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Active, Not Recruiting

NCT Number: NCT03966872

Comparative Effectiveness of IIMR Versus CDSMP

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mental Illness Behavior Cardiovascular Diseases Chronic Disease Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seven Counties Services, Louisville, Kentucky, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated Illness Management and Recovery

Behavioral

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

Chronic Disease Self-Management Program

Behavioral

Education and skills training groups on illness management of chronic conditions

Primary outcomes

  1. Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale

    Time frame: Change from Baseline to 12 months

    Change in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management.

  2. Change in Patient Activation on the Patient Activation Measure (PAM)

    Time frame: Change from Baseline to 12 months

    Change in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation.

  3. Change in Acute Hospital Events from Electronic Medical Record Review.

    Time frame: Change from Baseline to 12 months

    Change in the number of acute hospital events. At each assessment a combination of participant report and verified information from mental health clinics will be used to validate the number acute hospital events.

  4. Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale

    Time frame: Change from Baseline to 12 weeks

    Change in score on this measure, which was developed as part of the study plan because no suitable scale existed to assess knowledge and safety behaviors for COVID-19. Scores range from 0-100%, with higher scores indicating greater knowledge and enactment of safety behaviors.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
May 29, 2019
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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