Digital Perinatal Bereavement Support Program for Women After Pregnancy Loss (DPBSP)

April 16, 2026 updated by: Şengül Yaman Sözbir, Gazi University

THE EFFECT OF PERINATAL GRIEF COUNSELING PROVIDED VIA DIGITAL PLATFORM ON GRIEF AND POST-TRAUMATIC STRESS: A RANDOMIZED CONTROLLED STUDY

This study aims to evaluate the effectiveness of a digital perinatal bereavement support program designed for women who have experienced pregnancy loss. Perinatal loss is associated with significant psychological distress, including grief, depression, and anxiety, which may persist over time if not adequately addressed.

The intervention consists of a structured digital support program delivered over five weeks, focusing on emotional processing, coping strategies, and psychological resilience. Participants were assessed at baseline, immediately after the intervention, and during follow-up periods at 1 month, 3 months, and 6 months.

The primary objective is to determine whether the intervention improves psychological outcomes, including grief and depressive symptoms. The findings are expected to contribute to the development of accessible and scalable mental health support models for women experiencing perinatal loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Perinatal loss is a significant life event that can lead to long-term psychological consequences, including prolonged grief, depression, and anxiety. Despite the high prevalence of these outcomes, access to structured psychological support remains limited, particularly in scalable and accessible formats.

This study investigates the effectiveness of a digitally delivered perinatal bereavement support program developed to provide structured emotional and psychological support for women following pregnancy loss. The intervention was administered over a five-week period and included components targeting grief processing, emotional expression, and adaptive coping strategies.

Participants were evaluated at multiple time points, including baseline (pre-intervention), post-intervention, and follow-up assessments at 1 month, 3 months, and 6 months. Psychological outcomes were assessed using validated measurement tools.

The primary aim of the study is to assess changes in psychological outcomes over time and to determine the sustainability of intervention effects during the follow-up period. This study contributes to the growing body of evidence supporting digital mental health interventions and offers insights into scalable support mechanisms for perinatal bereavement.

Study Type

Interventional

Enrollment (Actual)

54

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

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye), 06000
        • Gazi University Institute of Health Sciences

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:

- Women aged 18 years and older who have experienced perinatal loss within the past two months; ability to read and write at a basic level; ability to speak and understand Turkish; access to a digital platform (internet-enabled device); and no history of previous live birth. Provision of informed consent.

Exclusion Criteria:

History of a previous perinatal loss; presence of any uncontrolled psychiatric disorder; presence of communication impairments (cognitive, auditory, or visual); experiencing another major grief event (e.g., divorce, death) within the past year; or receiving any psychosocial support within the past year.

-

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Participants received a structured supportive care program following perinatal loss. The intervention was delivered over a 5-week period and included psychological support aimed at reducing grief, anxiety, and depression.
Behavioral: Supportive Care
A structured supportive care program designed for women experiencing perinatal loss. The intervention was delivered over 5 weeks through a digital platform specifically developed for this study. It included regular psychological support sessions aimed at reducing grief, anxiety, and depressive symptoms. The program incorporated emotional support, coping strategies, and guided communication techniques.
No Intervention: control group
Participants received routine postpartum care without any additional structured supportive intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in grief levels
Time Frame: Baseline, 5 weeks (end of inversions), and 1,3, and 6 months follow up
Change in grief levels measured using a validated grief scalesamong women experiencing perinatal loss, comparing the intervention and control groups.
Baseline, 5 weeks (end of inversions), and 1,3, and 6 months follow up

Collaborators and Investigators

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

Sponsor

Gazi University

Collaborators

Gazi University Scientific Research Projects Unit (BAP) Project No: TDK-2026-10810

Investigators

  • Principal Investigator: Şengül YAMAN SÖZBİR, PhD, Gazi University
  • Study Chair: Büşra Özer, PhD Candidate, Gazi University

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)

April 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to ethical restrictions and the sensitive nature of psychological data collected from participants experiencing perinatal loss. Data confidentiality and participant privacy will be strictly maintained in accordance with institutional review board (IRB) approvals and applicable regulations.

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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