Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions

NCT ID: NCT05467982

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-04-30

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.

Conditions

Mental Illness; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Integrated Illness Management and Recovery

Intervention Type: BEHAVIORAL

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.

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)

Group Type: EXPERIMENTAL

Chronic Disease Self-Management Program

Intervention Type: BEHAVIORAL

Education and skills training groups on illness management of chronic conditions

Interventions

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.

Intervention Type: BEHAVIORAL

Chronic Disease Self-Management Program

Education and skills training groups on illness management of chronic conditions

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Pratt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Pratt, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Seven Counties Services

Louisville, Kentucky, United States

Centerstone

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00031245

Identifier Type: -

Identifier Source: org_study_id