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

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.

Study Overview

• Status: Completed
• Conditions: Antenatal Depression
• Intervention / Treatment: Behavioral: Modified Mindfulness Training Program (MMTP)

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Qatar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Receives Modified Mindfulness Training Program (MMTP), adapted to address cultural stressors and reduce antenatal depression.	Behavioral: 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.
No Intervention: Control Group; Receives standard antenatal care without mindfulness intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	One-month follow-up after intervention completion

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar
• Investigators: Principal Investigator: Dr Badil, Institute of Nursing Sciences, Khyber Medical University Peshawar; Principal Investigator: Dr Najma Naz, PhD, Institute of Nursing, Khyber Medical University Peshawar; Principal Investigator: Dr Khalid Rahman, PhD, Institute of Public Health and Social Science, Khyber Medical University Peshawar

Publications and helpful links

General Publications

• Yin 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.
• 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.
• Guo 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.
• Sikander 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.
• Tesfaye 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): April 23, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Perceived Stress; Mindfulness training; Antenatal depression; Male Child preference
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: KMU/DIR/CTU/2024/009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will become available six months after the primary study publication and remain accessible for three years.
• IPD Sharing Access Criteria: Researchers can request access to IPD via a formal application process, which includes justification for use, research objectives, and adherence to data privacy agreements. Access will be granted to qualified researchers following review and approval by the data-sharing committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No