Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Receives Modified Mindfulness Training Program (MMTP), adapted to address cultural stressors and reduce antenatal depression. |
|
| Control Group | No Intervention | Receives standard antenatal care without mindfulness intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qatar Hospital | Karachi | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30779765 | Background | 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. | |
| 34702205 | 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. |
Not provided
Not provided
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.
The data will become available six months after the primary study publication and remain accessible for three years.
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.
Not provided
Not provided
A feasibility trial using the ADAPT-ITT framework will randomly assign participants to two groups.
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 33176244 | 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. |
| 31061029 | 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. |
| 33628509 | 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. |