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

NCT ID: NCT06685484

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-04-23

Brief Summary

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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

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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

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Antenatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A feasibility trial using the ADAPT-ITT framework will randomly assign participants to two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Modified Mindfulness Training Program (MMTP)

Intervention Type 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.

Control Group

Receives standard antenatal care without mindfulness intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khyber Medical University Peshawar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Badil

Role: PRINCIPAL_INVESTIGATOR

Institute of Nursing Sciences, Khyber Medical University Peshawar

Dr Najma Naz, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nursing, Khyber Medical University Peshawar

Dr Khalid Rahman, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Public Health and Social Science, Khyber Medical University Peshawar

Locations

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Qatar Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30779765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34702205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33176244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31061029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33628509 (View on PubMed)

Other Identifiers

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KMU/DIR/CTU/2024/009

Identifier Type: -

Identifier Source: org_study_id

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