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Trials / Completed

CompletedNCT07329270

A Trauma-Informed Primary Health Care Intervention to Prevent Postpartum Depression After Disaster

Postpartum Depression Prevention Program in Disaster-Affected Regions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
106 (actual)
Sponsor
Istanbul Bilgi University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

Postpartum depression is a common mental health problem that can affect women after childbirth and may have long-lasting consequences for both mothers and infants. The risk of postpartum depression is substantially higher in disaster-affected regions due to exposure to trauma, loss, displacement, disruption of health services, and ongoing psychosocial stressors. This study aimed to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye using a sequential mixed-methods design. In the first phase, the program was developed based on qualitative findings obtained through in-depth interviews with postpartum women. In the second phase, the effectiveness of the newly developed program was tested using an experimental design. During the qualitative phase, in-depth interviews were conducted with 24 postpartum women, and data were analyzed using interpretative phenomenological analysis (IPA) to explore women's lived experiences, perceived needs, and priorities related to mental health and psychosocial support after childbirth in a disaster context. The findings from this phase informed the content, structure, and delivery of the trauma-informed prevention program. In the quantitative phase, the program was evaluated through a randomized controlled trial. Eligible postpartum women were randomly assigned either to the trauma-informed prevention program or to a comparison group receiving usual primary health care services. Postpartum depressive symptoms were assessed using validated measures. The primary objective of the study was to evaluate the effectiveness of the trauma-informed program in reducing postpartum depressive symptoms. The findings are expected to contribute to evidence-based, trauma-informed approaches for preventing postpartum depression in disaster-affected settings.

Detailed description

Women living in disaster-affected regions face increased vulnerability to postpartum depression due to exposure to traumatic events, loss of social and material resources, disruptions in health care delivery, and prolonged uncertainty. Addressing postpartum mental health in such contexts requires interventions that are both evidence-based and responsive to women's lived experiences. This study employed a sequential mixed-methods design to develop and evaluate a trauma-informed postpartum depression prevention program for women living in earthquake-affected regions of Türkiye. The study consisted of two consecutive phases: a qualitative program development phase and a quantitative experimental evaluation phase. In the first phase, the trauma-informed postpartum depression prevention program was developed by the research team based on qualitative data collected from 24 postpartum women. In-depth, semi-structured interviews were conducted to explore participants' lived experiences of the postpartum period in a disaster context, perceived psychosocial needs, sources of distress and support, and expectations from health care services. The qualitative data were analyzed using interpretative phenomenological analysis (IPA), allowing for an in-depth understanding of participants' subjective experiences and meaning-making processes. The findings from this phase directly informed the content, focus, and delivery strategies of the intervention. In the second phase, the effectiveness of the newly developed program was evaluated using an experimental design. Eligible postpartum women were recruited through primary health care services and randomly assigned to either the intervention group, which received the trauma-informed postpartum depression prevention program, or a comparison group receiving usual postpartum care. The intervention was delivered within routine primary health care settings by trained health care professionals. The primary outcome of the study was postpartum depressive symptoms, assessed using validated screening instruments at predefined follow-up points. Secondary outcomes included measures of perceived social support, stress and coping perception. Data collection and outcome assessments were conducted in accordance with the study protocol. By combining qualitative insights from postpartum women with rigorous experimental testing, this study aimed to generate robust evidence on the development and effectiveness of trauma-informed preventive interventions for postpartum depression in disaster-affected settings. The findings are intended to inform maternal mental health practice, program development, and public health policy in disaster and post-disaster contexts.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTrauma-Informed Preventive InterventionThis is a newly developed trauma-informed postpartum depression prevention program designed for women living in earthquake-affected regions. The program was developed by the research team based on qualitative findings from in-depth interviews with postpartum women analyzed using interpretative phenomenological analysis. It was delivered within primary health care settings by trained health care professionals and included psychoeducation, emotional support, coping skills enhancement, and facilitation of social support and referral when needed.

Timeline

Start date
2024-11-01
Primary completion
2025-07-01
Completion
2025-07-30
First posted
2026-01-09
Last updated
2026-01-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07329270. Inclusion in this directory is not an endorsement.