Individualized Rehabilitation Intervention for Women with Severe mental illness in rural Karnataka- development and feasibility testing
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome: Reduction in disability score
研究概览
简要总结
Women with mental health problems are vulnerable due to gender-specific factors and have limitations in accessing appropriate care. Prior research into rehabilitation need assessment has addressed issues unique to women with mental illness. Available studies were conducted in institutional settings with a cross-sectional design. There is paucity of literature on addressing issues unique to women with severe mental illness in rural communities. Thus, there is a need to study and address rehabilitation needs of women with mental illness in rural community. This will help develop rehabilitation interventions to address unique needs of women with severe mental illness in rural communities. For this researcher would initially develop need assessment interview guide to assess the rehabilitation needs unique to women with severe mental illness in Jagaluru. Need assessment would be followed by development of individualised rehabilitation intervention after in person interview with stakeholders. Individualised intervention would be provided to 30 women recruited through convenience sampling method. Research would be using mixed methodology as research design and would do analysis using thematic analysis (qualitative data) and appropriate statistical tests for quantitative data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Disorders with primary diagnosis meeting the criteria as per International Classification of Diseases (ICD-10) for F.20.0-29; Schizophrenia Schizotypal and delusional disorder, F.31.0-31.9; Bipolar Affective Disorder.
排除标准
- •Individuals who are not amenable to qualitative interviews.
- •Individuals with any neurological disability or life-threatening illness requiring priority medical management.
结局指标
主要结局
The primary outcome: Reduction in disability score
时间窗: T1 baseline before the intervention | T2 six months after the intervention
Indian Disability Evaluation and Assessment Scale (IDEAS) will be used to assess the reduction in the disability score. Scale used are Indian Disability Evaluation and Assessment Scale (IDEAS)Rehabilitation committee of the Indian Psychiatric Society 2002)
时间窗: T1 baseline before the intervention | T2 six months after the intervention
次要结局
- Variables are symptom severity,Level of functioning factors influencing adherence, stigma,Quality of life. Scale used are Clinical impression scale CGI-SCH, CGI- BP(Haro et al., 2003), (Spearing et al., 1997)World Health Organisation Disability Assessment Schedule (WHO-DAS 2.012) item interviewer rating WHO 2010Schedule of Factors Influencing Adherence (SOFIA)Reddy 2013 Internalized stigma of Mental Illness Scale (ISMI)Ritsher, J. B, 2003World Health Organisation-Quality of life -Bref(WHOQOL-bref)WHO 2001(T1 baseline before the intervention)