Effectiveness of leisure-based intervention among individuals with schizophrenia on cognitive domains and self-esteem: A mixed-method study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1. Cognitive domains using The Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This study is a mixed method design in which there will be two phases.
Phase 1 will be to develop leisure-based intervention among individuals with schizophrenia.
Phase 2 will be to assess the effectiveness of leisure-based intervention among individuals with schizophrenia in Karnataka, India.
Primary outcome measures will be cognitive domains and self-esteem levels. The Secondary outcomes will be negative symptoms, quality of life, physical activity levels, and social functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with diagnosis of Schizophrenia with score of less than 4 on items of positive symptoms on BPRS scale
- •The participant should be able to give informed consent.
- •The Participant who can speak English or Hindi or Kannada
- •If the participant has a history of longitudinal comorbid psychiatric diagnosis which is currently stable and not on treatment for the same will be included.
排除标准
- •Acute medical co-morbidities such as uncontrolled HTN, Asthma, that affect study participation as well as act as confounding factors
- •Acute Psychiatric co-morbidities affecting participation in the study, 3.Suicidal thoughts
- •Physical disabilities affecting participation in the study,
- •Substance use other than nicotine, 6.In Depression Anxiety Stress Scale (DASS-21) score of more than 4 on depression, more than 3 on anxiety, and more than 7 on stress.
结局指标
主要结局
1. Cognitive domains using The Montreal Cognitive Assessment (MoCA)
时间窗: At baseline, at 4 weeks, at 8 weeks, and at 12 weeks.
2. Self-esteem level using Rosenberg self-esteem scale
时间窗: At baseline, at 4 weeks, at 8 weeks, and at 12 weeks.
次要结局
- 1. social functioning using The Personal and Social Performance (PSP)(2. Physical activity levels using The International Physical Activity Questionnaire (IPAQ-SF))
研究者
Amar Arvind Nishad
Manipal Academy of Higher Education