Feasibility of Modified Mindfulness Training on Antenatal Depression and Perceived Stress in Pregnant Women With Male Child Preference

Not Applicable

Completed

• Conditions: Antenatal Depression

• Registration Number: NCT06685484
• Lead Sponsor: Khyber Medical University Peshawar

Brief 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.

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 Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Primary Completion: 2025-03-31
• Status Verified: 2025-04
• Study Completion: 2025-04-23
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Pregnant women in the first and second trimester
• Score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS)

Exclusion Criteria

• Psychiatric illness history, use of psychiatric medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Antenatal Depression	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	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	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	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	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	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.

Trial Locations

Locations (1)

Qatar Hospital; 🇵🇰 Karachi, Sindh, Pakistan