Life Goals Behavioral Change to Improve Outcomes for Veterans With Serious Mental Illness
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 18, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2015
CompletedJune 6, 2017
June 1, 2017
1.9 years
November 18, 2010
June 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall health-related quality of life
6 months
Secondary Outcomes (3)
Framingham risk score
6 months
total cholesterol
6 months
systolic blood pressure
6 months
Study Arms (1)
Arm 1
OTHEREnhanced Usual Care; patients receive care as usual, with additional mailings on wellness newsletter topics
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105, United States
Related Publications (3)
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.
PMID: 20381155RESULTKilbourne 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.
PMID: 25083802RESULTKilbourne 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.
PMID: 27780336DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy M. Kilbourne, PhD MPH
VA Ann Arbor Healthcare System, Ann Arbor, MI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2010
First Posted
November 19, 2010
Study Start
October 1, 2010
Primary Completion
August 13, 2012
Study Completion
March 6, 2015
Last Updated
June 6, 2017
Record last verified: 2017-06