NCT07329270

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

postpartum depression | trauma-informed care | disaster response | maternal mental health | primary health care | resilience | Türkiye earthquakes

Outcome Measures

Primary Outcomes (1)

  • Postpartum Depressive Symptoms

    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 Outcomes (1)

  • Perceived Stress

    Baseline and at infant age 6 months.

Other Outcomes (2)

  • Coping Perception

    Baseline and at infant age 6 months.

  • Perceived social support

    Baseline and at infant age 6 months.

Study Arms (2)

Trauma-Informed Postpartum Depression Prevention Program

EXPERIMENTAL

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.

Behavioral: Trauma-Informed Preventive Intervention

No Intervention / Usual Care

NO INTERVENTION

Participants in this arm received usual postpartum care provided through routine primary health care services without a structured trauma-informed mental health prevention component.

Interventions

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.

Trauma-Informed Postpartum Depression Prevention Program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of a diagnosed psychiatric disorder prior to the current postpartum period
  • Severe medical conditions requiring specialized care
  • Cognitive impairment or any con

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narlıca 2 No'lu Family Physician Center

Hatay, Antakya, Turkey (Türkiye)

Location

Related Publications (1)

  • Manuscript under peer review.

    BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were masked to group assignment. Due to the nature of the psychosocial intervention, care providers were not masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were assigned in parallel to either a trauma-informed postpartum depression prevention program or to usual postpartum care. The intervention was developed using findings from an initial qualitative phase and evaluated using an experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Public Health and Social Work / Dean, Faculty of Health Sciences

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 9, 2026

Study Start

November 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 30, 2025

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations