NCT01615458

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

June 6, 2012

Last Update Submit

June 8, 2012

Conditions

Keywords

Care ManagementImplementationInterventionMood Disorders

Outcome Measures

Primary Outcomes (2)

  • Quality of Life

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

  • Decreased Mood Disorder Symptoms

    Change from Baseline in Mood Disorder Symptoms at 6-months

Study Arms (1)

Usual Care

ACTIVE COMPARATOR

Patients will receive their usual care from providers at the clinic.

Behavioral: Chronic Care Model for Mood Disorders

Interventions

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.

Also known as: Life Goals Collaborative Care
Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Palo Alto, California, United States

Location

University of California- San Francisco

San Francisco, California, United States

Location

University of Colorado- Denver

Denver, Colorado, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepressionMood Disorders

Interventions

Chronic Care Model

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care, IntegratedDelivery of Health CarePatient Care ManagementHealth Services Administration

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

July 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations