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Completed

NCT Number: NCT07545551

Digital Perinatal Bereavement Support Program for Women After Pregnancy Loss

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Institute of Health Sciences

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

Supportive Care

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DPBSP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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