IIMR vs CDSMP for Mental Health Disorders

Recruiting at 1 trial location

Overseen By Gail Williams, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Non-English speakers, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is the Illness Management and Recovery (IMR) program safe for people with mental health disorders?

The available research on the Illness Management and Recovery (IMR) program does not specifically mention any safety concerns, suggesting it is generally safe for people with mental health disorders. ^{1 2 3 4 5}

How is the IIMR vs CDSMP treatment different from other treatments for mental health disorders?

The IIMR (Integrated Illness Management and Recovery) and CDSMP (Chronic Disease Self-Management Program) are unique because they focus on teaching people with serious mental illnesses skills to manage their conditions and achieve personal recovery goals. Unlike traditional treatments that may focus solely on medication, these programs emphasize self-management, goal-setting, and social skills training to improve overall recovery. ^{2 5 6 7 8}

What data supports the effectiveness of the treatment IIMR vs CDSMP for Mental Health Disorders?

Research shows that chronic disease self-management programs can improve quality of life and reduce hospital visits for people with chronic conditions, and these strategies are starting to be used in mental health care. Additionally, Illness Management and Recovery programs have shown promising results in helping people with serious mental illnesses manage their conditions and achieve personal recovery goals. ^{2 4 6 9 10}

Who Is on the Research Team?

Sarah Pratt

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for people with serious mental illnesses like schizophrenia or bipolar disorder, who also have a chronic physical condition such as diabetes or heart disease. They should have had an ER visit or hospitalization in the past year and need help managing their health. It's only for those receiving services at Centerstone in KY or TN and who speak English.

Inclusion Criteria

I have a chronic condition like diabetes or heart disease and was hospitalized or visited the ER last year.

I have a serious mental illness and am getting help from Centerstone in KY or TN.

Exclusion Criteria

Individuals residing in a nursing home or other institution

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

You have a test that measures how well your brain is working, called the Mini Mental Status Examination. If your score is less than 24, it means you have significant problems with your thinking and memory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the I-IMR or CDSMP program. I-IMR consists of 16 sessions, while CDSMP consists of 6 sessions.

16 weeks

16 sessions for I-IMR, 6 sessions for CDSMP

Follow-up

Participants are monitored for changes in patient activation, knowledge, and hospital events.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Chronic Disease Self-Management Program
• Integrated Illness Management and Recovery

Trial Overview The study compares two programs: I-IMR, which helps people with serious mental illness manage both physical and mental health, and CDSMP, focused on managing physical health conditions. The goal is to see which program better supports individuals' self-management of their chronic diseases.

How Is the Trial Designed?

Group I: Stanford Chronic Disease Self-Management Program (CDSMP): Experimental Treatment 1 Intervention

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 II: Integrated Illness Management and Recovery (I-IMR): Experimental Treatment 1 Intervention

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)

Chronic Disease Self-Management Program is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CDSMP for:

• Chronic diseases management
• Self-management of physical health conditions

Approved in European Union as CDSMP for:

• Chronic diseases management
• Self-management of physical health conditions

Approved in Canada as CDSMP for:

• Chronic diseases management
• Self-management of physical health conditions

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A systematic review identified 10 studies on chronic disease self-management (CDSM) programs specifically for U.S. adults with serious mental illness (SMI), showing favorable treatment effects across various clinical settings.

The methodological quality of these CDSM studies varied widely, highlighting the need for improved research quality in this emerging field to better support individuals with SMI who face significant chronic disease burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic disease self-management interventions for adults with serious mental illness: a systematic review of the literature. Siantz, E., Aranda, MP.[2022]

Chronic disease self-management (CDSM) is an effective approach in healthcare that empowers patients with chronic conditions to actively manage their health, leading to reduced hospital admissions and improved quality of life.

In psychiatry, CDSM emphasizes collaboration between patients and healthcare professionals through mechanisms like shared decision-making and wellness planning, marking a shift from traditional treatment models where patients were more passive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 'chronic disease self-management strategies' in mental healthcare. Kemp, V.[2011]

Consumers with severe mental illness who participated in illness management and recovery programs had significantly fewer hospitalization days compared to those who only received assertive community treatment (ACT).

Graduates of the illness management and recovery program experienced fewer emergency room visits than those receiving only ACT, indicating that this structured program may enhance overall health service utilization outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of illness management and recovery programs on hospital and emergency room use by Medicaid enrollees. Salyers, MP., Rollins, AL., Clendenning, D., et al.[2021]

Consumers with serious mental illnesses are increasingly being involved as active partners in their treatment, which is essential for recovery-oriented services.

Self-management strategies are crucial for empowering consumers to take control of their lives and collaborate effectively with healthcare professionals in managing their conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the special issue on illness self-management. Mueser, KT., Cook, JA.[2013]

Participants with serious mental illnesses reported high levels of perceived helpfulness from the Illness Management and Recovery (IMR) program one year after completion, indicating its lasting positive impact.

The IMR program was found to improve cognition, coping, and social support, and was perceived as unique compared to other rehabilitation interventions due to its focus on learning, structured support, and a message of hope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A one year follow-up of illness management and recovery: participants' accounts of its impact and uniqueness. Roe, D., Hasson-Ohayon, I., Salyers, MP., et al.[2019]

In a randomized trial involving 198 Danish patients with schizophrenia or bipolar disorder, the Illness Management and Recovery (IMR) program showed no significant effects on functioning, symptoms, or service utilization compared to usual treatment.

The study highlights the need for further research to better understand the effectiveness of the IMR program, as current evidence remains insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illness management and recovery: Clinical outcomes of a randomized clinical trial in community mental health centers. Dalum, HS., Waldemar, AK., Korsbek, L., et al.[2018]

Integrating the Illness Management and Recovery (IMR) program into Assertive Community Treatment (ACT) showed promising results, with participants demonstrating significantly better self-management of their illness after one year compared to those receiving standard ACT services.

The study, involving 101 individuals with serious mental illnesses, suggests that the effectiveness of IMR may depend on the level of participation, as higher session attendance and module completion were linked to better outcomes, indicating a potential dose-response relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Illness Management and Recovery Within Assertive Community Treatment: A Pilot Trial of Feasibility and Effectiveness. Monroe-DeVita, M., Morse, G., Mueser, KT., et al.[2022]

In a study involving 198 participants with schizophrenia or bipolar disorders, the Illness Management and Recovery (IMR) program did not show significant improvements in clinical recovery outcomes, such as symptoms and global functioning, one year after the intervention.

The IMR program also failed to demonstrate any impact on personal recovery measures, like hope and personal agency, suggesting that alternative interventions may be necessary to support individuals with severe mental illness in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illness management and recovery: one-year follow-up of a randomized controlled trial in Danish community mental health centers: long-term effects on clinical and personal recovery. Jensen, SB., Dalum, HS., Korsbek, L., et al.[2020]

A pilot study involving 26 Taiwanese patients with schizophrenia showed that a culturally adapted version of the Illness Management and Recovery (IMR) program significantly improved participants' treatment-related illness knowledge, insight, and psychopathology after just 3 weeks of intervention.

The program was well-attended, with participants averaging 5.45 out of 6 sessions, indicating a positive reception and engagement, which suggests that this tailored approach could be effective for managing schizophrenia during hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of an illness management and recovery program in discharged patients with schizophrenia. Lin, EC., Shao, WC., Chan, CH., et al.[2013]

This study will evaluate the effectiveness of the Illness Management and Recovery (IMR) program compared to standard treatment in 200 outpatient clients with severe mental illnesses, aiming to improve illness management, reduce symptoms, and enhance recovery over 18 months.

The research will utilize a randomized controlled trial design, which is a strength as it allows for robust comparisons and aims to explore the mechanisms of IMR, potentially leading to better outcomes for individuals with various types of severe mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of illness management and recovery (IMR) in the Netherlands: a randomised clinical trial. Roosenschoon, BJ., Mulder, CL., Deen, ML., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Chronic disease self-management interventions for adults with serious mental illness: a systematic review of the literature. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Use of 'chronic disease self-management strategies' in mental healthcare. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of illness management and recovery programs on hospital and emergency room use by Medicaid enrollees. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Introduction to the special issue on illness self-management. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

A one year follow-up of illness management and recovery: participants' accounts of its impact and uniqueness. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Illness management and recovery: Clinical outcomes of a randomized clinical trial in community mental health centers. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Implementing Illness Management and Recovery Within Assertive Community Treatment: A Pilot Trial of Feasibility and Effectiveness. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Illness management and recovery: one-year follow-up of a randomized controlled trial in Danish community mental health centers: long-term effects on clinical and personal recovery. [2020]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

A pilot study of an illness management and recovery program in discharged patients with schizophrenia. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of illness management and recovery (IMR) in the Netherlands: a randomised clinical trial. [2019]