N/A
N=162
Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions
Mental Illness · Chronic Disease
Bottom Line
View on ClinicalTrials.gov: NCT05467982 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants Who Received COVID-19 Vaccine — 56; 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrated Illness Management and Recovery (Behavioral); Chronic Disease Self-Management Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received COVID-19 Vaccine |
56; 50 | — |
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 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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT05467982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.