Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life in a Resource-Limited Environment

Summary

The goal of this clinical trial is to learn if a video-guided mindfulness intervention can improve prenatal depression symptoms, improve mental health-related quality of life, reduce the risk of maternal postpartum depression and paternal postpartum depression, and improve neonatal birth outcomes in a resource-constrained setting. This clinical trial will be conducted in pregnant women. The main questions it aims to answer are:

* Can video-guided mindfulness intervention be effective for prenatal depression treatment as compared to routine care?
* Is there a dose-response relationship between the length of a video-guided mindfulness intervention and a reduction in prenatal depression symptoms?
* Does a video-guided mindfulness intervention improve mental health-related quality of life more effectively than routine care?
* What is the impact of intervention duration on the effectiveness of a video-guided mindfulness intervention for improving mental health-related quality of life?
* Can a video-guided mindfulness intervention during pregnancy lead to improved neonatal birth outcomes compared to standard care?
* Can a video-guided mindfulness intervention during pregnancy reduce the risk of developing prenatal depression compared to routine care?
* Can the treatment of maternal prenatal depression through a video-guided mindfulness intervention reduce the risk of paternal postpartum depression? Researchers will compare the intervention group with a group of pregnant women who screen positive for prenatal depression but continue to receive only routine antenatal care, in order to evaluate differences in prenatal depression symptoms, improvements in mental health-related quality of life, reductions in the risk of maternal and paternal postpartum depression, and improvements in neonatal birth outcomes.

Participants (the intervention group) will receive a video-guided mindfulness intervention that they will listen to for eight weeks at their nearest health center three times a week.

Conditions

• Prenatal Depression
• Mental Health Related Quality of Life
• Maternal Postpartum Depression
• Paternal Postpartum Depression

Interventions

OTHER

Video-guided Mindfulness Exercise

Mindfulness interventions are emerging as effective, low-risk approaches to managing depression and enhancing emotional and maternal well-being in pregnant women. Rooted in ancient meditative practices that originated from Buddhist religion and traditions and adapted for clinical use, mindfulness intervention cultivates present-moment awareness and nonjudgmental acceptance of thoughts, emotions, and bodily sensations. Mostly, mindfulness interventions include elements such as mindful breathing and body scanning and have shown effectiveness in reducing depressive symptoms and enhancing emotional regulation. It is the ability to maintain attention to an immediate experience with a sense of adopting an open and accepting attitude toward that experience. However, further research is important to evaluate its effectiveness across diverse sociodemographic and socioeconomic settings.

Sponsors & Collaborators

• Jimma University

  collaborator OTHER

• Bekelu Teka Worku

  lead OTHER

Principal Investigators

• Bruno Bonnechere, PhD · Hasselt University

• Misra Abdulahi, PhD · Jimma University

• Demissew Amenu Sori, PhD · Jimma University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2025-12-30

Completion

2025-12-31

Countries

• Ethiopia

Study Locations