A pilot RCT to assess the feasibility of conducting a peer based low­-intensity psychosocial intervention for reducing depressive symptoms in pregnant women in rural Bangladesh.

• Register: ANZCTR
• Last refreshed on: 11 June 2018
• Main ID: ACTRN12617000662369
• Date of registration: 08/05/2017
• Prospective Registration: Yes
• Primary sponsor: Victoria University
• Public title: A pilot RCT to assess the feasibility of conducting a peer based low­-intensity psychosocial intervention for reducing depressive symptoms in pregnant women in rural Bangladesh.
• Scientific title: A pilot RCT to assess the feasibility of conducting a peer based low-­intensity psychosocial intervention for reducing depressive symptoms in pregnant women in rural Bangladesh.
• Date of first enrolment: 28/08/2017
• Target sample size: 70
• Recruitment status: Completed
• URL: http://www.anzctr.org.au/ACTRN12617000662369.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Mild to moderate depressive symptoms during pregnancy

Intervention(s)

The intervention selected for this study is the antenatal part of the Thinking Healthy Peer-delivered Program (THPP). THPP is a low-intensity cognitive behavioral therapy based intervention that is designed specifically for addressing mild to moderate depressive symptoms during and after pregnancy. In this current study, six peers (local mothers selected from the community) will deliver the session to intervention group participants. The intervention consists of five sessions. The sessions will be delivered on weekly basis for five weeks. Each session will require around forty-five minutes to one hour to deliver. Out of five sessions, first four sessions are individual face-to face sessions. And the final session is a group session, which includes groups of five or six intervention group participants. The sessions will be delivered in the intervention group participant’s home or any other place of conveniences.
The complete THPP consists of 14 sessions, which is delivered for 6 months across both antenatal and postnatal period of pregnancy. The programme is developed with the aim to extend the mental health care in rural low resource settings of low middle-income countries (LMICS). THPP is a modified and simpler version of another World Health Organisation (WHO) approved intervention, named as Thinking Healthy Programme (THP). The THP is the first intervention to be approved by WHO as part of its Mental Health Gap Action Programme that aims to scale up the mental health services for LMICs by the year 2020. A team of researcher from Human Development Research Foundation of Pakistan developed both THPP and THP.
In this current study, only the antenatal part of THPP is selected to evaluate the acceptability and feasibility of the part of the program as a stand-alone peer delivered intervention that might help in reducing depressive symptoms in rural pregnant women residing in low- middle-income countries like Bangladesh. Pregnant women participants will be divided into control and intervention groups to evaluate (i) differences in depressive symptoms in the intervention group after receiving the intervention, and (ii) comparison of depressive symptoms between groups. Peers selected from the local community will be trained to deliver the intervention. The outcome of the trial will be based on the data collected before and after intervention delivery.
The student researcher will receive a two-day training through Skype from one of the master trainer of the original THPP team. After the training, the student researcher will train the peers. Same training materials used in the original RCT of THPP will be used in this current study. The THPP team will also provide monthly supervision in order to ensure that the intervention has been delivered appropriately.
At the end of the intervention delivery, all six peers and 18-20 intervention group participants will take part in a small process evaluation. It will include interviews using semi-structured interview schedules that contain both quantitative and qualitative questions. The process evaluation aims to explore the peers and the intervention groups perception about the intervention. All the interviews during the process evaluation will be audiotaped and transcribed verbatim. This is considered the most useful way to assess an intervention trial. The participants’ in process evaluation will also be asked to complete a list of open and close end questions and rate the multiple components of the project (provider training standard, treatment receipt, treatment delivery, treatment enactment) on a Likert scale. This will help to maintain the overall treatment fidelity of the intervention. The process evaluation will also strengthen the results of RCTs and give an in-depth understanding of what makes the intervention a success or failure.
Description of the sessions:
Session 1 : The introductory session in which peers introduce themselves to the pregnant women and her family. Peers will explain about the THPP programme and set the ground rules for participation. Peers will also talk about family support and encourage family members for active participation in the programme.
Session 2: Session two focuses on pregnant women's personal health and peers will teach the pregnant women to apply the Thinking Healthy Approach to improve their personal health during their pregnancy.

Session 3: Session 3 focuses on improving pregnant women's relationship with people around her through applying Thinking Healthy approach.
Session 4: Session 4 focuses on improving pregnant women's relationship with her unborn child through applying Thinking healthy approach.
Session 5 or Group session: The group session focuses on promoting healthy eating and rest in pregnant women.
In each session Pregnant women'