Comparative Effectiveness of IIMR Versus CDSMP

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Mental Illness
• Intervention / Treatment: Behavioral: Chronic Disease Self-Management Program; Behavioral: Integrated Illness Management and Recovery

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).

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan Santos, MSW; Phone Number: 603-226-6804; Email: Meghan.M.Santos@Dartmouth.edu
• Study Contact Backup: Name: Gail Williams, MS; Phone Number: 603-226-6803; Email: Gail.E.Williams@Dartmouth.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Recruiting
      • Seven Counties Services
      • Contact: Theresa Watson, RN, MS, CPHQ; Phone Number: 502-436-5696
  • Tennessee
    • Nashville, Tennessee, United States, 37228
      • Recruiting
      • Centerstone
      • Contact: Mandi Ryan; Phone Number: 615-574-1195

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: Integrated Illness Management and Recovery; Education and skills training groups on illness management of chronic medical and psychiatric illness.
Experimental: 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	Behavioral: Chronic Disease Self-Management Program; Education and skills training groups on illness management of chronic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale	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.	Change from Baseline to 12 weeks
Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale	Change in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management.	Change from Baseline to 12 months
Change in Patient Activation on the Patient Activation Measure (PAM)	Change in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation.	Change from Baseline to 12 months
Change in Acute Hospital Events from Electronic Medical Record Review.	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.	Change from Baseline to 12 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Sarah Pratt, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: mental health; cardiovascular disease; physical health; illness management; integrated health
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Mental Disorders; Chronic Disease
• Other Study ID Numbers: D19103 31245

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No