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

December 29, 2025 updated by: Zeynep Şimşek, Istanbul Bilgi University

Postpartum Depression Prevention Program in Disaster-Affected Regions

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Antakya
      • Hatay, Antakya, Turkey (Türkiye)
        • Narlıca 2 No'lu Family Physician Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Postpartum women aged 18 years or older

Having an infant younger than 60 days at the time of enrollment

Living in earthquake-affected regions of Türkiye

Receiving routine postpartum follow-up through primary health care services

Able to communicate in Turkish

Provided written informed consent

Exclusion Criteria:

History of a diagnosed psychiatric disorder prior to the current postpartum period

Severe medical conditions requiring specialized care

Cognitive impairment or any con

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trauma-Informed Postpartum Depression Prevention Program
Participants in this arm received a trauma-informed postpartum depression prevention program developed by the research team. The program was informed by findings from an initial qualitative phase using interpretative phenomenological analysis and was integrated into routine primary health care services in earthquake-affected regions. The intervention focused on early identification of psychological distress, psychoeducation, emotional support, strengthening coping skills, and enhancing social support.
This 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.
No Intervention: No Intervention / Usual Care
Participants in this arm received usual postpartum care provided through routine primary health care services without a structured trauma-informed mental health prevention component.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Depressive Symptoms
Time Frame: Baseline and at infant age 6 months.
Postpartum depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item self-report instrument widely used for screening depressive symptoms during the postpartum period. Higher scores indicate greater severity of depressive symptoms. The primary outcome was the change in EPDS scores from baseline to six months post-intervention.
Baseline and at infant age 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress
Time Frame: Baseline and at infant age 6 months.
Perceived stress was assessed using a self-report item asking participants how often they felt stressed during the past week, rated on a five-point scale ranging from "never" to "very often." Higher scores indicate higher perceived stress levels.
Baseline and at infant age 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping Perception
Time Frame: Baseline and at infant age 6 months.
Coping perception was assessed using a self-report item evaluating how often participants felt unable to cope with their problems during the past week, rated on a five-point Likert-type scale. Higher scores reflect stronger perceived coping ability.
Baseline and at infant age 6 months.
Perceived social support
Time Frame: Baseline and at infant age 6 months.
Perceived social support was assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), which measures perceived support from family, friends, and a significant other. Higher scores indicate greater perceived social support.
Baseline and at infant age 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Manuscript under peer review.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • BAP-2023.02.002
  • TUBİTAK424K188 (Other Grant/Funding Number: Scientific Research Projects Unit (BAP) of İstanbul Bilgi University and Scientific and Technological Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The dataset includes sensitive mental health information collected from postpartum women living in disaster-affected regions, and data sharing is restricted due to ethical and confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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