Healthy ReStart Intervention to Improve Health and Functioning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Perceived Competence
研究概览
简要总结
This study tests an intervention that uses health coaching, motivational interviewing, positive psychology, and online wellness tools to help adults with mental illness return to active lives after major disruptions such as the COVID-19 pandemic.
详细描述
This study is testing the efficacy of a brief intervention delivered to adults with mental illness by trained health coaches, designed to help recipients engage in health and mental health self-management, while setting goals to return to an active life after major disruptions such as a pandemic. Adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. They are assessed at baseline and 6 months later. Analysis of covariance (ANCOVA) models are used to assess the primary outcome of changes in mental and physical health, functioning, perceived competence for life self-management, and mental health recovery. Also examined are study condition differences in self-advocacy skills, access to services, and disruptions from COVID-19.
Hypothesis 1: Compared to services as usual (SAU), intervention recipients will report better health, well-being, and service use.
Hypothesis 2: Compared to SAU, intervention recipients will have more perceived competence and self-advocacy.
Hypothesis 3: Healthy ReStart recipients will report high levels of satisfaction with the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research interviewers are blinded to study condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and older
- •Diagnosis of serious mental illness defined as a DSM 5 psychiatric disorder and moderate to severe functional impairment
- •Membership in a collaborating community mental health agency
- •Access to the Internet for online meetings
- •Able to provide informed consent
排除标准
- •A cognitive impairment preventing informed consent
- •Unable to communicate in English
结局指标
主要结局
Change in Perceived Competence
时间窗: Study entry (pre-intervention), 6 months post-study entry
Change in participants' feelings of competence about their ability to improve their lives and follow through on their life goals as measured by the Perceived Competence scale. This 4-item scale using a 7-point Likert response format ranging from "not at all true" to "very true." The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Change in Coping Mastery
时间窗: Study entry (pre-intervention), 6 months post-study entry
Change in subjects' sense of personal control over important life outcomes is measured by the Coping Mastery Scale. Higher values equal better coping mastery. Minimum=2 and maximum=49.
Change in Depressive Symptoms
时间窗: Study entry (pre-intervention), 6 months post-study entry
Change in symptoms of depression and anhedonia is measured by the Patient Health Questionniare-9. Total score ranges from 0 to 27 with higher values indicating greater likelihood of depressive disorder. Total score is calculated by adding the 9 item scores.
Change in Anxiety Symptoms
时间窗: Study entry (pre-intervention), 6 months post-study entry
Change in anxiety symptoms is measured by The Generalized Anxiety Disorder 7-item Questionnaire. Total score ranges from 0 to 21 with higher values indicating greater likelihood of generalized anxiety disorder. Total score is calculated by adding the 7 item scores.
Change in Empowerment
时间窗: Study entry (pre-intervention), 6 months post-study entry
Change in empowerment is measure by the Empowerment Scale. This 28-item instrument designed to measure subjective feelings of empowerment via self-report in which respondents answer questions on a four-point scale ranging from Strongly Agree to Strongly Disagree. The minimum score is 28 and the maximum is 112, with higher scores indicating a better outcome.
Change in Recovery
时间窗: Study entry (pre-intervention), 6 months post-study entry
Change in recovery is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree." The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms.
次要结局
- Change in Physical and Mental Functioning(Study entry (pre-intervention), 6 months post-study entry)
- Change in Ability to Self-Advocate(Study entry (pre-intervention), 6 months post-study entry)
研究者
Judith A. Cook
Professor
University of Illinois at Chicago