Feasibility, Acceptability, and Preliminary Effectiveness of a Hatha Yoga-on Reminiscence Functions and Mindfulness in Patients Hospitalized for Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- The Five-Facet Mindfulness Questionnaire-15 (FFMQ-15)
研究概览
简要总结
The current study aims to examine the feasibility, acceptability, and preliminary effectiveness of a Hatha yoga-based group intervention on reminiscence functions and mindfulness in a sample of patients hospitalized for schizophrenia.
详细描述
This study employs a mixed-methods sequential explanatory design. Convenience sampling will be used to recruit 36 participants for a cross-culturally adapted Hatha yoga-based group intervention (16 one hour-long sessions over 8 weeks). Feasibility indicators will be monitored systematically. Acceptability will be assessed using semi-structured interviews. Preliminary effectiveness will be evaluated using a quasi-experimental one-group pre-post test design to test group-level (paired t-test) and individual-level (reliability change index) changes in mindfulness and reminiscence functions. Thematic analysis will be conducted to analyze qualitative data, with meta-inference used to integrate the qualitative and quantitative findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are diagnosed with schizophrenia according to the DSM-5-TR or ICD-10 criteria
- •Patients are aged between 18 and 65 years old
- •Patients are clinically stabile, defined as being in the post-acute phase of care with no acute psychotic episode or psychiatric hospitalization within the 30 days preceding enrollment
- •Patients have adequate cognitive functioning, as evidenced by passing the Mini-Mental State Examination (MMSE), with sufficient insight and capacity to respond meaningfully to study procedures
- •Patients have the ability to attend group-based sessions and provide informed consent
- •Patients have the willingness and physical ability to engage safely in light-to-moderate yoga practice.
排除标准
- •Patients with severe cognitive impairment or intellectual disability that would disqualify meaningful participation
- •Patients with acute psychiatric symptoms or active suicidal ideation
- •Patients with physical limitations, such as a severe musculoskeletal condition, that would contraindicate safe participation in yoga practice.
研究组 & 干预措施
Experimental
Hatha Yoga-Based Group Intervention
干预措施: Intervention Arm: Hatha Yoga (Behavioral)
结局指标
主要结局
The Five-Facet Mindfulness Questionnaire-15 (FFMQ-15)
时间窗: 12 weeks
The Five-Facet Mindfulness Questionnaire-15 is a 15-item self-report measure assessing five domains: observing, describing, acting with awareness, nonjudging, and nonreactivity. Each item is rated on a 5-point Likert scale from 1 to 5. Total scores range from 15 to 75. Higher scores indicate higher levels of dispositional mindfulness, reflecting a better outcome.
Feasibility Indicators: Recruitment Retention Attrition Adherence Data completeness Adverse events.
时间窗: 10 weeks
1. Recruitment rate: Percentage of eligible participants enrolled during the 10-week recruitment period, calculated as the number who provide written consent divided by the total eligible participants approached, multiplied by 100. 2. Retention rate: Percentage of enrolled participants who complete the week 10 assessment, calculated as completers divided by total enrolled at baseline, multiplied by 100. 3. Attrition rate: Percentage of participants who withdraw before week 10, calculated as discontinuations divided by total enrolled, multiplied by 100. 4. Adherence: Attendance rate across scheduled sessions, calculated as sessions attended divided by total sessions, multiplied by 100. 5. Data completeness: Percentage of completed outcome assessment items at baseline and week 10, calculated as completed items divided by total expected items, multiplied by 100. 6. Adverse events: Number and proportion of participants experiencing adverse events during the intervention period.
次要结局
- The 18-item Tripartite Adjusted Arabic Reminiscence Functions Scale (AARFS-tri)(12 weeks)
研究者
Abdallah Abu Khait
Dr.
The Hashemite University