Clinical trial NCT05467982: Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions
Official title: Brief Intervention to Increase COVID-19 Knowledge in People With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Chronic Disease
Keywords: integrated health
mental health
illness management
cardiovascular disease
physical health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-07-21
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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).

Primary outcomes:
measure: Number of Participants Who Received COVID-19 Vaccine
timeFrame: Baseline to 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Seven Counties Services
state: Kentucky
city: Nashville
country: United States
facility: Centerstone
state: Tennessee
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Sarah Pratt, PhD
role: PRINCIPAL_INVESTIGATOR
References: