Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions
Brief Intervention to Increase COVID-19 Knowledge in People With Serious Mental Illness
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40220
- Seven Counties Services
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Tennessee
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Nashville, Tennessee, United States, 37228
- Centerstone
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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 (NCT03966872).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:
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.
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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.
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Experimental: Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:
No additional COVID-19 intervention was provided to this group.
These participants only received the primary disease management intervention (CDSMP)
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Education and skills training groups on illness management of chronic conditions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Received COVID-19 Vaccine
Time Frame: Baseline to 12 Weeks
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change in status from baseline to follow up, receipt of vaccination or not.
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Baseline to 12 Weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarah Pratt, PhD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00031245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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