NCT05467982

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mental Illness
• Chronic Disease

Interventions

Type	Name	Description
BEHAVIORAL	Integrated Illness Management and Recovery	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.
BEHAVIORAL	Chronic Disease Self-Management Program	Education and skills training groups on illness management of chronic conditions

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2022-07-21
• Last updated: 2024-07-12
• Results posted: 2024-07-12

Locations

2 sites across 1 country: United States