Comparative Effectiveness of IIMR Versus CDSMP

NCT ID: NCT03966872

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2027-01-31

Brief Summary

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population.

Detailed Description

The proposed study will be the first to compare two commonly used but substantially different, evidence-based self-management interventions. Integrated Illness Management and Recovery (I-IMR), is an individually-tailored, 16-session, integrated program combining both physical and mental health self-management specifically developed for people with SMI. In contrast, the Stanford Chronic Disease Self-Management Program (CDSMP) is a group-based, 6-session, chronic disease self-management program largely focused on physical health self-management alone. I-IMR is delivered by community mental health providers or by community outreach workers, while CDSMP is co-delivered by two peers or by a health professional and a peer. Both programs have been widely recommended, disseminated, and used. The proposed parent study will randomize people with serious mental illness to I-IMR (n=300) and CDSMP (n=300).

Conditions

Mental Illness; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Integrated Illness Management and Recovery (I-IMR):

Participants assigned to I-IMR will receive 2 individual sessions to discuss principles of recovery and set personally meaningful goals, with the remainder of the 14 I-IMR sessions delivered in groups of 8-10 (to enable individual tailoring)

Group Type: EXPERIMENTAL

Integrated Illness Management and Recovery

Intervention Type: BEHAVIORAL

Education and skills training groups on illness management of chronic medical and psychiatric illness.

Stanford Chronic Disease Self-Management Program (CDSMP):

Participants randomly assigned get a 6-session group-based educational program co-delivered by two peers (lay people who have successfully managed a chronic illness) or a peer and a professional

Group Type: EXPERIMENTAL

Chronic Disease Self-Management Program

Intervention Type: BEHAVIORAL

Education and skills training groups on illness management of chronic conditions

Interventions

Integrated Illness Management and Recovery

Education and skills training groups on illness management of chronic medical and psychiatric illness.

Intervention Type: BEHAVIORAL

Chronic Disease Self-Management Program

Education and skills training groups on illness management of chronic conditions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Serious Mental Illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at Centerstone(KY and TN)
• Diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease (e.g., diabetes, hyperlipidemia, hypertension, COPD, heart failure, tobacco dependence, obesity), and at least 1 ER visit or hospitalization within the past year or judgment by the treatment team of substantial need for illness self-management training.

Exclusion Criteria

• Consumers who do not speak English
• Consumers with either no, or a well-controlled medical condition will not be included
• Individuals residing in a nursing home or other institution
• Evidence of significant cognitive impairment as indicated by a Mini Mental Status Examination score <24, will be excluded

Eligibility for the COVID -related substudy is dependent on enrollment and participation in the parent project.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Pratt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Pratt

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Seven Counties Services

Louisville, Kentucky, United States

Site Status: RECRUITING

Centerstone

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meghan Santos, MSW

Role: CONTACT

Meghan.M.Santos@Dartmouth.edu

603-226-6804

Gail Williams, MS

Role: CONTACT

Gail.E.Williams@Dartmouth.edu

603-226-6803

Facility Contacts

Theresa Watson, RN, MS, CPHQ

Role: primary

502-436-5696

Mandi Ryan

Role: primary

615-574-1195

Other Identifiers

D19103 31245

Identifier Type: -

Identifier Source: org_study_id