STUDY DESIGN


 Setting
Participants reside in Rawalpindi, Pakistan in the 40 village clusters that comprise the rural Sub-District of Kallar Syedan. 

 

Study Area

Recruitment of Study Participants
All pregnant women residing in the study area at the time of recruitment were screened for depression using the Patient Health Questionnaire Depression Scale (PHQ-9). All women scoring above 10 on the PHQ-9 were invited to join the cohort, while 1/3rd of those who did not meet the threshold were invited to participate. The final sample size at baseline was 1,154 women (584 non-depressed, 570 depressed).  Women were excluded if they were un-married, did not reside in the study area, did not understand any of the study languages (Urdu, Punjabi, or Potohari), or needed immediate medical attention. 


Trial Randomization
Embedded within the Bachpan birth cohort is the Thinking Health PLUS (THPP+) Program, a cluster-randomized trial for a peer-delivered psychosocial depression treatment. The delivery of the intervention was randomized at the village cluster level, such that 20 village clusters received the intervention, and 20 village clusters received enhanced usual care (EUC). For more information on the randomization of the participants, please reference the participant flow diagram below. 

Assessment Timing     

After recruitment, women completed a set of baseline measures. Post-natal assessments are ongoing and have been completed at 3 months, 6 months, 12 months, 24 months, 36 months, and 48 months post-partum for all women not lost to follow-up. All assessments occurred in person except the 48-month interview which was conducted over the phone. 


 

 

 

 

 

 

 

 

 

For more detailed information on the study design, please reference our protocol paper, published in Trials.