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临床试验/NCT07283601
NCT07283601已完成不适用

Mindfulness-Based Stress Reduction for Disaster-Affected Women: A Randomized Controlled Trial

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Primary Outcome Measure: Change in perceived stress level measured by the Perceived Stress Scale (PSS-10) from baseline to week 8

研究概览

简要总结

Hypothesis:

Women affected by large-scale disasters who participate in an eight-week Mindfulness-Based Stress Reduction (MBSR) program will experience significantly lower perceived stress levels compared to those in the control group without intervention.

详细描述

Objective

This study aims to describe the effect of the Mindfulness-Based Stress Reduction Program (MBSRP) administered in relation to post-disaster stress.

Material and Method: The present study was carried out by using a quasi-experimental design with 35 participants in the intervention group and 33 in the control group. Personal Information Form, Mindful Attention Awareness Scale (MAAS), and Perceived Stress Scale (PSS) were employed in the data collection process. The women in the intervention group underwent an 8-week Mindfulness Stress Reduction Program. Data were collected through pretests and posttests.

Descriptive statistics were used for data analysis. Independent samples t-test and dependent samples t-test were utilized for the control and intervention groups. The relationship between continuous variables was analyzed by using Pearson Correlation analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female participants aged 18-65 years. Have been directly affected by a large-scale disaster (e.g., earthquake, flood, fire, or similar event) within the past 12-24 months.
  • Report moderate or high perceived stress levels (Perceived Stress Scale [PSS-10] score ≥ 14).
  • Able to attend weekly MBSR sessions for 8 consecutive weeks. Willing to provide written informed consent to participate in the study.

排除标准

  • Current diagnosis of severe psychiatric disorder (e.g., psychosis, bipolar disorder, severe major depression).
  • Ongoing psychotherapy or psychopharmacological treatment for stress, anxiety, or depression at the time of enrollment.
  • Prior participation in any mindfulness or meditation-based program within the last 6 months.
  • Presence of a serious medical condition (e.g., uncontrolled hypertension, cardiovascular disease) that could interfere with participation.
  • Pregnancy or postpartum period (<6 months), if it affects stress levels or participation.
  • Inability to understand study instructions or complete questionnaires in Turkish.

结局指标

主要结局

Primary Outcome Measure: Change in perceived stress level measured by the Perceived Stress Scale (PSS-10) from baseline to week 8

时间窗: Baseline (Week 0) - before the start of the intervention Post-intervention (Week 8) - immediately after completion of the 8-week MBSR program Follow-up (Week 12 or Week 16) - four to eight weeks after the intervention to assess maintenance of effects

Primary Outcome Title: Perceived Stress Level Description: The primary outcome will be the change in perceived stress levels from baseline to 8 weeks after the intervention. Measurement Tool: Perceived Stress Scale (PSS-10), a validated 10-item self-report questionnaire that measures the degree to which situations in one's life are appraised as stressful. Time Frame: Baseline (Week 0) and Post-intervention (Week 8) Scoring and Interpretation: Total scores range from 0 to 40, with higher scores indicating greater perceived stress. A decrease in the mean PSS-10 score from baseline to week 8 in the intervention group compared to the control group will indicate a positive treatment effect. Type of Outcome: Continuous variable (mean score difference between groups)

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leyla SEZGİN

Lecturer

Muş Alparslan University

研究点 (1)

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