Healthy ReStart Intervention to Improve Health and Functioning

NCT05544344 | Recruiting

• 2 other identifiers: 2021-012590RTHF0004-01-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Outcome Measures

Primary Outcomes (6)

• Change in Perceived Competence

  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.

  Study entry (pre-intervention), 6 months post-study entry

• Change in Depressive Symptoms

  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.

  Study entry (pre-intervention), 6 months post-study entry

• Change in Anxiety Symptoms

  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.

  Study entry (pre-intervention), 6 months post-study entry

• Change in Coping Mastery

  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.

  Study entry (pre-intervention), 6 months post-study entry

• Change in Empowerment

  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.

  Study entry (pre-intervention), 6 months post-study entry

• Change in Recovery

  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.

  Study entry (pre-intervention), 6 months post-study entry

Secondary Outcomes (2)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects receive an intervention with 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.

Behavioral: Healthy ReStart

Services as Usual

ACTIVE COMPARATOR

Subjects receive mental health services as usual.

Other: Services as Usual

Interventions

Healthy ReStart BEHAVIORAL

In addition to receiving mental health services as usual, subjects receive services from health coaches over a four-month period to assist them in creating a Restart plan and attaining related life goals.

Intervention

Services as Usual OTHER

Subjects receive mental health services as usual.

Services as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Trilogy Behavioral Health Care

Chicago, Illinois, 60626, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Judith A Cook, Ph.D.

CONTACT

312-355-3921; jcook@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research interviewers are blinded to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 16, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)