Addressing Perinatal Depression in Deprived Areas of Istanbul, Turkey
NCT04819711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2022-08-26
Summary
In Turkey, the prevalence rate of perinatal depression has been estimated between 20%-40%, reflecting the global average of 25%. Untreated perinatal depression is of concern not only because of its effect on maternal health but also from the effect that impaired maternal role fulfilment has on the mother-infant bonding and child care and the long-term impact on the infant's physical and cognitive development. Thinking Healthy Programme (THP) is an evidence-based intervention incorporated into the World Health Organization's flagship Mental Health Gap Action Programme, tailored to the perinatal period that has been shown to be effective for depressed or stressed mothers. Turkey prioritize antenatal care, and this provides an opportunity to integrate mental health care into an existing antenatal care programme. Public hospitals operate 'antenatal pregnancy schools' where women are invited to attend 5 weekly group sessions that incorporate education about pregnancy and newborn care. We have developed an on-line group version of the Thinking Healthy Programme which has been designed to be integrated into the routine on-line antenatal pregnancy classes. The intervention has been designed so it is suitable for all women (universal) rather than depressed mothers only (targeted).
The aim of this study is to pilot this adapted on-line group intervention in selected hospitals' pregnancy schools.
The study will be a two-arm pilot individual randomised controlled trial comparing the Thinking Healthy group intervention integrated into antenatal pregnancy school classes with antenatal pregnancy school classes alone. Our sample size of 60 pregnant women (that is 30 participants in each arm of the pilot trial), who are over 18 years old, between 12-30 weeks' gestation, and intend to attend all 5 sessions of the online antenatal classes. Participants in both arms will be assessed for depression and anxiety symptoms, levels of disability, quality of sleep, perceived social support, coping skills, and relationship with partner. All one hundred and twenty women will get a detailed assessment initially and 4-6 weeks after the intervention. Some of the study participants and antenatal nurses delivering these sessions will be approached for in-depth qualitative interviews to explore the acceptability, feasibility and perceptions of the study participants' receiving the intervention sessions.
Conditions
- Perinatal Depression
Interventions
- BEHAVIORAL
-
Thinking Healthy Programme
The Thinking Healthy Programme (THP) is an evidence-based intervention that is based on principles of cognitive behavioral therapy. It includes strategies that incorporate behavioral activation, active listening, collaboration with the family, guided discovery, and homework. The adapted THP consists of 5 integrated sessions. Session 1 introduces the programme and focuses on engagement of participants, introduction of THP, and breathing exercises. Session 2 focuses on psychoeducation and problem solving. Session 3 focuses on the mother's well-being and introduces activities such as physical exercises, good sleep practices and ensuring a balanced diet. Session 4 focuses on the mother's relationship with the unborn baby. Session 5 focuses on activating social support from family, friends and peers and provides closure of therapy.
Sponsors & Collaborators
- collaborator OTHER_GOV
-
Perran Boran
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-05
- Primary Completion
- 2021-10-20
- Completion
- 2021-11-11
Countries
- Turkey (Türkiye)
- United Kingdom
Study Locations
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