An interventional study of Modified Mindfulness Training Program (MMTP) in Antenatal Depression, sponsored by Khyber Medical University Peshawar. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 84 is close to the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Receives Modified Mindfulness Training Program (MMTP), adapted to address cultural stressors and reduce antenatal depression.
Behavioral: Modified Mindfulness Training Program (MMTP)
Receives standard antenatal care without mindfulness intervention.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One-month follow-up after intervention completion
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Khyber Medical University Peshawar