"Thinking Healthy Programme" for Perinatal Depression in Nepal

NCT ID: NCT05393479

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-12-31

Brief Summary

As many as 1 in 3 women in Nepal suffer from perinatal depression however, they often go unidentified and untreated. Lack of knowledge limited trained human resources, and unavailability of specific maternal mental health services are some of the major barriers impeding help-seeking. To mitigate this gap, the World Health Organization recommended Thinking Healthy Programme (THP), a psychological intervention that can be delivered by non-specialists and has been proven effective for perinatal depression in a resource constrained context. The THP has already been translated and adapted to Nepali context. In this study, the investigators plan to pilot test the intervention and assess its feasibility, acceptability, appropriateness, and preliminary effectiveness when delivered by the Female Community Health Volunteers (FCHVs). The FCHVs are cadre of Nepal Government mobilized for the prevention and promotion of maternal and child health in the community level.

Detailed Description

The Thinking Healthy Programme (THP) is a community based low-intensity psychosocial intervention tailored for perinatal depression in improving outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. The intervention has already been tested in other South Asian context and has been found effective in reducing depressive symptoms and promoting wellbeing even when delivered by a non-specialist with limited education. The intervention is basic and does not require prior knowledge or experience on mental health however, it is preferred that the deliverer should at least know about basics of maternal and childcare. In a resource poor country like Nepal where the investment and human resource for maternal mental health is scanty despite the high burden, the THP can be promising given its effectiveness and cost-effectiveness. The THP has already been adapted to the Nepali context.

For the pilot-testing of THP, 4 health facilities will be selected. The health facilities will be randomized to intervention and control arm (2 health facilities in each arm). A list of pregnant women from the health facility's and FCHV's catchment area will be collected from the health facility's outpatient department (OPD) register and FCHV's register/logbook. Eligible women will be screened by the research assistant using the Patient Health Questionnaire (PHQ-9), a screening tool for depression consisting of 9 questions that has already been validated in Nepal. If the woman scores 10 or above in the screening tool, the research assistant will collect the baseline information within 1 week and will refer the woman to the respective FCHV from the same locality as the woman's. The FCHVs in the intervention arm will meet the woman, administer consent form regarding the "Thinking Healthy Programme" (THP). Participants providing consent will be engaged in the THP programme that will be delivered by the trained FCHV. The FCHVs in the control arm will meet the woman, provide psychoeducation, and refer to the health facility where mental health services are available.

Conditions

Perinatal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm: Thinking Healthy Programme

Perinatal women identified with depression in intervention arm will be engaged in 2 modules, one during pregnancy and one during postnatal. Each module has 3 sessions each focusing on a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. Altogether 8 sessions (including 1 introductory session, 6 THP sessions, and 1 closing session) each lasting 30 minutes to 1 hour will be provided to intervention arm participants. In the third session of each module that deals with "the mother's relationship with others", family members will be engaged as well. Questionnaire evaluation will be conducted at baseline, post-Module 1 (after 2 months from recruitment date) and at 3 months post delivery after completing Module 2 and closing session.

Group Type: EXPERIMENTAL

Thinking Healthy Programme

Intervention Type: BEHAVIORAL

The Thinking Healthy Programme (THP) is a psychological treatment recommended by the World Health Organization for perinatal depression. The THP is based on the basic tenets of cognitive behavioural therapy (CBT) that aims to identify unhealthy thoughts and the vicious effects it has on the emotions and behaviour of a person and transform to healthy thinking style that ultimately impacts one's emotions and behaviour, too. The intervention aims to bring positive outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. A randomized controlled trial (RCT) showed that the intervention was effective in reducing depressive symptoms and disability and improving functioning. Additionally, women receiving THP had higher rate of exclusive breastfeeding, and engaging more with their infants. Similarly, infants of these women were also less likely to have diarrhoeal episode and more likely to complete immunization.

Control Arm: Usual Care

Subjects in the control arm will receive usual care, where perinatal women identified with depression, are provided with psychoeducation about their condition and about the availability of services at the health facility and other health information. They will be then referred to the health facility where trained health workers are available.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thinking Healthy Programme

The Thinking Healthy Programme (THP) is a psychological treatment recommended by the World Health Organization for perinatal depression. The THP is based on the basic tenets of cognitive behavioural therapy (CBT) that aims to identify unhealthy thoughts and the vicious effects it has on the emotions and behaviour of a person and transform to healthy thinking style that ultimately impacts one's emotions and behaviour, too. The intervention aims to bring positive outcomes in three areas - a) mother's health, b) the mother-baby relationship, and c) the mother's relationship with others. A randomized controlled trial (RCT) showed that the intervention was effective in reducing depressive symptoms and disability and improving functioning. Additionally, women receiving THP had higher rate of exclusive breastfeeding, and engaging more with their infants. Similarly, infants of these women were also less likely to have diarrhoeal episode and more likely to complete immunization.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant women
• Should be residing in the FCHV's catchment area
• Should be between 4-7 months pregnant.
• Should have no severe physical health conditions
• Should have depressive symptoms (scores 10 or higher in PHQ-9).

Exclusion Criteria

• Women reporting miscarriage, abortion, or still birth will be excluded from the THP intervention (but referred to the psychosocial counsellor for further care)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Liverpool

OTHER

Sponsor Role: collaborator

Transcultural Psychosocial Organization Nepal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Transcultural Psychosocial Organization Nepal

Kathmandu, Bagmati, Nepal

Countries

Nepal

Other Identifiers

TPONepal

Identifier Type: -

Identifier Source: org_study_id