle and breathing relaxation, meditation strategies, personalized guidance, experimental usage settings, and measured acute stress responses demonstrated significantly higher effect sizes. Further analysis of specific physiological systems revealed small effect sizes for autonomic (g = 0.32) and cardiac outcomes (g = 0.36). The significant effects observed across both psychological and physiological outcomes support the efficacy and potential of mHealth apps for the self-management of stress responses in the broader population.

Digital innovations can reduce the global burden of depression by facilitating timely and scalable interventions. In recent years, the number of commercial Digital Health Interventions for Depression (DHIDs) has been on the rise. However, there is limited knowledge on their content and underpinning scientific evidence. This study aimed to: (i) identify the top-funded companies offering DHIDs and (ii) provide an overview of their interventions, including scientific evidence, psychotherapeutic approaches and use of novel technologies.

A systematic search was conducted using two venture capital databases to identify the top-30 funded companies offering DHIDs. In addition, studies related to the DHIDs' were identified via academic databases and hand-searching. The methodological quality of the publications was evaluated using the Mixed Methods Appraisal Tool.

The top-30 funded companies offering DHIDs received a total funding of 2,592 million USD. Less than half of the companies produced any scientific research associated with their DHIDs, with a total of 83 publications identified. Twenty-five publications were randomised control trials, of which 15 reported moderate-to-large effects in reducing depression symptoms. Regarding novel technologies, few DHIDs incorporated the use of conversational agents or low-burden sensing technologies.

Funding received by top-funded companies was not related to the amount of scientific evidence provided on their DHIDs. There was a strong variation in the quantity of evidence produced and an overall need for more rigorous effectiveness trials. Few DHIDs used automated approaches such as conversational agents, limiting their scalability.

This umbrella review of 34 meta-analyses, representing 235 randomised controlled trials done across 52 countries and 48 957 participants and ten chronic conditions, aimed to evaluate evidence on the efficacy of mobile phone interventions for populations with chronic diseases. We evaluated the strengths of evidence via the Fusar-Poli and Radua methodology. Compared with usual care, mobile apps had convincing effects on glycated haemoglobin reduction among adults with type 2 diabetes (d=0·44). Highly suggestive effects were found for both text messages and apps on various outcomes, including medication adherence (among patients with HIV in sub-Saharan Africa and people with cardiovascular disease), glucose management in type 2 diabetes, and blood pressure reduction in hypertension. Many effects (42%) were non-significant. Various gaps were identified, such as a scarcity of reporting on moderators and publication bias by meta-analyses, little research in low-income and lower-middle-income countries, and little reporting on adverse events.

Self-efficacy is associated with positive mental health outcomes. We developed and tested a digital self-efficacy training for daily recall of autobiographical self-efficacy memories (e.g., memories of successfully overcoming a personal challenge).

In this randomized controlled trial, we investigated the effects of the week-long digital self-efficacy training on key mental health outcomes, including anxiety, stress, and hopelessness, and on self-efficacy in 93 university students (mean age 23.3 years, SD: 3.49) with elevated self-reported stress levels. Participants completed either the self-efficacy training combined with ecological momentary assessment (EMA) (training group) or EMA only (control group).

We found significantly reduced hopelessness and trait anxiety in the training group compared to the control group at post-assessment (one day post intervention). Effects on ratings of self-efficacy at post-assessment were also significant when controlling for baseline self-efficacy.

This stand-alone digital self-efficacy training was significantly associated with a number of positive effects on outcomes compared to a control condition, including reduced hopelessness, trait anxiety, and increased self-efficacy. Future work is needed to replicate and investigate the long-term effects of the training and explore its implementation in clinical populations.

ClinicalTrials.gov Identifier: NCT05617248.

The global mental health crisis underscores the need for accessible, effective interventions. Chatbots based on generative artificial intelligence (AI), like ChatGPT, are emerging as novel solutions, but research on real-life usage is limited. We interviewed nineteen individuals about their experiences using generative AI chatbots for mental health. Participants reported high engagement and positive impacts, including better relationships and healing from trauma and loss. We developed four themes: (1) a sense of 'emotional sanctuary', (2) 'insightful guidance', particularly about relationships, (3) the 'joy of connection', and (4) comparisons between the 'AI therapist' and human therapy. Some themes echoed prior research on rule-based chatbots, while others seemed novel to generative AI. Participants emphasised the need for better safety guardrails, human-like memory and the ability to lead the therapeutic process. Generative AI chatbots may offer mental health support that feels meaningful to users, but further research is needed on safety and effectiveness.

Smartphone app interventions based on cognitive-behavioral therapy (CBT) are promising scalable alternatives for treating mental disorders, but the evidence of their efficacy for postpartum depression is limited. We assessed the efficacy of Motherly, a standalone CBT-based smartphone app, in reducing symptoms of postpartum depression.

Women aged 18-40 with symptoms of postpartum depression were randomized either to intervention (Motherly app) or active control (COMVC app). The primary outcome was symptoms of depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at post-treatment. Secondary outcomes were anxiety symptoms, parental stress, quality of sleep, behavioral activation, availability of response-contingent positive reinforcement, and clinical improvement at post-treatment and 1-month follow-up. Exploratory analyses were performed to investigate if app engagement was associated with treatment response.

From November 2021 to August 2022, 1,751 women volunteered, of which 264 were randomized, and 215 provided primary outcome data. No statistically significant differences were found between groups at post-treatment: intervention: mean (SD): 12.75 (5.52); active control: 13.28 (5.32); p = 0.604. There was a statistically significant effect of the intervention on some of the secondary outcomes. Exploratory analyses suggest a dose-response relationship between Motherly app engagement and outcomes.

Our standalone app intervention did not significantly reduce postnatal depression symptoms when compared to active control. Exploratory findings suggest that negative findings might be associated with insufficient app engagement. Consistent with current literature, our findings suggest that standalone app interventions for postpartum depression are not ready to be implemented in clinical practice.

Harnessing mobile health (mHealth) solutions could improve the delivery of mental health services and mitigate their impact in Uganda and similar low-resource settings. However, successful adoption requires that mHealth solutions have good usability. We have previously implemented a telephone service to provide mental health information and advice in English and Luganda, utilizing an automated interactive voice response (IVR) system linked to live agents, including mental health care workers and peer support workers.

This study aims to assess the usage and usability of this mental health telephone service.

We obtained usage data from the system's call logs over 18 months to study call volumes and trends. We then surveyed callers to gather their characteristics and assess usability using the Telehealth Usability Questionnaire. Additionally, call recordings were evaluated for conversation quality by 3 independent health care professionals, using the Telephone Nursing Dialogue Process, and correlations between quality and usability aspects were investigated.

Over 18 months, the system received 2863 meaningful calls (ie, calls that went past the welcome message) from 1125 unique telephone numbers. Of these, 1153 calls (40.27%) stopped at the prerecorded IVR information, while 1710 calls (59.73%) opted to speak to an agent. Among those who chose to speak with an agent, 1292 calls (75.56%) were answered, 393 calls (22.98%) went to voicemail and were returned in the following working days, and 25 calls (1.46%) were not answered. Usage was generally sustained over time, with spikes in call volume corresponding to marketing events. The survey (n=240) revealed that most callers were caregivers of patients with mental health issues (n=144, 60.0%) or members of the general public (n=46, 19.2%), while a few were patients with mental health issues (n=44, 18.3%). Additionally, the majority were male (n=143, 59.6%), spoke English (n=180, 75.0%), had postsecondary education (n=164, 68.3%), lived within 1 hour or less from Butabika Hospital (n=187, 77.9%), and were aged 25-44 years (n=160, 66.7%). The overall usability score for the system was 4.12 on a 5-point scale, significantly higher than the recommended target usability score of 4 (P=.006). The mean scores for usability components ranged from 3.66 for reliability to 4.41 for ease of use, with all components, except reliability, scoring higher than 4 or falling within its CI. Usability scores were higher for Luganda speakers compared with English speakers, but there was no association with other participant characteristics such as sex, distance from the hospital, age, marital status, duration of symptoms, or treatment status. The quality of call conversations (n=50) was rated at 4.35 out of 5 and showed a significant correlation with usability (Pearson r=0.34, P=.02).

We found sustained usage of the mental health telephone service, along with a positive user experience and high satisfaction across various user characteristics. mHealth solutions like this should be embraced and replicated to enhance the delivery of health services in Uganda and similar low-resource settings.

Mobile Health (mHealth), leveraging nearly 4.5 billion people actively use mobile phone and internet, can be crucial in promoting tobacco cessation. This umbrella review aimed to assess the effectiveness of mobile phone applications in achieving this outcome.

Searches were conducted in databases like Medline, EMBASE, PubMed Central, ScienceDirect, Google Scholar, and Cochrane library from their inception till June 2022, without language restriction. Quality assessment was carried out using the AMSTAR-2 tool. The narrative synthesis findings were presented in terms of the overall effect size reported by the individual systematic review along with the heterogeneity measures and risk of bias assessment findings.

We included 11 reviews, most of which had critical weaknesses in certain domains. Among these, three reviews conducted meta-analyses providing pooled estimates, but the effect sizes were non-significant and imprecise, indicating that mobile phone applications did not have a significant effect on tobacco cessation. Only three reviews concluded a promising role for mobile phone applications in tobacco cessation, particularly when these applications were based on theoretical constructs or combined with face-to-face interventions.

Our review indicates that mobile phone applications could play a promising role in tobacco cessation. However, using a single mobile phone application without any theoretical construct may not sufficiently drive behavioural change to reduce tobacco usage.

Major depressive disorder (MDD) is common worldwide and can be highly disabling. People with MDD face many barriers to treatment and may not experience full symptom relief even when treated. Therefore, new treatment modalities are needed for MDD. Digital therapeutics (DTx) may provide people with MDD an additional treatment option.

This study aimed to describe a phase 3 remote, multicenter, randomized, masked, sham-controlled trial evaluating the efficacy of a smartphone app-based DTx (CT-152) in adult participants diagnosed with MDD, used as an adjunct to antidepressant therapy (ADT).

Participants aged 22-64 years with a current primary diagnosis of MDD and an inadequate response to ADT were included. Participants were randomized 1:1 to CT-152 or a sham DTx. CT-152 is a smartphone app-based DTx that delivers a cognitive-emotional and behavioral therapeutic intervention. The core components of CT-152 are the Emotional Faces Memory Task exercises, brief lessons to learn and apply key therapeutic skills, and SMS text messaging to reinforce lessons and encourage engagement with the app. The sham DTx is a digital working memory exercise with emotionally neutral stimuli designed to match CT-152 for time and attention. Participants took part in the trial for up to 13 weeks. The trial included a screening period of up to 3 weeks, a treatment period of 6 weeks, and an extension period of 4 weeks to assess the durability of the effect. Sites and participants had the option of an in-person or remote screening visit; the remaining trial visits were remote. Efficacy was evaluated using the Montgomery-Åsberg Depression Rating Scale, the Generalized Anxiety Disorder-7, Clinical Global Impression-Severity scale, the Patient Health Questionnaire-9, and the World Health Organization Disability Assessment Schedule 2.0. The durability of the effect was evaluated with the Montgomery-Åsberg Depression Rating Scale and Generalized Anxiety Disorder-7 scale. Adverse events were also assessed. Satisfaction, measured by the Participant and Healthcare Professional Satisfaction Scales, and health status, measured by the EQ-5D-5L, were summarized using descriptive statistics.

This study was initiated in February 2021 and had a primary completion date in October 2022.

This represents the methodological design for the first evaluation of CT-152 as an adjunct to ADT. This study protocol is methodologically robust and incorporates many aspects of conventional pivotal pharmaceutical phase 3 trial design, such as randomization and safety end points. Novel considerations included the use of a sham comparator, masking considerations for visible app content, and outcome measures relevant to DTx. The rigor of this methodology will provide a more comprehensive understanding of the effectiveness of CT-152.

ClinicalTrials.gov NCT04770285; https://clinicaltrials.gov/study/NCT04770285.

RR1-10.2196/56960.

Depression is a common mental disorder. Detecting (sub)clinical depressive symptoms in adolescents at an early stage and offering a low-threshold early intervention can minimize the risk of serious and/or long-term depression. As such, a digital intervention can be a low-threshold preventive and early intervention. This study aims to examine whether the Boost My Mood (BMM)-app is a suitable preventive early intervention for adolescents with (sub)clinical depressive symptoms.

This naturalistic single-arm evaluation study (N = 50) was conducted in adolescents aged 16-21 with (sub)clinical depressive symptoms. Furthermore, the BMM-app was studied in relation to anxiety, worrying, stress, and sleeping problems. An exploratory objective was to determine whether positive expectations and social support are related to app use.

The study showed a significant decrease in not only depressive symptoms, but also anxiety, worrying and stress while using the BMM-app. Sleeping problems did not significantly decrease over time while using the BMM-app. The degree of use of the BMM-app and telling significant others about using the BMM-app were both not related to a decrease in depressive symptoms. The BMM-app was used significantly more when the adolescent had told relatives about their depressive symptoms.

A digital intervention, such as the BMM-app, can be a low-threshold preventive and early intervention for adolescents with (sub)clinical depressive symptoms. Beneficial effects of the BMM-app were reported on depressive symptoms as well as other aspects of quality of life, such as anxiety, worrying, and stress. Whereas several factors may have played a role in the current findings on depressive symptoms, there are reasons to assume that part of the reduction in symptoms could be attributed to the BMM-app. Although no causality can be assumed, this study is a first step in the implementation of preventive apps in mental health care.

Suicidal ideation (SI) is a significant public health concern with increasing prevalence. Therapist-supported digital mental health interventions (DMHI) are an emergent modality to address common mental health problems like depression and anxiety, although less is known about SI. This study examined SI trajectories among 778 patients who participated in a therapist-supported DMHI using multilevel models during and up to 6-months post-treatment. Estimates of associated suicide attempts and deaths by suicide were calculated using published data linking PHQ-9-assessed SI to records of suicide attempts and deaths by suicide. The proportion of participants reporting no SI significantly increased between baseline and end-of-treatment (78.02% to 91.00%). Effect sizes of SI changes between baseline and end-of-treatment, 3-month, and 6-month follow-ups were 0.33 (95%CI = 0.27-0.38), 0.32 (95%CI = 0.27-0.38), and 0.32 (95%CI = 0.27-0.38), respectively. Results also indicated an estimated 30.49% reduction (95%CI = 25.15%-35.13%) in suicide attempts and death by suicide across treatment. This study provides preliminary evidence of the effectiveness of a therapist-supported DMHI in reducing SI.

There is a substantial gap between demand for and availability of mental health services. Digital mental health interventions (DMHIs) are promising tools for bridging this gap, yet little is known about their comparative effectiveness.

To assess whether patients randomized to a cognitive behavioral therapy (CBT)-based or mindfulness-based DMHI had greater improvements in mental health symptoms than patients randomized to the enhanced personalized feedback (EPF)-only DMHI.

SETTING, AND PARTICIPANTS This randomized clinical trial was conducted between May 13, 2020, and December 12, 2022, with follow-up at 6 weeks. Adult patients of outpatient psychiatry services across various clinics within the University of Michigan Health System with a scheduled or recent outpatient psychiatry appointment were recruited. Eligible patients were randomized to an intervention arm. All analyses followed the intent-to-treat principle.

Participants were randomized to 1 of 5 intervention arms: (1) EPF only; (2) Silvercloud only, a mobile application designed to deliver CBT strategies; (3) Silvercloud plus EPF; (4) Headspace only, a mobile application designed to train users in mindfulness practices; and (5) Headspace plus EPF.

The primary outcome was change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9; score range: 0-27, with higher scores indicating greater depression symptoms). Secondary outcomes included changes in anxiety, suicidality, and substance use symptoms.

A total of 2079 participants (mean [SD] age, 36.8 [14.3] years; 1423 self-identified as women [68.4%]) completed the baseline survey. The baseline mean (SD) PHQ-9 score was 12.7 (6.4) and significantly decreased for all 5 intervention arms at 6 weeks (from -2.1 [95% CI, -2.6 to -1.7] to -2.9 [95% CI, -3.4 to -2.4]; n = 1885). The magnitude of change was not significantly different across the 5 arms (F4,1879 = 1.19; P = .31). Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported significantly greater improvements on a suicidality measure subscale compared with the Silvercloud arms (mean difference in mean change = 0.63; 95% CI, 0.20-1.06; P = .004).

This randomized clinical trial found decreases in depression and anxiety symptoms across all DMHIs and minimal evidence that specific applications were better than others. The findings suggest that DMHIs may provide support for patients during waiting list-related delays in care.

ClinicalTrials.gov Identifier: NCT04342494.

Farmers in the United States (U.S.) are exposed to myriad stressors and experience their negative effects, including higher rates of suicide than individuals in some other occupations. However, interventions to address mental health amongst farmers have faced barriers, such as farmers' perceived stigma regarding mental health, time constraints, and geographical isolation. Using text-messaging for intervention delivery may help to address some barriers, as text messages are private, delivered directly to one's phone, and require no travel. Our objective was to develop and assess the feasibility, acceptability, and initial efficacy of a text-messaging mental health literacy intervention tailored to U.S. farmers: Growing Resiliency in Tough Times (GRITT).

U.S. farmers (N = 134) were randomly assigned to an intervention group, who received 12 weeks of text messages regarding mental health literacy, or a control group, who received no treatment. Online pre-test and post-test surveys assessed mental health knowledge, familiarity with relevant mental health resources, self-efficacy to manage stress, and perceived stress. Feasibility was assessed via recruitment and retention data, and intervention group participants completed post-test measures to assess acceptability.

Results indicate that intervention group participants were highly satisfied with the intervention and had higher post-test scores on multiple facets of mental health literacy and self-efficacy to manage farm stress than control group participants. The intervention group experienced a significant drop in perceived stress from pre-test to post-test. Participant retention was relatively high (84%). However, recruitment difficulties call into question intervention feasibility.

Though the intervention was efficacious in enhancing mental health literacy, improving stress management self-efficacy, and reducing stress, difficulties with participant recruitment indicate the need for continued intervention research in this context.

Meditation, yoga, guided imagery, and progressive relaxation are promoted as complementary approaches for health and wellbeing in the United States, but their uptake by different sociodemographic groups is unclear. This study assessed the prevalence and 20 year trends in the use of these practices in US adults between 2002-2022. We examined practice use and associations with sociodemographic and health factors in a population-weighted analysis of n = 134,959 participants across 5 cycles of the National Health Interview Survey. The overall use of meditation (18.3%, 60.53 million), yoga (16.8%, 55.78 million) and guided imagery/progressive relaxation (6.7%, 22.22 million) increased significantly from 2002 to 2022. Growth was consistent across most sociodemographic and health strata, however users of 'Other' race (comprising 54% Indigenous Americans, Odds Ratios; ORs = 1.28-1.70) and users with moderate (ORs = 1.19-1.29) psychological distress were overrepresented across all practices, and those with severe psychological distress were overrepresented in meditation (OR = 1.33) and guided imagery/progressive relaxation (OR = 1.42). Meditation use has accelerated over time for 65 + year olds (OR = 4.22), people not accessing mental health care (OR = 1.39), and less educated (OR = 4.02) groups, potentially reflecting unmet health needs. Health professionals should consider the extensive use of complementary practices in service and treatment planning and consider their risks and benefits.

Cancer has emerged as a considerable global health concern, contributing substantially to both morbidity and mortality. Recognizing the urgent need to enhance the overall well-being and quality of life (QOL) of cancer patients, a growing number of researchers have started using online mindfulness-based interventions (MBIs) in oncology. However, the effectiveness and optimal implementation methods of these interventions remain unknown.

This study evaluates the effectiveness of online MBIs, encompassing both app- and website-based MBIs, for patients with cancer and provides insights into the potential implementation and sustainability of these interventions in real-world settings.

Searches were conducted across 8 electronic databases, including the Cochrane Library, Web of Science, PubMed, Embase, SinoMed, CINAHL Complete, Scopus, and PsycINFO, until December 30, 2022. Randomized controlled trials involving cancer patients aged ≥18 years and using app- and website-based MBIs compared to standard care were included. Nonrandomized studies, interventions targeting health professionals or caregivers, and studies lacking sufficient data were excluded. Two independent authors screened articles, extracted data using standardized forms, and assessed the risk of bias in the studies using the Cochrane Bias Risk Assessment Tool. Meta-analyses were performed using Review Manager (version 5.4; The Cochrane Collaboration) and the meta package in R (R Foundation for Statistical Computing). Standardized mean differences (SMDs) were used to determine the effects of interventions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to assess the potential implementation and sustainability of these interventions in real-world settings.

Among 4349 articles screened, 15 (0.34%) were included. The total population comprised 1613 participants, of which 870 (53.9%) were in the experimental conditions and 743 (46.1%) were in the control conditions. The results of the meta-analysis showed that compared with the control group, the QOL (SMD 0.37, 95% CI 0.18-0.57; P<.001), sleep (SMD -0.36, 95% CI -0.71 to -0.01; P=.04), anxiety (SMD -0.48, 95% CI -0.75 to -0.20; P<.001), depression (SMD -0.36, 95% CI -0.61 to -0.11; P=.005), distress (SMD -0.50, 95% CI -0.75 to -0.26; P<.001), and perceived stress (SMD -0.89, 95% CI -1.33 to -0.45; P=.003) of the app- and website-based MBIs group in patients with cancer was significantly alleviated after the intervention. However, no significant differences were found in the fear of cancer recurrence (SMD -0.30, 95% CI -1.04 to 0.44; P=.39) and posttraumatic growth (SMD 0.08, 95% CI -0.26 to 0.42; P=.66). Most interventions were multicomponent, website-based health self-management programs, widely used by international and multilingual patients with cancer.

App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed to optimize and customize these interventions for individual physical and mental symptoms.

PROSPERO CRD42022382219; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382219.

Technology improves accessibility of psychological interventions for youth. An ecological momentary intervention (EMI) is a digital intervention geared toward intervening in daily life to enhance the generalizability and ecological validity, and to be able to intervene in moments most needed. Identifying working mechanisms of the use of ecological momentary interventions might generate insights to improve interventions.

The present study investigates the working mechanisms of the use and acceptability of an ecological momentary intervention, named SELFIE, targeting self-esteem in youth exposed to childhood trauma, and evaluates under what circumstances these mechanisms of use and acceptability do or do not come into play. A realist evaluation approach was used for developing initial program theories (data: expert interviews and a stakeholders focus group), and subsequently testing (data: 15 interviews with participants, a focus group with therapists, debriefing questionnaire), and refining them.

The SELFIE intervention is offered through a smartphone application enabling constant availability of the intervention and thereby increasing accessibility and feasibility. When the intervention was offered on their personal smartphone, this enhanced a sense of privacy and less hesitance in engaging with the app, leading to increased disclosure and active participation. Further, the smartphone application facilitates the practice of skills in daily life, supporting the repeated practice of exercises in different situations leading to the generalizability of the effect. Buffering against technical malfunction seemed important to decrease its possible negative effects.

This study enhanced our understanding of possible working mechanisms in EMIs, such as the constant availability supporting increased accessibility and feasibility, for which the use of the personal smartphone was experienced as a facilitating context. Hereby, the current study contributes to relatively limited research in this field. For the field to move forward, mechanisms of use, and acceptability of EMIs need to be understood. It is strongly recommended that alongside efficacy trials of an EMI on specific target mechanisms, a process evaluation is conducted investigating the working mechanisms of use.

The current paper reports on a realist evaluation within the SELFIE trial (Netherlands Trial Register NL7129 (NTR7475)).

Mobile phone applications (MPAs) for substance use disorder (SUD) treatment are increasingly used by patients. Although pilot studies have shown promising results, multiple previous systematic reviews noted insufficient evidence for MPA use in SUD treatment-many of the previously published reviews evaluated different trials. Subsequently, we aimed to conduct an umbrella review of previously published reviews investigating the efficacy of MPAs for SUD treatment, excluding nicotine/tobacco because umbrella reviews have been done in this population and the nicotine/tobacco MPA approach often differs from SUD-focused MPAs. No previous reviews have included a statistical meta-analysis of clinical trials to quantify an estimated overall effect. Seven reviews met inclusion criteria, and 17 unique studies with available data were taken from those reviews for the meta-analysis. Overall, reviews reported a lack of evidence for recommending MPAs for SUD treatment. However, MPA-delivered recovery support services, cognitive behavioral therapy, and contingency management were identified across multiple reviews as having promising evidence for SUD treatment. Hedges g effect size for an MPA reduction in substance use-related outcomes relative to the control arm was insignificant (0.137; 95% CI, -0.056 to 0.330; P=.16). In subgroup analysis, contingency management (1.29; 95% CI, 1.088-1.482; τ 2=0; k=2) and cognitive behavioral therapy (0.02; 95% CI, 0.001-0.030; τ 2=0; k=2) were significant. Although contingency management's effect was large, both trials were small (samples of 40 and 30). This review includes an adapted framework for the American Psychiatric Association's MPA guidelines that clinicians can implement to review MPAs critically with patients.