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Bipolar DisorderNCT01615458

Disseminating Evidence-based Mood Disorder Chronic Care Models

A study testing Chronic Care Model for Mood Disorders in people with Bipolar Disorder and Depression, run by University of Michigan at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will determine if a version of the chronic care model for individuals with mood disorders can improve patient health. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder, Depression
What is being tested?
Chronic Care Model for Mood Disorders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesUnited States
Study dates
Jul 2010to May 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently being seen as a patient at the participating site
  • Active diagnosis or treatment plan for Bipolar Disorder (I, II, NOS) or unipolar depression.

Who cannot join

  • No active substance intoxication
  • No acute medical illness or dementia
  • No active suicidal ideation at time of participation

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado- Denver

    Denver, Colorado

  • Stanford University

    Palo Alto, California

  • University of California- San Francisco

    San Francisco, California

Other trials in United States

About this study

This study will determine if a version of the chronic care model for individuals with mood disorders can improve patient health.

Read the detailed description

Chronic mood disorders (notably, bipolar disorder and recurrent unipolar major depressive disorder) are associated with substantial functional impairment, morbidity, economic burden, and mortality. Depression and bipolar disorder are common and are the leading causes of disability worldwide, are associated with substantial costs, and when left untreated, can lead to premature mortality, particularly from suicide. Despite the proliferation of evidence-based guidelines for the treatment of mood disorders, the quality of care and subsequent outcomes remain suboptimal for those suffering from these illnesses.

Collaborative chronic care models (CCMs) have demonstrated efficacy and cost-effectiveness in managing depression and more recently, bipolar disorder. Many of the successful interventions to improve depression treatment and outcomes (e.g., PROSPECT) are based on the Chronic Care Model (CCM). These treatment models combine patient self-management education with ongoing care coordination that is delivered by a care manager, who coordinates care with primary care and mental health providers and facilitates systematic dissemination of guidelines related to mood disorders treatment. In bipolar disorder, CCMs have been found to be cost-neutral, and in depression, cost-effective compared to usual care; hence making business cases for CCMs is promising in both the private and public sectors.

There is mounting demand for CCMs to be implemented for patients across different mental health diagnoses, in order to maximize their reach across diverse clinic populations, and to make them more appealing to healthcare providers, who might be reluctant to hire multiple care managers for different conditions. Unipolar major depressive and bipolar disorders are some of the most common forms of mood disorders treated in specialty mental health as well as in primary care settings. Up to 5.5% and 16.2% of the population have bipolar spectrum disorder and unipolar major depressive disorder, respectively. Based on pilot data from Colorado Access, about a third of patents being treated for depression in routine care settings screened positive for bipolar disorder. Moreover, only a third of patients with unipolar depression remit, which in part might be attributed to under-treatment or inappropriate treatment of bipolar II disorder. However, while CCMs for unipolar depression and bipolar disorder exist, to date they have not been implemented in combination. This project will pilot test a combined CCM that can be applied to patients with unipolar depression or bipolar disorder in specialty mental health or primary care clinics.

This is a one-year pilot randomized controlled trial comparing LGCC to usual care that will involve patients diagnosed with bipolar disorder or unipolar depression who are receiving care in clinics affiliated with NNDC sites or unaffiliated primary care sites. The project will be implemented in three phases: training of existing staff at the local Depression Center clinics, implementation of LGCC, and final outcomes evaluation to inform future studies. Patients from up to four mental health clinics affiliated with NNDC sites (University of Michigan Depression Center, Stanford University Depression Center, University of Colorado-Denver Depression Center, and University of California-San Francisco Depression Center) and 1 primary care setting (Packard Community Health, Ann Arbor, MI) will be randomized to receive LGCC or standard care as usual (32 per site; total 160 patients). Randomization will be stratified by diagnosis (unipolar depression or bipolar disorder). At the end of the pilot study, patients not randomized to receive LGCC will be offered the intervention. An additional 10 providers will be asked to complete surveys from their site (total n=50), for a grand total of n=210 participants (160 patients and 50 providers).

Being tested
Chronic Care Model for Mood Disorders
Keywords
Care Management, Implementation, Intervention, Mood Disorders
Medical subject headings
Bipolar Disorder, Depression, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chronic Care Model for Mood DisordersBehavioural

    Also called Life Goals Collaborative Care

    CCM includes (1) patient self-management enhancement focused on promoting healthy lifestyles as coping strategies to minimize the negative impact of depressive, manic, and other affective symptoms; (2) provider support for evidence-based decision-making; and (3) enhanced access and continuity for anticipatory rather than reactive care.

Study groups in NCT01615458
Study groupRoleWhat they receive
Usual CareActive comparatorPatients will receive their usual care from providers at the clinic.
Receives: Behavioral: Chronic Care Model for Mood Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

    Measured: Change in From Baseline in Quality of Life at 6-months.

  2. Decreased Mood Disorder Symptoms

    Measured: Change from Baseline in Mood Disorder Symptoms at 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2012 (estimated)
  2. Study startJul 2010
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01615458
Sponsor's protocol ID
G009567
Status last verified
Jun 2012
First submitted
6 Jun 2012
Last updated
11 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Chronic Care Model for Mood Disorders in people with Bipolar Disorder and Depression, run by University of Michigan at 4 sites 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 2 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 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Quality of Life (time frame: Change in From Baseline in Quality of Life at 6-months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 11 Jun 2012.

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Clinical Trial NCT01615458 | AzTrials