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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000662369
Enrollment
66
Registered
2017-05-08
Start date
2017-08-28
Completion date
2017-10-30
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Antepartum depression or depression during pregnancy is a public health concern due to its adverse impact on the mother’s and child’s health. Despite of high prevalence of antepartum depression, many women have limited or no access to mental health care facilities in rural LMIC's. Furthermore, a suitable intervention for these regions, that is of low cost and non­ professional based, focusing solely on depressive symptoms during pregnancy could not be found in existing literature. In light of these problems, the aim of the proposed study is to explore feasibility and acceptability of part of an evidence-­based peer­ based intervention to reduce early depressive symptoms in pregnant women. Objective: To examine feasibility and acceptability of conducting a peer based low intensity psychosocial intervention in reducing mild to moderate depressive symptoms in pregnant women in rural Bangladesh. Methods: A mixed methods approach incorporating a pilot randomised control trial (RCT) and a qualitative process evaluation will be used in this study. Participants pregnant women will be randomised into into control and intervention groups. The intervention group will receive a peer based, CBT intervention for 5 weeks and control group will continue with the as­usual care. Data collected from control and intervention group at the end of the intervention delivery will be compared for final outcome of the pilot trial. For the process evaluation, intervention group participants and peers will also take part in a semi­structured interview to reflect their views on the intervention. Conclusion: The outcomes of the study will evaluate the feasibility and acceptability of the selected intervention as a stand­alone intervention in reducing antepartum depressive symptoms among rural pregnant women and potential of peer based intervention in primary health care settings in LMICs countries like Bangladesh.

Interventions

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

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's mood are assessed and review of the previous session will be done. After each session pregnant women's will be provided with health charts and asked to fill up the charts as part of homework.

Sponsors

Victoria University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1) Two groups of participants will be included in the study. Peers and pregnant women. Six peers from the local community will be selected to deliver the intervention to intervention group pregnant women. 70 pregnant women will be divided equally in control and intervention group to compare any changes that the selected intervention might have. Inclusion criteria for pregnant women: *Pregnant women between 20 and 30 weeks’ gestation. *Aged 18 years or above. *Scoring 10-14 on the Patient Health Questionnaire (PHQ-9). Inclusion criteria for peer: *Local women sharing similar experience, such as being a mother with similar characteristic like age, religion, ethnicity or socioeconomic status. *Having at least 10th grade school level education or more. Please note that, peer will be healthy volunteers included in the study to deliver the intervention to the pregnant women suffering from mild to moderate depressive symptoms as measured through the depression screening tool (PHQ-9).

Exclusion criteria

Exclusion criteria for pregnant women prior to and during the study 1. Severe depression with or without suicidal ideation. 2. PHQ 9 score more than 14. 3. Diagnosed with any acute medical complications during pregnancy or develops complications during participation in the study. 4. Currently receiving treatment for an acute episode of mental disorder or develops an acute episode during participation in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026