Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03966872

Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program

Led by Dartmouth-Hitchcock Medical Center · Updated on 2025-04-10

600

Participants Needed

2

Research Sites

35 weeks

Total Duration

On this page

Sponsors

D

Dartmouth-Hitchcock Medical Center

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two different evidence-based self-management programs for people with serious mental illness who also have chronic medical conditions. The study compares Integrated Illness Management and Recovery (I-IMR), a program developed to train individuals on both physical and mental health self-management, with the Stanford Chronic Disease Self-Management Program (CDSMP), which focuses mainly on physical health self-management. This study aims to understand which program better supports people with serious mental illness in managing their health and preventing hospital events. The study randomly assigns 600 participants to one of two groups: 300 will receive I-IMR, which consists of 16 sessions including 2 individual sessions for recovery principles and goal setting followed by 14 group sessions tailored to individual needs; the other 300 will participate in the CDSMP, a group-based 6-session educational program co-delivered by trained peers or a peer and a health professional. Both interventions are delivered through community mental health providers or outreach workers. Participants will be involved in assessments over 12 months, including measuring their knowledge and skills in illness management, patient activation, acute hospital events through medical record review, and behaviors related to preventing COVID-19 spread over 12 weeks. Researchers will track progress from baseline through these follow-up periods to evaluate changes in self-management abilities and health outcomes. The total study duration extends to early 2027, with safety and outcome monitoring throughout.

CONDITIONS

Brief Title

Comparative Effectiveness of IIMR Versus CDSMP

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of serious mental illness such as schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment
  • Receiving services at Centerstone in Kentucky or Tennessee
  • Diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease
  • At least one emergency room visit or hospitalization in the past year or judged by treatment team to need illness self-management training
Not Eligible

You will not qualify if you...

  • Non-English speakers
  • Individuals with no or well-controlled medical conditions
  • Residents of nursing homes or other institutions
  • Significant cognitive impairment indicated by a Mini Mental Status Examination score less than 24
  • Eligibility for the COVID-related substudy depends on participation in the parent study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 16 weeks depending on assigned program

Participants receive either the Integrated Illness Management and Recovery (I-IMR) program or the Chronic Disease Self-Management Program (CDSMP) involving group-based education and skills training on illness management.

16 group sessions for I-IMR or 6 group sessions for CDSMP

Follow-up

Duration - Up to 12 months

Participants are monitored for changes in knowledge, skills, patient activation, and health events up to 12 months after baseline.

Periodic visits for assessments

Trial Site Locations

Total: 2 locations

1

Seven Counties Services

Louisville, Kentucky, United States, 40220

Actively Recruiting

2

Centerstone

Nashville, Tennessee, United States, 37228

Actively Recruiting

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Research Team

M

Meghan Santos, MSW

G

Gail Williams, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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