This trial is active, not recruiting.

Conditions hypertension, arthritis, coronary artery disease, hepatitis, diabetes, asthma, hyperlipidemia, hiv
Treatment harp intervention
Phase phase 3
Sponsor Emory University
Collaborator National Institute of Mental Health (NIMH)
Start date June 2011
End date April 2017
Trial size 400 participants
Trial identifier NCT01725815, 1R01MH090584-01A1, IRB00047631a


Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and also challenges in effectively managing these health problems. There is an urgent need to develop self-management strategies that allow persons with SMI to more effectively manage their chronic medical illnesses.

In general populations, peer-led disease self-management interventions have been demonstrated to be feasible, effective, scalable, and to lead to sustainable improvements in self-management and health outcomes. With funding from an R34 intervention development grant from NIMH, the study team has developed and piloted a modified version of the most widely tested and used peer-led self management program, the Chronic Disease Self-Management Program (CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented with high engagement, retention, and program fidelity, and can result in effect sizes across a range of outcomes comparable to or greater than those seen in general medical populations.

This application proposes to conduct a fully-powered, multisite trial of the HARP program. A total of 400 individuals with serious mental illnesses and one or more chronic medical condition will be recruited from three diverse community mental health clinics in the Atlanta metro region and randomized to the HARP program or usual care. For individuals in the HARP program, two peer educators with SMI and one or more chronic medical condition will lead a six-session, six-week manualized intervention, which helps participants become more effective managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6 months and one year will assess changes in clinical outcomes, improvement in generic and disease-specific measures of illness self-management, and quality of care. During the final phase of the study, a dissemination strategy building on the CDSMP training infrastructure will allow program participants to lead HARP groups.

If successful, this study will establish the first fully peer-led, evidence-based intervention for improving physical self-management in this vulnerable population.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
harp intervention
The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
(No Intervention)

Primary Outcomes

Health related quality of life
time frame: One Year

Secondary Outcomes

Patient Activation
time frame: One Year
Health Behaviors
time frame: One Year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - On CMHC roster of active patients. - Presence of a serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression, obsessive-compulsive disorder, or post-traumatic stress disorder - Chronic Medical Condition as noted in the CMHC chart or via self-report: (hypertension; arthritis; heart disease; diabetes; and asthma/COPD), Exclusion Criteria: - cognitive impairment based on a score of > 3 on a 6-item, validated screener developed for clinical research

Additional Information

Official title A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers
Principal investigator Benjamin Druss, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Emory University.