Targeted Self-Management for Epilepsy and Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Change in Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
For this project we propose to refine the psychosocial intervention developed in phase one, based on input from key stakeholders, and to test the feasibility, acceptability and preliminary efficacy of the intervention. The proposed project addresses unmet public health needs for a historically hard-to-reach group of individuals with epilepsy and comorbid serious mental illnesses, and as the intervention is an adjunct to care that individuals with serious mental illness are already receiving, and uses staff already likely to be present in a care system, it is ideally suited for "real-world" implementation in people with epilepsy and serious mental illness (E-SMI).
The purpose of this study is to try and engage individuals with E-SMI to actively participate in illness self-management and treatment adherence that are crucial in minimizing the morbidity and mortality associated with both chronic mental disorders and chronic neurological conditions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written consent
- •Able to speak and understand English
- •Age 18 and older
- •Diagnosed with epilepsy
- •Diagnosed with serious mental illness (DSM IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or chronic/recurrent depression confirmed with the Mini-International Neuropsychiatric Interview (MINI))
- •Receive care at a community mental health center or other publicly funded community healthcare entity
排除标准
- •Actively suicidal/homicidal individuals
- •Individuals with dementia
- •Unable to be rated on study rating scales
- •Pregnant women
结局指标
主要结局
Change in Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Baseline to Week 16
The MADRS measures symptoms of depression. Total scores on MADRS range from 0-60, with higher scores indicating more severe depression.
次要结局
- World Health Organization Disability Assessment (WHODAS II)(Baseline, 12 Week, 16 Week)
- Quality of Life Questionnaire (QOLIE-10)(Baseline, 12 Week, 16 Week)
- Patient Health Questionnaire (PHQ-9)(Baseline, 12 Week, 16 Week)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 12 Week, 16 Week)
- Brief Psychiatric Rating Scale (BPRS)(Baseline, 12 Week, 16 Week)
- Global Assessment of Functioning (GAF)(Baseline, 12 Week, 16 Week)
- Seizure Frequency - Past 30 Days(Baseline, 12 Week, 16 Week)
研究者
Martha Sajatovic, MD
Professor of Psychiatry
Case Western Reserve University