Bipolar DisorderNCT01244854
Life Goals Behavioral Change to Improve Outcomes for Veterans With Serious Mental Illness
A study testing Life Goals Collaborative Care in people with Bipolar Disorder and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bipolar Disorder, Schizophrenia, Major Depressive Disorder
- What is being tested?
- Life Goals Collaborative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2010to 6 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI
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.
Read the 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.
- Conditions
- Bipolar Disorder, Schizophrenia, Major Depressive Disorder, Chronic Affective Disorders, Cardiovascular Disease Risk
- Being tested
- Life Goals Collaborative Care
- Keywords
- chronic mental disorders, cardiovascular disease, behavior change
- Medical subject headings
- Bipolar Disorder, Schizophrenia, Depressive Disorder, Major, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Goals Collaborative CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Enhanced Usual Care; patients receive care as usual, with additional mailings on wellness newsletter topics Receives: Behavioral: Life Goals Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall health-related quality of life
Measured: 6 months
Secondary outcomes (3)
Framingham risk score
Measured: 6 months
total cholesterol
Measured: 6 months
systolic blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study start1 Oct 2010
- Primary completion13 Aug 2012
- Study completion6 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy M. Kilbourne, PhD MPH, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244854
- Sponsor's protocol ID
- RRP 10-226
- Status last verified
- Jun 2017
- First submitted
- 18 Nov 2010
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20381155Kilbourne 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.
PubMed 25083802Kilbourne 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.
PubMed 27780336
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI
- ClinicalTrials.gov ID
- NCT01244854
- Acronym / sponsor ID
- RRP 10-226
- Conditions
- Bipolar Disorder, Schizophrenia, Major Depressive Disorder, Chronic Affective Disorders, Cardiovascular Disease Risk
- Keywords
- chronic mental disorders, cardiovascular disease, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 13 Aug 2012 (actual)
- Study completion
- 6 Mar 2015 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Life Goals Collaborative CareEnhanced Usual Care; patients receive care as usual, with additional mailings on wellness newsletter topics |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Goals Collaborative CareLGCC 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. | Behavioural | Arm 1 |
Primary outcome
overall health-related quality of life
Time frame: 6 months
3 secondary outcomes
Framingham risk score
Time frame: 6 months
total cholesterol
Time frame: 6 months
systolic blood pressure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Results publication: PubMed 20381155Goodrich 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 publication: PubMed 25083802Kilbourne 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.
- Derived from this study: PubMed 27780336Kilbourne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy M. Kilbourne, PhD MPH principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Goals Collaborative Care in people with Bipolar Disorder and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall health-related quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01244854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.