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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Online Prenatal Trial in Mindfulness Sleep Management

NCT04016428

Pregnancy Related Insomnia Depression

COMPLETED NA

Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum

NCT05137925

Psychological Distress Pregnancy Related Postpartum Blues +3 more

ACTIVE_NOT_RECRUITING NA

The Staying Well Study: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression

NCT02391870

Pregnancy Depression Postpartum Depression

COMPLETED NA

Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence

NCT02387424

Postpartum Depression Pregnancy Depression

COMPLETED NA

Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)

NCT03802734

Sleep Pregnancy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial (RCT) with a 1:1 allocation ratio will be used to compare a video-guided mindfulness intervention group with a standard care control group.

Study participants will be recruited at the community level. Pregnant women will be identified and registered by a team called "Gaachana", a local volunteer group working under the supervision of Health Extension Workers (HEWs). Screening for PND will be conducted using the Edinburgh Postnatal Depression Scale (EPDS) by trained data collectors until the required sample size is achieved. Eligible participants will be randomly assigned to either the intervention or control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Data collectors Participants in the control arm

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

The intervention arm will receive a video-guided mindfulness practice consisting of audio recordings (in two local languages: Afan Oromo and Amharic) combined with familiar natural environment visuals. The exercise instruction consists of three core mindfulness practices: (i) Focus the Mind: to cultivate present-moment attention and reduce cognitive rumination; (ii) Breath Awareness: to anchor attention and promote relaxation; and (iii) Basic Body Scan: to encourage non-judgmental awareness of bodily sensations to enhance their mind-body connection.

The intervention will be delivered face-to-face at the health centers using a smartphone-based video. The intervention is planned to be delivered regularly according to a standardized schedule for each of the women individually. Each session of the exercise can last for about 21-23 minutes. Hired Midwifery Nurses at each of the health centers will support the woman to start the exercise and follow her till the end of the sessions daily.

Group Type EXPERIMENTAL

Video-guided Mindfulness Exercise

Intervention Type 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.

Control group

The control group will continue with the routine maternal and other standard health care services as provided by the health centers in accordance with national maternal health guidelines. In Ethiopia, according to the National Antenatal Care Guideline 2022, each woman must visit the health facility for eight contacts. They are expected to screened for potentially recurring obstetric complications such as recurrent pregnancy loss, preterm labor, pre-eclampsia/eclampsia, gestational diabetes, congenital anomaly, puerperal psychosis, obstetric and gynecologic surgery, immunologic disorders, medical and mental health disorders, infectious diseases, physical disability and developmental disorders, nutritional history, social and personal history, current medication, and intimate partner violence. They receive counselling on the risk of pregnancy, contraception, micronutrient supplementation, weight gain monitoring, counselling on the increased risk to the fetus, and other related services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No