Prenatal DepressionNCT07151781
Technology Supported Mindfulness for Prenatal Depression and Mental Health-related Quality of Life in a Resource-Limited Environment
A study testing Video-guided Mindfulness Exercise in people with Prenatal Depression and Mental Health Related Quality of Life, run by Bekelu Teka Worku at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Prenatal Depression, Mental Health Related Quality of Life, Maternal Postpartum Depression
- What is being tested?
- Video-guided Mindfulness Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Nov 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site
Jimma City in the Southwestern part of Ethiopia, 353 km away from the capital city, Addis Ababa.
Jimma
Bekelu Teka Worku, Master of Public Health (MPH), +251945031001, bekelut23@gmail.com
About this study
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
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
- Being tested
- Video-guided Mindfulness Exercise
- Keywords
- mHealth, mindfulness, prenatal depression, randomized controlled trial, health technology, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-guided Mindfulness ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Video-guided Mindfulness Exercise |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome will be assessed immediately after the intervention is done; after eight weeks of the initiation of the intervention.
Secondary outcomes (1)
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.
Measured: Mental Health Related Quality of Life will be evaluated immediately after intervention (After eight weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prenatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bekelu Teka Worku
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University
- Responsible party
- Sponsor-investigator, Bekelu Teka Worku, Jimma University
- Investigators
- Bruno Bonnechere, PhD, Principal investigator, Hasselt UniversityMisra Abdulahi, PhD, Principal investigator, Jimma UniversityDemissew Amenu Sori, PhD, Principal investigator, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151781
- Sponsor's protocol ID
- JUIH/IRB/425/24
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 399485171. 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07151781
- Acronym / sponsor ID
- JUIH/IRB/425/24
- Conditions
- Prenatal Depression, Mental Health Related Quality of Life, Maternal Postpartum Depression, Paternal Postpartum Depression
- Keywords
- mHealth, mindfulness, prenatal depression, randomized controlled trial, health technology, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bekelu Teka WorkuUniversity, hospital or other
- Collaborators
- Jimma University
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Video-guided Mindfulness ExerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-guided Mindfulness ExerciseMindfulness 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. | Other | Intervention arm |
Primary outcome
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.
1 secondary outcome
Better Mental Health Related Quality of Life
Time frame: Mental Health Related Quality of Life will be evaluated immediately after intervention (After eight weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 39948517Worku 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.
- Background1. 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno Bonnechere, PhD principal investigator
Hasselt University
Misra Abdulahi, PhD principal investigator
Jimma University
Demissew Amenu Sori, PhD principal investigator
Jimma University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-guided Mindfulness Exercise in people with Prenatal Depression and Mental Health Related Quality of Life, run by Bekelu Teka Worku at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bekelu Teka Worku, Master of Public Health (MPH) (+251945031001, bekelut23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07151781, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.