Bipolar DisorderNCT01487668
Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
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 (SMI) are at increased risk of cardiovascular disease (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and improve mental health and physical health-related quality of life, as well as to get feedback from… 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
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Persons with serious mental illness (SMI) are at increased risk of cardiovascular disease (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and improve mental health and physical health-related quality of life, as well as to get feedback from patients and providers on what is needed to help better coordinate the physical and mental health care of these patients.
Read the detailed description
Background: VA patients with serious mental illnesses (SMI- e.g., schizophrenia, bipolar disorder) die an average of 13-18 years earlier compared to the general U.S. population, mostly from cardiovascular disease (CVD). Increased risk of CVD and related risk factors in persons with SMI is attributed to patient, provider, and system-level barriers including unhealthy behaviors exacerbated by mental health-related symptoms and barriers to access and continuity of care between physical and mental health services.
Objectives: The primary aim of this randomized controlled effectiveness trial (RCT) is to determine whether VA patients with SMI receiving Life Goals Collaborative Care (LGCC), a program that combines customized behavioral change strategies with chronic care management for SMI will experience, within 12 months: a) improved medical outcomes (e.g., reduced CVD risk factors, improved physical health-related quality of life), b) improved mental health outcomes, including reduced psychiatric symptoms or improved mental health-related quality of life or c) improved health behaviors, compared to VA patients with SMI receiving enhanced treatment as usual (i.e., dissemination of health behavior change materials in addition to standard VA medical and psychiatric care). Secondary aims that will inform further implementation of LGCC will be to assess utilization and cost differences of LGCC versus treatment as usual, determine the patient factors associated with LGCC treatment response, and identify the organizational factors associated with LGCC implementation.
Methods: LGCC is a groundbreaking psychosocial and behavior change intervention that is based on the Chronic Care Model (CCM) and consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages. The investigators will enroll individuals diagnosed with SMI and a CVD risk factor who are receiving care within the VA Ann Arbor Healthcare System mental health clinic, and who will be randomized to receive LGCC or enhanced treatment as usual. Key outcomes include changes in CVD risk factors (e.g., blood pressure, BMI), psychiatric symptoms, health-related quality of life, health behaviors (e.g., physical activity), and inpatient and outpatient use assessed at 6 and 12 months.
Impact: This study addresses VA HSR\&D research priorities related to mental health and care of complex, chronic conditions, and is consistent with the priorities of the VHA's Office of Mental Health Services (Patient Care Services), 10NC, and the National Center for Health Promotion and Disease Prevention. Serious mental illness (SMI) is associated with significant disability, decreased quality of life, and a decreased life span. The VA is undergoing two major quality improvement initiatives: the Patient-Aligned Care Team (PACT), which involves enhanced access and continuity of care based on Chronic Care Model (CCM) principles, and dissemination of behavioral medicine programs. However, to date these programs have not been fully adapted to address gaps in quality or outcomes of care for Veterans with SMI. Findings from this RCT will inform ongoing VA transformational initiatives around systems redesign and behavioral medicine programs for Veterans with SMI and determine whether a customized CCM-behavioral medicine strategy is most effective in improving outcomes for this vulnerable group.
- Conditions
- Bipolar Disorder, Schizophrenia, Major Depressive Disorder, Schizoaffective Disorder, 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, Psychotic Disorders, 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 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Usual Care | No intervention | Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist. |
| Arm 2 - Life Goals Collaborative Care | Experimental | Not described Receives: Behavioral: Life Goals Collaborative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Health-related Quality of Life
The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.
Measured: 12 months
Secondary outcomes (1)
Improved Mental Health-related Quality of Life
Change in SF-12 mental health scores from baseline to 12 months. The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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
- 304 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
- NCT01487668
- Sponsor's protocol ID
- IIR 10-340
- Status last verified
- Dec 2015
- First submitted
- 21 Nov 2011
- Last updated
- 22 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kilbourne AM, Goodrich DE, Lai Z, Post EP, Schumacher K, Nord KM, Bramlet M, Chermack S, Bialy D, Bauer MS. Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT). J Clin Psychiatry. 2013 Jul;74(7):e655-62. doi: 10.4088/JCP.12m08082.
PubMed 23945460O'Donnell AN, Williams M, Kilbourne AM. Overcoming roadblocks: current and emerging reimbursement strategies for integrated mental health services in primary care. J Gen Intern Med. 2013 Dec;28(12):1667-72. doi: 10.1007/s11606-013-2496-z. Epub 2013 Jun 4.
PubMed 23733375Goodrich DE, Kilbourne AM, Nord KM, Bauer MS. Mental health collaborative care and its role in primary care settings. Curr Psychiatry Rep. 2013 Aug;15(8):383. doi: 10.1007/s11920-013-0383-2.
PubMed 23881714Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039.
PubMed 24129806Kilbourne 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 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders
- ClinicalTrials.gov ID
- NCT01487668
- Acronym / sponsor ID
- IIR 10-340
- Conditions
- Bipolar Disorder, Schizophrenia, Major Depressive Disorder, Schizoaffective Disorder, Cardiovascular Disease Risk
- Keywords
- chronic mental disorders, cardiovascular disease, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Posted 22 Jan 2016
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 (SMI) are at increased risk of cardiovascular disease (CVD). The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and improve mental health and physical health-related quality of life, as well as to get feedback from patients and providers on what is needed to help better coordinate the physical and mental health care of these patients.
Detailed description
Background: VA patients with serious mental illnesses (SMI- e.g., schizophrenia, bipolar disorder) die an average of 13-18 years earlier compared to the general U.S. population, mostly from cardiovascular disease (CVD). Increased risk of CVD and related risk factors in persons with SMI is attributed to patient, provider, and system-level barriers including unhealthy behaviors exacerbated by mental health-related symptoms and barriers to access and continuity of care between physical and mental health services.
Objectives: The primary aim of this randomized controlled effectiveness trial (RCT) is to determine whether VA patients with SMI receiving Life Goals Collaborative Care (LGCC), a program that combines customized behavioral change strategies with chronic care management for SMI will experience, within 12 months: a) improved medical outcomes (e.g., reduced CVD risk factors, improved physical health-related quality of life), b) improved mental health outcomes, including reduced psychiatric symptoms or improved mental health-related quality of life or c) improved health behaviors, compared to VA patients with SMI receiving enhanced treatment as usual (i.e., dissemination of health behavior change materials in addition to standard VA medical and psychiatric care). Secondary aims that will inform further implementation of LGCC will be to assess utilization and cost differences of LGCC versus treatment as usual, determine the patient factors associated with LGCC treatment response, and identify the organizational factors associated with LGCC implementation.
Methods: LGCC is a groundbreaking psychosocial and behavior change intervention that is based on the Chronic Care Model (CCM) and consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages. The investigators will enroll individuals diagnosed with SMI and a CVD risk factor who are receiving care within the VA Ann Arbor Healthcare System mental health clinic, and who will be randomized to receive LGCC or enhanced treatment as usual. Key outcomes include changes in CVD risk factors (e.g., blood pressure, BMI), psychiatric symptoms, health-related quality of life, health behaviors (e.g., physical activity), and inpatient and outpatient use assessed at 6 and 12 months.
Impact: This study addresses VA HSR\&D research priorities related to mental health and care of complex, chronic conditions, and is consistent with the priorities of the VHA's Office of Mental Health Services (Patient Care Services), 10NC, and the National Center for Health Promotion and Disease Prevention. Serious mental illness (SMI) is associated with significant disability, decreased quality of life, and a decreased life span. The VA is undergoing two major quality improvement initiatives: the Patient-Aligned Care Team (PACT), which involves enhanced access and continuity of care based on Chronic Care Model (CCM) principles, and dissemination of behavioral medicine programs. However, to date these programs have not been fully adapted to address gaps in quality or outcomes of care for Veterans with SMI. Findings from this RCT will inform ongoing VA transformational initiatives around systems redesign and behavioral medicine programs for Veterans with SMI and determine whether a customized CCM-behavioral medicine strategy is most effective in improving outcomes for this vulnerable group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Usual Care | No intervention | –Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist. |
| Arm 2 - Life Goals Collaborative Care | Experimental | Behavioral: Life Goals Collaborative Care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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):
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 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages. | Behavioural | Arm 2 - Life Goals Collaborative Care |
Primary outcome
Physical Health-related Quality of Life
Time frame: 12 months
The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.
1 secondary outcome
Improved Mental Health-related Quality of Life
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23945460Kilbourne AM, Goodrich DE, Lai Z, Post EP, Schumacher K, Nord KM, Bramlet M, Chermack S, Bialy D, Bauer MS. Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT). J Clin Psychiatry. 2013 Jul;74(7):e655-62. doi: 10.4088/JCP.12m08082.
- Results publication: PubMed 23733375O'Donnell AN, Williams M, Kilbourne AM. Overcoming roadblocks: current and emerging reimbursement strategies for integrated mental health services in primary care. J Gen Intern Med. 2013 Dec;28(12):1667-72. doi: 10.1007/s11606-013-2496-z. Epub 2013 Jun 4.
- Results publication: PubMed 23881714Goodrich DE, Kilbourne AM, Nord KM, Bauer MS. Mental health collaborative care and its role in primary care settings. Curr Psychiatry Rep. 2013 Aug;15(8):383. doi: 10.1007/s11920-013-0383-2.
- Results publication: PubMed 24129806Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039.
- 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 5 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 22 Jan 2016. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Health-related Quality of Life (time frame: 12 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 NCT01487668, which also lists 6 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 22 Jan 2016.