Application of unified protocol as a transdiagnostic treatment for emotional disorders during COVID-19: An internet-delivered randomized controlled trial

Table 1 Study schedule of enrollment, intervention, and assessment

	Enrollment	Pre-allocation	Allocation	Post-intervention
Duration	12 wk	1 wk	12 wk
Eligibility	x
Informed consent	x
Clinical interview	x			x
Demographic question	x
Intervention
Unified protocol			-
Treatment as usual			-
Primary outcome
OASIS		x		x
ODSIS		x		x
Secondary outcomes
DERS		x		x
ESQ		x		x
PANAS		x		x

x: Completed at this stage; -: Intervention period. DERS: Difficulties in Emotion Regulation Scale; ESQ: Emotional Style Questionnaire; OASIS: Overall Anxiety Severity and Impairment Scale; ODSIS: The Overall Depression Severity and Impairment Scale; PANAS: Positive and Negative Affect Schedule.

Table 2 Content and the number of sessions for each module

Module	Schedule	Content and the number of sessions for each module
One1	Week 1	Setting goals and maintaining motivation (1 session)
Two1	Week 2	Understanding emotions (1 sessions)
Three2	Week 3 and 41	Mindful emotion awareness (2 sessions)
Four2	Week 5	Cognitive flexibility (2 sessions)
Five2	Week 6	Countering emotional behaviors (1 sessions)
Six2	Week 7	Understanding and confronting physical sensations (1 session)
Seven2	Weeks 8 to 11	Emotion exposures (5 sessions)
Eight3	Week 12	Recognizing accomplishments and looking to the future (1 session)

¹The modules of three, four, five, six, and seven are core modules.

²The modules of one and two are introductory modules.

³The module of eight is the relapse introductory module.

Table 3 Demographic characteristics of the sample, n = 102

Item characteristic	Baseline value	Control group value	UP group value	Test	P value
Categorical variables
Sex, n (%)
Women	48 (47.1)	21	27	χ² = 0.35	0.55
Man	54 (52.9)	30	24
Principal diagnosis, n (%)
Depressive disorder	45 (44.1)	22	23	χ² = 1.41	0.23
Anxiety disorder	57 (55.9)	26	31
Marital status, n (%)
Single	34 (33.3)	20	14	χ² = 11.33	0.001
In relationship	68 (66.7)	35	33
Psychological disorders, n (%)
MDD	40 (48.6)	18	22
Dysthymia	5 (7.1)	4	1
GAD	34 (31.4)	15	19
SAD	23 (12.9)	11	12
Continues variables (mean ± SD)
Age, yr	28.07 ± 5.07	27.92 ± 4.67	28.18 ± 5.49	t(100) = 0.28	0.77
Anxiety	11.14 ± 1.88	11.35 ± 2.05	10.88 ± 1.69	t(100) = 1.26	0.21
Depression	10.97 ± 3.75	11.24 ± 1.75	10.71 ± 1.70	t(100) = 1.09	0.26
Emotion dysregulation	49.69 ± 7.82	49.08 ± 7.10	50.18 ± 8.04	t(100) = 0.80	0.4
Positive affect	26.49 ± 3.80	26.88 ± 3.92	26.10 ± 3.66	t(100) = 1.05	0.29
Negative affect	27.44 ± 3.42	26.59 ± 3.66	27.74 ± 3.01	t(100) = 1.48	0.14
Healthy emotionality	59.84 ± 8.82	60.33 ± 9.46	58.90 ± 11.35	t(100) = 1.67	0.09

GAD: Generalized anxiety disorder; MDD: Major depressive disorder; SAD: Social anxiety disorder; SD: Standard deviation; t: Independent t-test; UP: Unified protocol.

Table 4 Analysis of covariance at Time 2 to compare the unified protocol with treatment as usual

Measure	Condition	Adjusted mean		Levene’s test		ANCOVA
		TAU	UP	F (1, 100)	Sig	F (1, 99)	P value	η2p	R2
Anxiety
	Time 2	11.81	7.98	3.67	0.058	28.77	< 0.001	0.22	0.23
Depression
	Time 2	12.11	8.03	3.43	0.07	62.02	< 0.001	0.38	0.37
Emotion dysregulation
	Time 2	52.44	48.06	2.34	0.12	6.57	0.012	.06	0.07
Positive affect
	Time 2	26.72	33.14	0.12	0.68	40.75	< 0.001	0.29	0.30
Negative affect
	Time 2	27.01	23.28	1.87	0.17	21.35	< 0.001	0.18	0.16
Healthy emotionality
	Time 2	58.83	65.68	0.19	0.68	12.90	0.001	0.12	0.14

ANCOVA: analysis of covariance; η²p: Partial eta square; R²: Adjusted R square; TAU: Treatment as usual; Time 2: Immediately after treatment; UP: Unified Protocol.

Table 5 Control group and intervention group

Measure	Control group (TAU), n= 51		Intervention group (UP), n= 51
	Time 1	Time 1I	Time 1	Time 1I
Anxiety	11.35 ± 2.05	11.75 ± 2.42	10.88 ± 1.69	8.54 ± 2.83
Depression	11.24 ± 1.75	12.08 ± 2.16	10.71 ± 1.70	8.14 ± 3.03
Emotion difficulties	49.07 ± 7.32	50.31 ± 8.40	50.18 ± 8.04	47.33 ± 9.41
Positive affect	26.88 ± 3.92	26.99 ± 4.22	26.10 ± 3.66	31.97 ± 3.59
Negative affect	26.59 ± 3.66	27.89 ± 3.74	27.74 ± 3.01	23.31 ± 4.92
Healthy emotionality	60.33 ± 9.46	59.47 ± 10.41	58.90 ± 11.35	65.12 ± 10.76

Data are presented as mean ± SD. Time 1I: Posttreatment; TAU: Treatment as usual; UP: Unified protocol.

Table 6 Paired t-test and within-group effect size at post-intervention

Item	Treatment as usual group		Unified protocol group
	t(50)	P value	t(50)	P value	Cohen’s d
Anxiety	0.88	0.37	6.13	< 0.001	0.81
Depression	-1.89	0.06	4.38	< 0.001	0.75
Emotion difficulties	-0.98	0.33	5.45	< 0.001	0.54
Positive affect	0.12	0.8	-7.92	< 0.001	1.39
Negative affect	-0.36	0.72	4.43	< 0.001	0.83
Healthy emotionality	0.53	0.6	-2.16	0.03	0.39