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临床试验/NCT06685484
NCT06685484已完成不适用

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

Khyber Medical University Peshawar1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Reduction in Antenatal Depression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Psychiatric illness history, use of psychiatric medication

研究组 & 干预措施

Intervention Group

Experimental

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

干预措施: Modified Mindfulness Training Program (MMTP) (Behavioral)

Control Group

No Intervention

Receives standard antenatal care without mindfulness intervention.

结局指标

主要结局

Reduction in Antenatal Depression

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Khyber Medical University Peshawar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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