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

Chronic Disease Clinical Trial

Official title:

Brief Intervention to Increase COVID-19 Knowledge in People With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05467982
• Other study ID #: STUDY00031245
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2022
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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). Our 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Mental Disorders
• Mental Illness

Intervention

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.
• Chronic Disease Self-Management Program
Education and skills training groups on illness management of chronic conditions

Locations

Country	Name	City	State
United States	Seven Counties Services	Louisville	Kentucky
United States	Centerstone	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale	Change in score on this measure, which was developed as part of the study plan because no suitable scale existed to assess knowledge and safety behaviors for COVID-19. Scores range from 0-100%, with higher scores indicating greater knowledge and enactment of safety behaviors.	Change from Baseline to 12 weeks