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

Primary Purpose

Bipolar Disorder, Schizophrenia, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Life Goals Collaborative Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bipolar Disorder focused on measuring chronic mental disorders, cardiovascular disease, behavior change

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Enhanced Usual Care; patients receive care as usual, with additional mailings on wellness newsletter topics

Outcomes

Primary Outcome Measures

overall health-related quality of life

Secondary Outcome Measures

Framingham risk score
total cholesterol
systolic blood pressure

Full Information

First Posted
November 18, 2010
Last Updated
June 2, 2017
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01244854
Brief Title
Life Goals Behavioral Change to Improve Outcomes for Veterans With Serious Mental Illness
Official Title
Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2010 (Actual)
Primary Completion Date
August 13, 2012 (Actual)
Study Completion Date
March 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Schizophrenia, Major Depressive Disorder, Chronic Affective Disorders, Cardiovascular Disease Risk
Keywords
chronic mental disorders, cardiovascular disease, behavior change

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Enhanced Usual Care; patients receive care as usual, with additional mailings on wellness newsletter topics
Intervention Type
Behavioral
Intervention Name(s)
Life Goals Collaborative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall health-related quality of life
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Framingham risk score
Time Frame
6 months
Title
total cholesterol
Time Frame
6 months
Title
systolic blood pressure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M. Kilbourne, PhD MPH
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20381155
Citation
Goodrich DE, Lai Z, Lasky E, Burghardt AR, Kilbourne AM. Access to weight loss counseling services among patients with bipolar disorder. J Affect Disord. 2010 Oct;126(1-2):75-9. doi: 10.1016/j.jad.2010.02.138. Epub 2010 Apr 8.
Results Reference
result
PubMed Identifier
25083802
Citation
Kilbourne AM, Bramlet M, Barbaresso MM, Nord KM, Goodrich DE, Lai Z, Post EP, Almirall D, Verchinina L, Duffy SA, Bauer MS. SMI life goals: description of a randomized trial of a collaborative care model to improve outcomes for persons with serious mental illness. Contemp Clin Trials. 2014 Sep;39(1):74-85. doi: 10.1016/j.cct.2014.07.007. Epub 2014 Jul 30.
Results Reference
result
PubMed Identifier
27780336
Citation
Kilbourne AM, Barbaresso MM, Lai Z, Nord KM, Bramlet M, Goodrich DE, Post EP, Almirall D, Bauer MS. Improving Physical Health in Patients With Chronic Mental Disorders: Twelve-Month Results From a Randomized Controlled Collaborative Care Trial. J Clin Psychiatry. 2017 Jan;78(1):129-137. doi: 10.4088/JCP.15m10301.
Results Reference
derived

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

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