Mental IllnessNCT05467982
Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions
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
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (NCT03966872).
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: Brief Intervention to Increase COVID-19 Knowledge in People With Serious Mental Illness
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. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 2020.
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).
The COVID-related Enhancement will involve enrolling 150 participants from the parent project to an evaluation of an additional I-IMR module compared to usual care during the pandemic. The I-IMR module will be delivered by trained interventionists in 3 calls over 3 weeks to n=75 I-IMR participants. The I-IMR participants and CDSMP participants will continue to receive Usual Care, consisting of generic support calls from clinicians at the study sites. Baseline, and 6, 9, and 12 week assessments will evaluate the effectiveness of the COVID-19 module that will be added to I-IMR.
- 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. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
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) PLUS COVID-19 ENHANCEMENT: | Experimental | In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists. Receives: Behavioral: Integrated Illness Management and Recovery |
| Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: | Experimental | No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP) Receives: Behavioral: Chronic Disease Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received COVID-19 Vaccine
change in status from baseline to follow up, receipt of vaccination or not.
Measured: 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 posted21 Jul 2022
- Study start1 Oct 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- 164 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, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467982
- Sponsor's protocol ID
- STUDY00031245
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2022
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Increase COVID-19 Knowledge in People With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05467982
- Acronym / sponsor ID
- STUDY00031245
- Conditions
- Mental Illness, Chronic Disease
- Keywords
- integrated health, mental health, illness management, cardiovascular disease, physical health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Posted 12 Jul 2024
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. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 2020.
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).
The COVID-related Enhancement will involve enrolling 150 participants from the parent project to an evaluation of an additional I-IMR module compared to usual care during the pandemic. The I-IMR module will be delivered by trained interventionists in 3 calls over 3 weeks to n=75 I-IMR participants. The I-IMR participants and CDSMP participants will continue to receive Usual Care, consisting of generic support calls from clinicians at the study sites. Baseline, and 6, 9, and 12 week assessments will evaluate the effectiveness of the COVID-19 module that will be added to I-IMR.
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) PLUS COVID-19 ENHANCEMENT: | Experimental | Behavioral: Integrated Illness Management and RecoveryIn addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists. |
| Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: | Experimental | Behavioral: Chronic Disease Self-Management ProgramNo additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP) |
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 (NCT03966872).
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. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module. | Behavioural | Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT: |
| Chronic Disease Self-Management ProgramEducation and skills training groups on illness management of chronic conditions | Behavioural | Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: |
Primary outcome
Number of Participants Who Received COVID-19 Vaccine
Time frame: Baseline to 12 Weeks
change in status from baseline to follow up, receipt of vaccination or not.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to share IPD at this time.
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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, PhD 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: finished, as of the sponsor's last update on 12 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received COVID-19 Vaccine (time frame: Baseline to 12 Weeks). 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 12 Jul 2024.