Life Goals Behavioral Change to Improve Outcomes for Veterans With Serious Mental Illness
|ClinicalTrials.gov Identifier: NCT01244854|
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : June 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Schizophrenia Major Depressive Disorder Chronic Affective Disorders Cardiovascular Disease Risk||Behavioral: Life Goals Collaborative Care||Not Applicable|
Background: Persons with serious mental illness (SMI, including schizophrenia, bipolar disorder, or chronic affective disorders) experience a disproportionate burden of medical comorbidity, notably cardiovascular disease (CVD), leading to poor functioning and premature mortality. CVD risk factors in persons with SMI are attributable to unhealthy lifestyles exacerbated by mental health-related symptoms, medication side effects (e.g., weight gain), and the fragmentation of physical and mental health services.
Objectives: The specific aims of this rapid response proposal pilot study are 1) to adopt and test the feasibility of an evidence-based psychosocial intervention (Life Goals Collaborative Care- or LGCC) designed to promote health behavioral change that was developed for bipolar disorder to a broader SMI patient population, and 2) to describe the implementation of LGCC and the barriers and facilitators of adoption to a more generalizable SMI patient population, and to vet the program to key VA stakeholders in order to inform a larger implementation study across different VHA settings.
Methods: LGCC is a novel manual-based intervention that incorporates behavioral change strategies within a Chronic Care Model-based program. It is designed to reduce risk factors for cardiovascular disease (CVD), through improved control of psychiatric symptoms and increased positive health behaviors, as well as improved coordination of physical and mental health care. We will enroll 100 individuals diagnosed with a chronic mental disorder and CVD risk factor who are also receiving care within the VA Ann Arbor Healthcare System mental health clinics, of which 50 will be randomized to LGCC, and 50 randomized to receive usual care. LGCC consists of 1) 10 sessions focused on CVD risk reduction through behavioral change within the context of patients' psychiatric symptoms; 2) participant goal setting in diet and exercise; 3) customized ongoing motivational interviewing (MI)-based patient contacts with a health specialist for 6 months, in addition to 4) strategies to increase provider access and support for behavioral change and medical management. Outcomes will be assessed to determine whether effect sizes are comparable to previously published LGCC randomized controlled trials, and include mental and physical health-related quality of life and long-term (10-year) CVD risk based on the Framingham risk score assessed at 6 months. Additional mixed methods analyses of administrator, consumer and provider interviews to inform further adoption of LGCC will also be completed.
Impact: Serious mental illness is associated with significant disability, decreased quality of life, and a decreased life span. VA patients with SMI die an average of 13-18 years earlier than age and gender matched individuals from the U.S. population, mostly from CVD. Interventions such as LGCC that combine individualized lifestyle coaching with Chronic Care Model principles may lead to the greatest impact on this public health crisis because they address multiple reasons for health disparities, and behavior change is reinforced through improved coordination and continuity of care. If effective, LGCC could be easily disseminated in VA practices and aligned with emerging VHA "T-21" initiatives around veteran-centered care (patient-centered medical home) and behavioral medicine programs that can ultimately improve outcomes for veterans with mental disorders.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI|
|Actual Study Start Date :||October 1, 2010|
|Actual Primary Completion Date :||August 13, 2012|
|Actual Study Completion Date :||March 6, 2015|
Enhanced Usual Care; patients receive care as usual, with additional mailings on wellness newsletter topics
Behavioral: Life Goals Collaborative Care
LGCC consists of 1) 10 sessions focused on CVD risk reduction through behavioral change within the context of patients' psychiatric symptoms; 2) participant goal setting in diet and exercise; 3) customized ongoing motivational interviewing (MI)-based patient contacts with a health specialist for 6 months, in addition to 4) strategies to increase provider access and support for behavioral change and medical management.
- overall health-related quality of life [ Time Frame: 6 months ]
- Framingham risk score [ Time Frame: 6 months ]
- total cholesterol [ Time Frame: 6 months ]
- systolic blood pressure [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244854
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Amy M. Kilbourne, PhD MPH||VA Ann Arbor Healthcare System, Ann Arbor, MI|