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

NCT06685484 | Completed DMC

• 1 other identifier: KMU/DIR/CTU/2024/009
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Antenatal Depression

Keywords

Mindfulness training; Antenatal depression; Male Child preference; Perceived Stress

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Receives Modified Mindfulness Training Program (MMTP), adapted to address cultural stressors and reduce antenatal depression.

Behavioral: Modified Mindfulness Training Program (MMTP)

Control Group

NO INTERVENTION

Receives standard antenatal care without mindfulness intervention.

Interventions

Modified Mindfulness Training Program (MMTP) BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Psychiatric illness history, use of psychiatric medication

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Qatar Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 30779765 BACKGROUND

• 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.

  PMID: 34702205 BACKGROUND

• 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.

  PMID: 33176244 BACKGROUND

• 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.

  PMID: 31061029 BACKGROUND

• 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.

  PMID: 33628509 BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A feasibility trial using the ADAPT-ITT framework will randomly assign participants to two groups.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 23, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available six months after the primary study publication and remain accessible for three years.
• 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.

Locations

PA (1)