Life Goals Behavioral Change to Improve Outcomes for Veterans With Serious Mental Illness

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01244854
First received: November 18, 2010
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

Persons with serious mental illness are at increased risk of cardiovascular disease. The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and to get feedback from patients and providers on what is needed to help better coordinate and physical and mental health care of these patients.


Condition Intervention
Bipolar Disorder
Schizophrenia
Major Depressive Disorder
Chronic Affective Disorders
Cardiovascular Disease Risk
Behavioral: Life Goals Collaborative Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • overall health-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Framingham risk score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • total cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: October 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other psychosis, major depressive disorder, or other recurrent depression or affective disorder)
  • Have at least one of the following risk factors for CVD (cardiovascular disease):

Body mass index (BMI) >28 or waist circumference of >35 (women) or >40 (men) inches OR Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia ("high cholesterol") or diabetes or high blood sugar OR Documentation in the medical record of a diagnosis of or treatment for hypertension (defined as documented diagnosis or blood pressure of >140/90 on 2 occasions or prescription for an antihypertensive medication), dyslipidemia (documented diagnosis or LDL>160 or prescription for a lipid-lowering medication) or diabetes mellitus (documented diagnosis or HbA1C >7% or current prescription for oral hypoglycemic therapy)

Exclusion Criteria:

  • Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.
  • Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend sessions due to substantial functional limitations).
  • Active suicidal ideation at time of enrollment (focused interventions are more appropriate for this group)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244854

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Amy M. Kilbourne, PhD MPH VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01244854     History of Changes
Other Study ID Numbers: RRP 10-226
Study First Received: November 18, 2010
Last Updated: December 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic mental disorders
cardiovascular disease
behavior change

Additional relevant MeSH terms:
Bipolar Disorder
Cardiovascular Diseases
Depressive Disorder
Depression
Schizophrenia
Depressive Disorder, Major
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 15, 2014