Mental IllnessNCT03966872
Comparative Effectiveness of IIMR Versus CDSMP
A study testing Integrated Illness Management and Recovery and Chronic Disease Self-Management Program in people with Mental Illness and Chronic Disease, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Chronic Disease
- What is being tested?
- Integrated Illness Management and Recovery and Chronic Disease Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2019to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seven Counties Services
Louisville, Kentucky, 40220
Centerstone
Nashville, Tennessee, 37228
About this study
Official title: 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.
Read the 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
- Being tested
- Integrated Illness Management and Recovery, Chronic Disease Self-Management Program
- Keywords
- integrated health, mental health, illness management, cardiovascular disease, physical health
- Medical subject headings
- Mental Disorders, Chronic Disease, Psychological Well-Being, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Illness Management and RecoveryBehavioural
Education and skills training groups on illness management of chronic medical and psychiatric illness.
Chronic Disease Self-Management ProgramBehavioural
Education and skills training groups on illness management of chronic conditions
| Study group | Role | What they receive |
|---|---|---|
| Integrated Illness Management and Recovery (I-IMR): | Experimental | 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) Receives: Behavioral: Integrated Illness Management and Recovery |
| Stanford Chronic Disease Self-Management Program (CDSMP): | Experimental | 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 Receives: Behavioral: Chronic Disease Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 12 months
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.
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start2 Sep 2019
- Primary completion15 Jul 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Sarah Pratt, Dartmouth-Hitchcock Medical Center
- Investigators
- Sarah Pratt, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966872
- Sponsor's protocol ID
- D19103 31245
- Status last verified
- Jul 2026
- First submitted
- 1 May 2019
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program
- ClinicalTrials.gov ID
- NCT03966872
- Acronym / sponsor ID
- D19103 31245
- Conditions
- Mental Illness, Chronic Disease
- Keywords
- integrated health, mental health, illness management, cardiovascular disease, physical health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Illness Management and Recovery (I-IMR): | Experimental | Behavioral: Integrated Illness Management and RecoveryParticipants 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) |
| Stanford Chronic Disease Self-Management Program (CDSMP): | Experimental | Behavioral: Chronic Disease Self-Management ProgramParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Illness Management and RecoveryEducation and skills training groups on illness management of chronic medical and psychiatric illness. | Behavioural | Integrated Illness Management and Recovery (I-IMR): |
| Chronic Disease Self-Management ProgramEducation and skills training groups on illness management of chronic conditions | Behavioural | Stanford Chronic Disease Self-Management Program (CDSMP): |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Pratt principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Illness Management and Recovery and Chronic Disease Self-Management Program in people with Mental Illness and Chronic Disease, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale (time frame: Change from Baseline to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.