Unit of randomisation |
Villages (stratified within union councils) |
Individual (stratified by urban/rural area of residence) |
Intra-cluster correlation |
0.07 in the intervention arm |
0.05 in the intervention arm (30 therapists; within-therapist clustering) [22, 32, 33] |
0.05 in the control arm (between-village clustering) [22] |
Loss to follow-up over 6 months |
20 % [22] |
15 % [8] |
Allocation ratio (intervention/control) |
1:1 |
1:1 |
Number of participants |
560 (14 per village; 40 village clusters) |
280 |
Outcome |
Power |
Remission at 6 months (PHQ-9 < 10) of 65 % in the intervention arm vs 45 % in the control arm [22] |
90 % |
86 % |
Remission at 6 months (PHQ-9 ≤ 5) of 38 % in the intervention arm vs 22 % in the control arm [22] |
81 % |
74 % |
Depression severity at 6 months (PHQ-9 score) – effect size 0.4 |
90 % |
84 % |