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NCT Number: NCT07151781

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

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.

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Key information

Conditions

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

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Jimma, Ethiopia

Location contact

Bekelu Teka Worku, Master of Public Health (MPH)

CONTACT

[email protected]

+251945031001

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Video-guided Mindfulness Exercise

Other

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.

Primary outcomes

  1. 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.

    The symptoms of prenatal depression will be measured using the Edinburgh Postnatal Depression Scale. The EPDS is a widely validated 10-item self-report questionnaire designed to screen depressive symptoms primarily in the postnatal period and later extended for prenatal period depression symptoms. The study participants will be asked to report their relevant rating scale out of the available four response options with the EPDS. They will be asked about their experience of the symptoms over the past seven days. The higher score, which is three, indicates greater levels of depressive symptoms, and a zero score shows the absence of the symptoms. The maximum total score in EPDS is 30, where a cut-off score of ≥13 in clinical and research settings is used to indicate positive screened for PND.

Secondary outcomes

  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).

    The Mental Health Related Quality of Life (MHRQoL) will be assessed using the Mental Health Quality of Life-7 Dimensions (MHQoL-7D) questionnaire. The MHQoL-7D helps to evaluate seven key dimensions of mental health and well-being. The seven dimensions include "self-image, independence, mood, relationships, daily activities, physical health, and future outlook" of the individuals. This tool contains seven questions with a five-point Likert scale and measures feelings of the individual over the day. The score in MHQoL-7D ranges from a minimum of 0 to a maximum of 21, with the lower score indicating poor MHRQoL.

Other outcomes

  1. Symptoms of maternal postpartum depression

    Time frame: Symptoms of maternal postpartum depression will be measured at the ninth week from initiation of intervention.

    The symptoms of maternal postpartum depression will be measured using the Edinburgh Postnatal Depression Scale. The EPDS is a widely validated 10-item self-report questionnaire designed to screen depressive symptoms primarily in the postnatal period and later extended for prenatal period depression symptoms. The study participants will be asked to report their relevant rating scale out of the available four response options with the EPDS. They will be asked about their experience of the symptoms over the past seven days. The higher score, which is three, indicates greater levels of depressive symptoms, and a zero score shows the absence of the symptoms. The maximum total score in EPDS is 30, where a cut-off score of ≥13 in clinical and research settings is used to indicate positive screened for postpartum depression.

  2. Symptoms of paternal postpartum depression

    Time frame: Symptoms of paternal postpartum depression will be measured at the ninth week from initiation of intervention.

    The symptoms of paternal postpartum depression will be measured using the Edinburgh Postnatal Depression Scale. The EPDS is a widely validated 10-item self-report questionnaire designed to screen depressive symptoms primarily in the postnatal period and later extended for prenatal period depression symptoms. The study participants will be asked to report their relevant rating scale out of the available four response options with the EPDS. They will be asked about their experience of the symptoms over the past seven days. The higher score, which is three, indicates greater levels of depressive symptoms, and a zero score shows the absence of the symptoms. The maximum total score in EPDS is 30, where a cut-off score of ≥13 in clinical and research settings is used to indicate positive screened for postpartum depression.

  3. Neonatal birth outcome

    Time frame: Neonatal birth outcome will be assessed at the ninth week from initiation of intervention.

    Neonatal birth outcome will be assessed using a developed tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Bekelu Teka Worku, Master of Public Health (MPH)

CONTACT

[email protected]

+251945031001

Sponsors and collaborators

Lead sponsor

Bekelu Teka Worku

Other

Collaborators

  • Jimma University

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

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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