Clinical Trials Study
Copyright ©The Author(s) 2023.
World J Psychiatry. Aug 19, 2023; 13(8): 551-562
Published online Aug 19, 2023. doi: 10.5498/wjp.v13.i8.551
Table 1 Baseline characteristics of patients stratified by therapy arm
CharacteristicsBA-M
TAU
P value
Mean or count
SD or %
Mean or count
SD or %
Age32.39.633.811.50.437
GenderMen1730%2442%0.242
Women4070%3358%
Data siteCCP1834%2239%0.880
PIMH2140%2137%
Mayo1426%1425%
EducationBelow primary611%611%0.300
Matric1120%1425%
FA/A Level916%1221%
Other2443%1425%
Middle/secondary611%1119%
Marital statusMarried2747%1933%0.039
Sep/divorced/widowed59%1526%
Unmarried2544%2340%
Family systemNuclear3256%3154%0.999
Joint2544%2646%
Working statusYes2545%2137%0.514
No3155%3663%
SESLower class1425%2137%0.247
Middle or upper class4275%3663%
PHQ (Pre)19.54.920.14.10.487
BADS (Pre)20.28.415.66.30.001
SCL-R (Dep)41.99.943.18.20.506
D1 (Pre)Physical health17.94.914.74.80.001
D2 (Pre)Psychological health12.33.311.73.30.333
D3 (Pre)Social relationships8.42.67.92.60.298
D4 (Pre)Environment22.45.220.05.10.014
Table 2 Characteristics of lost and retained patients
Characteristics

Lost to follow up (n = 11)
Retained (n = 103)
P value
Age, mean (SD)35.27 (13.94)32.83 (10.19)0.469
GenderMen9 (82%)32 (31%)0.003
Women2 (18%)71 (69%)
EducationBelow primary1 (10%)11 (11%)
Matric3 (30%)22 (21%)
FA/A Level1 (10%)20 (19%)0.915
Other3 (30%)35 (34%)
Middle/secondary2 (20%)15 (15%)
Marital statusMarried3 (27%)43 (42%)0.617
Sep/divorced/widowed2 (18%)18 (18%)
Unmarried6 (55%)42 (41%)
Family systemNuclear10 (91%)53 (52%)0.029
Joint1 (9%)50 (49%)
Working statusYes5 (46%)41 (40%)0.989
No6 (55%)61 (60%)
SESLower class6 (55%)29 (28%)0.151
Middle or upper class5 (46%)73 (72%)
PHQ Pre20.18 (2.82)19.79 (4.71)0.786
BADS Pre14.09 (4.11)18.34 (7.90)0.082
SCL-R (Dep)36.91 (9.61)43.14 (8.88)0.030
D1 (Pre)Physical health16.64 (2.94)16.33 (5.26)0.850
D2 (Pre)Psychological health12.18 (3.06)11.94 (3.31)0.818
D3 (Pre)Social relationships8.00 (1.41)8.17 (2.70)0.842
D4 (Pre)Environment20.18 (3.06)21.31 (5.44)0.501
Table 3 Summary of outcome after therapy
Characteristics
BA-M
TAU
P value
n5757
Drop Out4 (7%)7 (12%)0.526
Retained53 (93%)50 (88%)
PHQ (Post), mean (SD)4.19 (3.42)6.18 (3.85)0.006
BADS (Post)34.34 (7.32)27.90 (8.53)< 0.001
SCL-R (Dep)16.00 (8.08)19.96 (7.74)0.013
D1 Physical Health (Post)25.85 (2.91)22.84 (3.35)< 0.001
D2 Psychological Health (Post)19.74 (3.08)17.88 (3.26)0.004
D3 Social Relationships (Post)10.45 (1.96)9.64 (2.15)0.047
D4 Environment (Post)27.83 (4.91)26.48 (4.44)0.147
Number of Sessions9.00 (1.77)8.25 (1.39)0.013
Table 4 Coefficients for the regression of the patient health questionnaire-9 post-therapy measurement on baseline and therapy arm
Characteristics
Estimate
95%CI
P value
Intercept1.205(-1.887, 4.298)0.441
TAU Arm1.946(0.545, 3.347)0.007
Baseline PHQ0.152(0.002, 0.301)0.046
Table 5 Coefficients from the regression for secondary outcomes from analysis of covariance models
Characteristics
Estimate
95%CI
P value
BADS
Intercept36.332(31.629, 41.035)< 0.001
Arm TAU-6.854(-10.076, -3.631)< 0.001
Baseline BADS-0.098(-0.302, 0.107)0.346
SCL-R (Dep)
Intercept0.455(-6.723, 7.633)0.900
Arm TAU3.802(0.960, 6.644)0.009
Baseline SCL-R (Dep)-0.098(-0.302, 0.107)0.346
WHOQOL (D1: Physical)
Intercept22.948(20.662, 25.235)< 0.001
Arm TAU-2.489(-3.737, -1.241)< 0.001
Baseline (D1: Physical)0.162(0.043, 0.281)0.008
WHOQOL (D2: Psychological)
Intercept16.097(13.71, 25.235)< 0.001
Arm TAU-1.614(-2.809, -0.420)0.009
Baseline (D2: Psychological)0.295(0.133, 0.476)0.002
WHOQOL (D3: Social)
Intercept7.836(6.583, 9.089)< 0.001
Arm TAU-0.688(-1.424, 0.048)0.066
Baseline (D3: Social)0.313(0.176, 0.450)< 0.001
WHOQOL (D4: Environment)
Intercept18.072(14.496, 21.648)< 0.001
Arm TAU-0.328(-1.967, 1.312)0.693
Baseline (D4: Environment)0.435(0.283, 0.586)< 0.001
Table 6 Coefficients for the fixed effects of the longitudinal model for patient health questionnaire-9
Characteristics
Estimate
95%CI
P value
Overall Intercept21.536(20.549, 22.524)< 0.001
TAU Arm0.396(-1.010, 1.800)0.582
Session-2.260(-2.363, -2.156)< 0.001
TAU-session interaction0.10203(-0.058, 0.261)0.210