"Thinking Healthy Programme" for Perinatal Depression in Nepal

NCT05393479 | Unknown DMC

• 1 other identifier: TPONepal
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression

Keywords

perinatal depression; psychological intervention; nonspecialist; low and middle income countries; pilot cluster randomized control trial

Outcome Measures

Primary Outcomes (7)

• Change in Female Community Health Volunteers' clinical skills to provide psychological support

  Competency of Female Community Health Volunteers will be assessed through Ensuring Quality in Psychological Support (EQUIP), an online platform consisting of a tool to assess clinical competency of mental health and psychosocial service providers. A service providers' competency is assessed in a Likert scale where 1 represents having harmful behaviour, 2 represents having any or none of the basic helping skills, 3 represents having all basic skills and 4 represents having any advanced skills.

  From pre training to immediate post training

• Qualitative Information: Feasibility from service providers' perspective

  Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about the feasibility of recruiting women with perinatal depression, delivering intervention in the community setting, engaging women, and their family members in the session.

  Month 18

• Qualitative Information: Feasibility from service users' perspective

  Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore feasibility in terms of engaging in the session, scheduling time for session, and completing tasks.

  3 months postnatal

• Qualitative Information: Acceptability from service providers' perspective

  Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their experience delivering intervention focusing on facilitators and barriers, perceived benefits and challenges of intervention for perinatal depression, and their willingness to engage as deliver agents in the future.

  Month 18

• Qualitative Information: Acceptability of of Thinking Healthy Programme from service users' perspective

  Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore facilitators and barriers to engage in the session, perceived benefits and challenges of receiving intervention in the home setting, and their perception of the service provider.

  3 months postnatal

• Qualitative Information: Appropriateness of Thinking Healthy Programme from service providers' perspective

  Service providers who deliver the Thinking Healthy Programme for duration of project will be asked through Focus Group Discussion and Key Informant Interviews about their perception towards the intervention, its utility, suitability in Nepali context.

  Month 18

• Qualitative Information: Appropriateness of Thinking Healthy Programme from service users' perspective

  Women with perinatal depression and their family members engaged in the Thinking Healthy Programme will be interviewed to explore their perception towards the intervention, its utility, suitability for their problem.

  3 months postnatal

Secondary Outcomes (11)

• Changes in Patient Health Questionnaire-9+1

  Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)

• Changes in Generalized Anxiety Disorder Scale

  Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)

• Changes in World Health Organization's Disability Assessment Schedule

  Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)

• Changes in Alcohol Use Disorder Identification Test

  Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)

• Changes in Internalized Stigma of Mental Illness

  Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)

Study Arms (2)

Intervention Arm: Thinking Healthy Programme

EXPERIMENTAL

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.

Behavioral: Thinking Healthy Programme

Control Arm: Usual Care

NO INTERVENTION

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.

Interventions

Thinking Healthy Programme 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.

Intervention Arm: Thinking Healthy Programme

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: The subject being studied is perinatal depression i.e. women in pregnancy and postnatal period.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Transcultural Psychosocial Organization Nepal: lead
• University of Liverpool: collaborator

Study Sites (1)

Transcultural Psychosocial Organization Nepal

Kathmandu, Bagmati, 44616, Nepal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The health facility is the unit of randomization. Altogether 4 health facilities will be selected for the study, where two health facilities will be allocated to each arm. The female community health volunteers (FCHVs) from the health facilities in the intervention arm will receive 10 days training on detection of perinatal depression and THP whilst the FCHVs from control arm will receive 3 days training on detection, psychoeducation, and referral.

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 26, 2022
• Study Start: November 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)