Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Medical illness self-management skills
研究概览
简要总结
This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.
详细描述
Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.
Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- •Current documented chart diagnosis of at least one chronic medical condition
- •Received clinic services for a minimum of 3 months prior to study entry
- •English-speaking
- •Willing to use an effective form of birth control throughout the study if sexually active
排除标准
- •History of a serious neurological disorder or head trauma with loss of consciousness
- •Diagnosed with mental retardation or dementia
- •Diagnosed with end stage organ disease
- •Currently receiving chemotherapy and/or radiation treatment for cancer
- •Received psychiatric hospitalization less than 3 months prior to study entry date
- •Blind and/or deaf
- •Infected with HIV with a CD4 count under 350
- •Diagnosis of AIDS
- •Diagnosis of anorexia
- •Problematic substance use, as defined by a mental health provider
- •Psychiatric instability, as defined by a mental health provider
研究组 & 干预措施
1
Participants will receive a self-management program for chronic illness
干预措施: Self-management program for chronic illness (Behavioral)
Usaual Care
Usual Care; no additional intervention
结局指标
主要结局
Medical illness self-management skills
时间窗: Measured at pre- and post-intervention
Physical and mental health status
时间窗: Measured at pre- and post-intervention
Medical service use patterns
时间窗: Measured at pre- and post-intervention
Social and communication skills during interactions with health care providers
时间窗: Measured at pre- and post-intervention
Health-related self-efficacy and recovery orientation
时间窗: Measured at pre- and post-intervention
次要结局
- Psychiatric symptoms(Measured at pre- and post-intervention)
- Amount and seriousness of related comorbidities(Measured at pre- and post-intervention)
- Medication use(Measured throughout the study)
- Neurocognition(Measured at baseline)
- Substance abuse(Measured at pre- and post-intervention)
- Quantitative and qualitative survey ratings(Measured throughout the study)
研究者
Richard Goldberg
PI
University of Maryland, Baltimore