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| Name | Class |
|---|---|
| Jimma University | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prenatal Depression Symptoms | 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. | The primary outcome will be assessed immediately after the intervention is done; after eight weeks of the initiation of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Better Mental Health Related Quality of Life | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of maternal postpartum depression | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bekelu Teka Worku, Master of Public Health (MPH) | Contact | +251945031001 | bekelut23@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Bonnechere, PhD | Hasselt University | Principal Investigator |
| Misra Abdulahi, PhD | Jimma University | Principal Investigator |
| Demissew Amenu Sori, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jimma City in the Southwestern part of Ethiopia, 353 km away from the capital city, Addis Ababa. | Jimma | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39948517 | Background | 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. | |
| Background | 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 trial. Comprehensive Psychiatry. 2023;122:152375. 3. Min W, Jiang C, Li Z, Wang Z. The effect of mindfulness-based interventions during pregnancy on postpartum mental health: a meta-analysis. J Affect Disord. 2023;331:452-60. 22. Marlatt GA. Buddhist philosophy and the treatment of addictive behavior. Cogn Behav Pract. 2002;9(1):44-50. 4. Kabat-Zinn J. Mindfulness-based stress reduction (MBSR). Constructivism in the human sciences. 2003;8(2):73. |
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The data will be published in aggregate form without any information that could identify individual participants. If additional information is requested by other researchers, I may share the data in an anonymized format, and only when its use serves the advancement of scientific knowledge and aligns with the best interests of the study participants.
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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.
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Data collectors Participants in the control arm
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| Mental Health Related Quality of Life will be evaluated immediately after intervention (After eight weeks). |
| Symptoms of maternal postpartum depression will be measured at the ninth week from initiation of intervention. |
| Symptoms of paternal postpartum depression | 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. | Symptoms of paternal postpartum depression will be measured at the ninth week from initiation of intervention. |
| Neonatal birth outcome | Neonatal birth outcome will be assessed using a developed tool. | Neonatal birth outcome will be assessed at the ninth week from initiation of intervention. |
| Jimma University |
| Principal Investigator |