Healthy ReStart Intervention to Improve Health and Functioning

NCT ID: NCT05544344

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Research interviewers are blinded to study condition.

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Healthy ReStart

Intervention Type 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.

Services as Usual

Subjects receive mental health services as usual.

Group Type ACTIVE_COMPARATOR

Services as Usual

Intervention Type OTHER

Subjects receive mental health services as usual.

Interventions

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Healthy ReStart

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 Type BEHAVIORAL

Services as Usual

Subjects receive mental health services as usual.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Judith A. Cook

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Trilogy Behavioral Health Care

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Judith A Cook, Ph.D.

Role: CONTACT

312-355-3921

Facility Contacts

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Samantha Hadley

Role: primary

Other Identifiers

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90RTHF0004-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-0125

Identifier Type: -

Identifier Source: org_study_id

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