Clinical trial NCT05393479: "Thinking Healthy Programme" for Perinatal Depression in Nepal
Official title: Feasibility, Acceptability, Appropriateness, and Preliminary Effectiveness of "Thinking Healthy Programme" for Perinatal Depression in Nepal: A Pilot Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perinatal Depression
Keywords: perinatal depression
psychological intervention
nonspecialist
low and middle income countries
pilot cluster randomized control trial
Lead sponsor: Transcultural Psychosocial Organization Nepal
Sponsor class: OTHER
Collaborators: name: University of Liverpool
First posted: 2022-05-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Female Community Health Volunteers' clinical skills to provide psychological support
timeFrame: From pre training to immediate post training
measure: Qualitative Information: Feasibility from service providers' perspective
timeFrame: Month 18
measure: Qualitative Information: Feasibility from service users' perspective
timeFrame: 3 months postnatal
measure: Qualitative Information: Acceptability from service providers' perspective
timeFrame: Month 18
measure: Qualitative Information: Acceptability of of Thinking Healthy Programme from service users' perspective
timeFrame: 3 months postnatal
measure: Qualitative Information: Appropriateness of Thinking Healthy Programme from service providers' perspective
timeFrame: Month 18
measure: Qualitative Information: Appropriateness of Thinking Healthy Programme from service users' perspective
timeFrame: 3 months postnatal
Secondary outcomes:
measure: Changes in Patient Health Questionnaire-9+1
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Changes in Generalized Anxiety Disorder Scale
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Changes in World Health Organization's Disability Assessment Schedule
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Changes in Alcohol Use Disorder Identification Test
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Changes in Internalized Stigma of Mental Illness
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Changes in Multidimensional Scale of Perceived Social Support
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Suicide Assessment
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Antenatal care attendance
timeFrame: Baseline (M0), 2 months after baseline (M2)
measure: Domestic violence
timeFrame: Baseline (M0), 2 months after baseline (M2), 3 months postnatal (M4-M8)
measure: Postnatal care attendance
timeFrame: 3 months postnatal (M4-M8)
measure: Exclusive breastfeeding
timeFrame: 3 months postnatal (M4-M8)
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Transcultural Psychosocial Organization Nepal
state: Bagmati
Study officials:
References: