|
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 %
|
