Examining the Effect of Combined Mind-body Intervention in Earthquake Survivors: A 6 Months Follow-up Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
研究概览
简要总结
The purpose of this study is to investigate whether a 4-week program called "Combined Mind-Body Intervention" can help survivors of the February 6, 2023, earthquakes manage stress and improve their ability to participate in daily activities. The study specifically aims to answer the following question: Does a program combining guided imagery and progressive muscle relaxation lead to significant, long-term improvements in occupational performance (self-care, work, and leisure), reduced stress levels, and better overall quality of life for earthquake survivors when compared to a control group?
The study will involve:
Target Population: Adults aged 18 to 65 who directly experienced the 2023 earthquakes and currently reside in the affected region .Intervention: Participants in the intervention group will attend eight individual sessions (twice a week) focusing on deep breathing, step-by-step muscle relaxation, and guided visualization of peaceful environments.
Evaluation: Changes in stress, mood, and daily activity performance will be measured at the beginning of the study, at the end of the 4-week program, and during a 6-month follow-up period to determine the lasting effects of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between 18 and 65 years old.
- •Having directly experienced the February 6, 2023 earthquake.
- •Currently residing in the earthquake zone.
- •Possessing sufficient cognitive and language skills to participate in assessments and the intervention.
排除标准
- •Having an additional psychiatric or neurological disease diagnosis.
- •Having received non-pharmacological interventions (such as psychotherapy, CBT, art therapy, or meditation) before or during the study.
- •Currently using psychiatric medications.
- •Having a history of other physical (e.g., violence) or psychological trauma.
- •Being pregnant or currently breastfeeding.
- •Having a current substance addiction.
- •Demonstrating suicidal tendencies.
研究组 & 干预措施
Combined Mind-Body Intervention
his group receives 8 individual sessions, conducted twice weekly for 30 to 40 minutes.Each session consists of Jacobson's progressive muscle relaxation and guided imagery techniques.Participants are also instructed to perform daily home practice
干预措施: combined mind-body intervention (Other)
Control Group (Routine Care & Monitoring)
Participants receive routine care along with supplemental support.They will be contacted by phone twice a week for 4 weeks by the investigator to monitor their general health status.The phone calls are limited to general status inquiries to minimize bias related to investigator attention.
干预措施: Routine Care and Follow-up Phone Calls (Behavioral)
结局指标
主要结局
Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores
时间窗: Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.
The COPM is a semi-structured interview used to identify and prioritize issues in occupational performance. Participants rate their perceived performance and satisfaction for their top five identified problem areas in daily activities (self-care, productivity, and leisure). Both scales use a 10-point Likert scale ranging from 1 ("not able to do it" or "not satisfied") to 10 ("able to do it extremely well" or "extremely satisfied") . Higher scores indicate better occupational performance and higher satisfaction.
次要结局
- Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A)(Baseline, Week 4, and Month 6.)
- Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D)(Baseline, Week 4, and Month 6.)
- Nottingham Health Profile (NHP) Domain Scores(Baseline, Week 4, and Month 6.)
研究者
Emine Sağlamoğlu
research assistant/ MSc OT
Hacettepe University