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

Official title

Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life: Research Protocol for Randomized Controlled Trial in a Resource-Limited Environment

Overview

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.

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 a

Primary outcome measures

• Prenatal Depression Symptoms [Time frame: The primary outcome will be assessed immediately after the intervention is done; after eight weeks of the initiation of the intervention.]

Secondary outcome measures (1)

• Better Mental Health Related Quality of Life [Time frame: Mental Health Related Quality of Life will be evaluated immediately after intervention (After eight weeks).]

Eligibility criteria

Inclusion criteria

• Pregnant women who lived in Jimma City for at least six months
• Women with a gestational age between 12 and 28 weeks,
• Women who scored EPDS ≥ 13,
• Willing to participate for eight consecutive weeks,
• Able to attend the health center three times per week and gave consent to be followed up by study supervisors and data collectors

Exclusion criteria

• Having been diagnosed with mental health disorders or eating disorders,
• Active substance use,
• EPDS item 10 score ≥1 or total EPDS score >19,
• Currently receiving pharmacological or psychotherapeutic treatment,
• Regularly practice meditation,
• Severely ill,
• Has active pregnancy-related complications that could interfere with attending the mindfulness exercise, or neurological conditions such as epilepsy or seizures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Ethiopia · 1 center

• Jimma City in the Southwestern part of Ethiopia, 353 km away from the capital city, Addis — Jimma

Publications

• Worku BT, Abdulahi M, Amenu D, Bonnechere B. Effect of technology-supported mindfulness-based interventions for maternal depression: a systematic review and meta-analysis with implementation perspectives for resource-limited settings. BMC Pregnancy Childbirth. 2025 Feb 13;25(1):155. doi: 10.1186/s12884-025-07286-9. PMID 39948517
• 1. Molenaar NM, Kamperman AM, Boyce P, Bergink V. Guidelines on treatment of perinatal depression with antidepressants: an international review. Australian & New Zealand Journal of Psychiatry. 2018;52(4):320-7. 2. Leng LL, Yin XC, Ng SM. Mindfulness-based intervention for clinical and subthreshold perinatal depression and anxiety: a systematic review and meta-analysis of randomized controlled tria

Identifiers

NCT: NCT07151781 · JUIH/IRB/425/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗