Clinical trial NCT05544344: Healthy ReStart Intervention to Improve Health and Functioning
Official title: Healthy ReStart Intervention to Improve Health and Functioning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2022-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention includes 4 components: establishing a working alliance with a health coach, completing an online inventory to assess personal wellness in eight life areas, developing a Restart plan that includes personalized life goals, and follow-along with a health coach to address barriers to goal attainment and to reinforce achievement.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* A cognitive impairment preventing informed consent
* Unable to communicate in English

Primary outcomes:
measure: Change in Perceived Competence
timeFrame: Study entry (pre-intervention), 6 months post-study entry
measure: Change in Depressive Symptoms
timeFrame: Study entry (pre-intervention), 6 months post-study entry
measure: Change in Anxiety Symptoms
timeFrame: Study entry (pre-intervention), 6 months post-study entry
measure: Change in Coping Mastery
timeFrame: Study entry (pre-intervention), 6 months post-study entry
measure: Change in Empowerment
timeFrame: Study entry (pre-intervention), 6 months post-study entry
measure: Change in Recovery
timeFrame: Study entry (pre-intervention), 6 months post-study entry
Secondary outcomes:
measure: Change in Physical and Mental Functioning
timeFrame: Study entry (pre-intervention), 6 months post-study entry
measure: Change in Ability to Self-Advocate
timeFrame: Study entry (pre-intervention), 6 months post-study entry
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Trilogy Behavioral Health Care
state: Illinois
Study officials:
References: