Antenatal DepressionNCT06685484
Feasibility of Modified Mindfulness Training on Antenatal Depression and Perceived Stress in Pregnant Women With Male Child Preference
A study testing Modified Mindfulness Training Program (MMTP) in people with Antenatal Depression, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This study will assess the feasibility of a modified mindfulness training intervention aimed at reducing antenatal depression and perceived stress in pregnant women with male child preference. The findings aim to support mental health interventions in maternity care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antenatal Depression
- What is being tested?
- Modified Mindfulness Training Program (MMTP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2024to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women in the first and second trimester
- Score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS)
Who cannot join
- Psychiatric illness history, use of psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Feasibility of Modified Mindfulness Training Program (MMTP) to Address Antenatal Depression and Perceived Stress Among Pregnant Women Exhibiting Male Child Preference
This study will assess the feasibility of a modified mindfulness training intervention aimed at reducing antenatal depression and perceived stress in pregnant women with male child preference. The findings aim to support mental health interventions in maternity care.
Read the detailed description
Utilizing the ADAPT-ITT framework, this study will tailor mindfulness-based interventions to address unique cultural stressors, particularly those affecting maternal mental health due to male child preference.
- Conditions
- Antenatal Depression
- Being tested
- Modified Mindfulness Training Program (MMTP)
- Keywords
- Mindfulness training, Antenatal depression, Male Child preference, Perceived Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Mindfulness Training Program (MMTP)Behavioural
The intervention, designed as a Modified Mindfulness Training Program (MMTP), aims to reduce antenatal depression and perceived stress among pregnant women, especially those with a preference for a male child. This program is adapted to address culturally specific stressors relevant to these women, promoting mental health and resilience during pregnancy.
The intervention is based on Nola Pender's Health Promotion Model and structured using the ADAPT-ITT framework, which includes Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, and Testing phases. This phased approach ensures cultural relevance and feasibility within the target population of pregnant women in Pakistan.
Duration and Frequency: The intervention consists of six weekly sessions, each lasting two hours, held in a serene, controlled environment within a seminar room at Sindh Govt. Qatar Hospital, Karachi.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receives Modified Mindfulness Training Program (MMTP), adapted to address cultural stressors and reduce antenatal depression. Receives: Behavioral: Modified Mindfulness Training Program (MMTP) |
| Control Group | No intervention | Receives standard antenatal care without mindfulness intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Antenatal Depression
This outcome specifically measures changes in antenatal depression levels among pregnant women with male child preference. Depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), with scores taken at baseline, immediately post-intervention, and at the one-month follow-up. A reduction in EPDS scores from baseline to follow-up indicates improvement in mental health.
Measured: Baseline assessment, immediately post-intervention (six weeks), and one-month follow-up.
Reduction in Perceived Stress
This outcome focuses on changes in perceived stress levels using the Perceived Stress Scale (PSS-10). Scores will be taken at baseline, post-intervention, and one-month follow-up to measure the effectiveness of the Modified Mindfulness Training Program (MMTP) on stress reduction.
Measured: Immediately post-intervention (after six weeks)
Participant Satisfaction with the Modified Mindfulness Training Program
This outcome measures participant satisfaction levels with the Modified Mindfulness Training Program intervention, gauging ease of use, cultural appropriateness, and overall program relevance. Data will be gathered using a post-intervention feedback survey with Likert-scale responses.
Measured: Immediately post-intervention (after six weeks)
Acceptability of the Modified Mindfulness Training Program in a Clinical Setting
This outcome evaluates the acceptability of the Modified Mindfulness Training Program intervention in a clinical setting, using qualitative data from open-ended interviews. The qualitative feedback will indicate cultural appropriateness and feasibility of implementation.
Measured: Immediately post-intervention (after six weeks)
Follow-Up Effects on Coping Skills
This outcome assesses sustained improvements in coping skills for managing antenatal stress post-intervention, measured through scores on the PSS-10 at one-month follow-up.
Measured: One-month follow-up after intervention completion
Follow-Up Effects on Resilience
This outcome focuses on the resilience of participants in managing antenatal depression, measured through EPDS scores and supported by qualitative feedback at one-month follow-up.
Measured: One-month follow-up after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Nov 2024
- Primary completion31 Mar 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Antenatal 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 feasibility trial using the ADAPT-ITT framework will randomly assign participants to two groups.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Badil, Principal investigator, Institute of Nursing Sciences, Khyber Medical University PeshawarDr Najma Naz, PhD, Principal investigator, Institute of Nursing, Khyber Medical University PeshawarDr Khalid Rahman, PhD, Principal investigator, Institute of Public Health and Social Science, Khyber Medical University Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685484
- Sponsor's protocol ID
- KMU/DIR/CTU/2024/009
- Status last verified
- Apr 2025
- First submitted
- 5 Nov 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD sharing plan includes de-identified data for the primary and secondary outcomes, specifically related to antenatal depression and perceived stress scores (PSS-10 and EPDS) before and after the intervention, as well as demographic information that may influence outcomes (e.g., age, pregnancy stage, gender preference). The data will be shared to facilitate replication studies, meta-analyses, and further research on the Modified Mindfulness Training Program's effects on antenatal mental health.
Publications
Ayano G, Tesfaw G, Shumet S. Prevalence and determinants of antenatal depression in Ethiopia: A systematic review and meta-analysis. PLoS One. 2019 Feb 19;14(2):e0211764. doi: 10.1371/journal.pone.0211764. eCollection 2019.
PubMed 30779765Guo J, Zheng A, He J, Ai M, Gan Y, Zhang Q, Chen L, Liang S, Yu X, Kuang L. The prevalence of and factors associated with antenatal depression among all pregnant women first attending antenatal care: a cross-sectional study in a comprehensive teaching hospital. BMC Pregnancy Childbirth. 2021 Oct 26;21(1):713. doi: 10.1186/s12884-021-04090-z.
PubMed 34702205Yin X, Sun N, Jiang N, Xu X, Gan Y, Zhang J, Qiu L, Yang C, Shi X, Chang J, Gong Y. Prevalence and associated factors of antenatal depression: Systematic reviews and meta-analyses. Clin Psychol Rev. 2021 Feb;83:101932. doi: 10.1016/j.cpr.2020.101932. Epub 2020 Oct 25.
PubMed 33176244Sikander S, Ahmad I, Bates LM, Gallis J, Hagaman A, O'Donnell K, Turner EL, Zaidi A, Rahman A, Maselko J. Cohort Profile: Perinatal depression and child socioemotional development ; the Bachpan cohort study from rural Pakistan. BMJ Open. 2019 May 5;9(5):e025644. doi: 10.1136/bmjopen-2018-025644.
PubMed 31061029Tesfaye Y, Agenagnew L. Antenatal Depression and Associated Factors among Pregnant Women Attending Antenatal Care Service in Kochi Health Center, Jimma Town, Ethiopia. J Pregnancy. 2021 Feb 8;2021:5047432. doi: 10.1155/2021/5047432. eCollection 2021.
PubMed 33628509
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Feasibility of Modified Mindfulness Training Program (MMTP) to Address Antenatal Depression and Perceived Stress Among Pregnant Women Exhibiting Male Child Preference
- ClinicalTrials.gov ID
- NCT06685484
- Acronym / sponsor ID
- KMU/DIR/CTU/2024/009
- Conditions
- Antenatal Depression
- Keywords
- Mindfulness training, Antenatal depression, Male Child preference, Perceived Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 12 Nov 2024 (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.
This study will assess the feasibility of a modified mindfulness training intervention aimed at reducing antenatal depression and perceived stress in pregnant women with male child preference. The findings aim to support mental health interventions in maternity care.
Detailed description
Utilizing the ADAPT-ITT framework, this study will tailor mindfulness-based interventions to address unique cultural stressors, particularly those affecting maternal mental health due to male child preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A feasibility trial using the ADAPT-ITT framework will randomly assign participants to two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Modified Mindfulness Training Program (MMTP)Receives Modified Mindfulness Training Program (MMTP), adapted to address cultural stressors and reduce antenatal depression. |
| Control Group | No intervention | –Receives standard antenatal care without mindfulness intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women in the first and second trimester
- Score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS)
Key exclusion criteria (1 listed)
- Psychiatric illness history, use of psychiatric medication
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 |
|---|---|---|
| Modified Mindfulness Training Program (MMTP)The intervention, designed as a Modified Mindfulness Training Program (MMTP), aims to reduce antenatal depression and perceived stress among pregnant women, especially those with a preference for a male child. This program is adapted to address culturally specific stressors relevant to these women, promoting mental health and resilience during pregnancy. The intervention is based on Nola Pender's Health Promotion Model and structured using the ADAPT-ITT framework, which includes Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, and Testing phases. This phased approach ensures cultural relevance and feasibility within the target population of pregnant women in Pakistan. Duration and Frequency: The intervention consists of six weekly sessions, each lasting two hours, held in a serene, controlled environment within a seminar room at Sindh Govt. Qatar Hospital, Karachi. | Behavioural | Intervention Group |
Primary outcome
Reduction in Antenatal Depression
Time frame: Baseline assessment, immediately post-intervention (six weeks), and one-month follow-up.
This outcome specifically measures changes in antenatal depression levels among pregnant women with male child preference. Depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), with scores taken at baseline, immediately post-intervention, and at the one-month follow-up. A reduction in EPDS scores from baseline to follow-up indicates improvement in mental health.
Reduction in Perceived Stress
Time frame: Immediately post-intervention (after six weeks)
This outcome focuses on changes in perceived stress levels using the Perceived Stress Scale (PSS-10). Scores will be taken at baseline, post-intervention, and one-month follow-up to measure the effectiveness of the Modified Mindfulness Training Program (MMTP) on stress reduction.
Participant Satisfaction with the Modified Mindfulness Training Program
Time frame: Immediately post-intervention (after six weeks)
This outcome measures participant satisfaction levels with the Modified Mindfulness Training Program intervention, gauging ease of use, cultural appropriateness, and overall program relevance. Data will be gathered using a post-intervention feedback survey with Likert-scale responses.
Acceptability of the Modified Mindfulness Training Program in a Clinical Setting
Time frame: Immediately post-intervention (after six weeks)
This outcome evaluates the acceptability of the Modified Mindfulness Training Program intervention in a clinical setting, using qualitative data from open-ended interviews. The qualitative feedback will indicate cultural appropriateness and feasibility of implementation.
Follow-Up Effects on Coping Skills
Time frame: One-month follow-up after intervention completion
This outcome assesses sustained improvements in coping skills for managing antenatal stress post-intervention, measured through scores on the PSS-10 at one-month follow-up.
Follow-Up Effects on Resilience
Time frame: One-month follow-up after intervention completion
This outcome focuses on the resilience of participants in managing antenatal depression, measured through EPDS scores and supported by qualitative feedback at one-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Background: PubMed 30779765Ayano G, Tesfaw G, Shumet S. Prevalence and determinants of antenatal depression in Ethiopia: A systematic review and meta-analysis. PLoS One. 2019 Feb 19;14(2):e0211764. doi: 10.1371/journal.pone.0211764. eCollection 2019.
- Background: PubMed 34702205Guo J, Zheng A, He J, Ai M, Gan Y, Zhang Q, Chen L, Liang S, Yu X, Kuang L. The prevalence of and factors associated with antenatal depression among all pregnant women first attending antenatal care: a cross-sectional study in a comprehensive teaching hospital. BMC Pregnancy Childbirth. 2021 Oct 26;21(1):713. doi: 10.1186/s12884-021-04090-z.
- Background: PubMed 33176244Yin X, Sun N, Jiang N, Xu X, Gan Y, Zhang J, Qiu L, Yang C, Shi X, Chang J, Gong Y. Prevalence and associated factors of antenatal depression: Systematic reviews and meta-analyses. Clin Psychol Rev. 2021 Feb;83:101932. doi: 10.1016/j.cpr.2020.101932. Epub 2020 Oct 25.
- Background: PubMed 31061029Sikander S, Ahmad I, Bates LM, Gallis J, Hagaman A, O'Donnell K, Turner EL, Zaidi A, Rahman A, Maselko J. Cohort Profile: Perinatal depression and child socioemotional development ; the Bachpan cohort study from rural Pakistan. BMJ Open. 2019 May 5;9(5):e025644. doi: 10.1136/bmjopen-2018-025644.
- Background: PubMed 33628509Tesfaye Y, Agenagnew L. Antenatal Depression and Associated Factors among Pregnant Women Attending Antenatal Care Service in Kochi Health Center, Jimma Town, Ethiopia. J Pregnancy. 2021 Feb 8;2021:5047432. doi: 10.1155/2021/5047432. eCollection 2021.
- Individual participant dataSharing planned: Yes. The IPD sharing plan includes de-identified data for the primary and secondary outcomes, specifically related to antenatal depression and perceived stress scores (PSS-10 and EPDS) before and after the intervention, as well as demographic information that may influence outcomes (e.g., age, pregnancy stage, gender preference). The data will be shared to facilitate replication studies, meta-analyses, and further research on the Modified Mindfulness Training Program's effects on antenatal mental health.
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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. This study is not recruiting at the moment.
Dr Badil principal investigator
Institute of Nursing Sciences, Khyber Medical University Peshawar
Dr Najma Naz, PhD principal investigator
Institute of Nursing, Khyber Medical University Peshawar
Dr Khalid Rahman, PhD principal investigator
Institute of Public Health and Social Science, Khyber Medical University Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Mindfulness Training Program (MMTP) in people with Antenatal Depression, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Antenatal Depression (time frame: Baseline assessment, immediately post-intervention (six weeks), and one-month follow-up.). The study lists 6 primary outcomes in all. 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 NCT06685484, which also lists 5 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 29 Apr 2025.