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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00347269 |
Purpose
This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Stress Disorder Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder |
Behavioral: Cognitive-behavioral therapy Drug: Psychotropic medication optimization Behavioral: Treatment as Usual |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
| Official Title: | Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes |
| Estimated Enrollment: | 1042 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CALM Intervention: Experimental
Participants assigned to coordinated anxiety learning and management (CALM)
|
Behavioral: Cognitive-behavioral therapy
Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Drug: Psychotropic medication optimization
For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
|
|
Treatment as Usual (TAU): Active Comparator
Participants assigned to TAU with their primary care provider (PCP)
|
Behavioral: Treatment as Usual
Participants in the control group will receive standard treatment from their PCP.
|
Anxiety disorders are highly prevalent, distressing, and disabling. Most patients with anxiety disorders who do receive mental health treatment receive it in primary care settings, where the quality of care is generally insufficient. This intervention is geared towards testing the clinical effectiveness of a care-manager assisted chronic disease management program for four common anxiety disorders (post-traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder) in the primary care setting. This approach has been shown to be effective for the treatment of depression.
Participants in this randomized, controlled trial will either be assigned to the control group: treatment-as-usual (TAU) from their primary care provider (PCP); or to the intervention group: CALM (Coordinated Anxiety Learning and Management). Intervention subjects will choose to receive CBT, medication, or both for the treatment of their anxiety. Those who choose CBT will receive it from a study-trained Anxiety Clinical Specialist (ACS) in their respective clinic. For those who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participant's PCP. In this stepped-care design, subject progress will be formally re-evaluated at 8-12 week intervals. If treatment progress is not satisfactory, options include: additional or modified treatment with current modality, switching to the other treatment modality, or adding the other modality. When remission is attained, the ACS will follow-up with participants on a monthly basis to review progress and practice anxiety-reduction strategies. Treatment will continue for up to 12 months. Participants in both study arms will undergo formal baseline and outcome assessment interviews conducted at the 6, 12, and 18 month follow-up time-points.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Eligible subjects must be current patients at one of the participating primary care clinics which include:
University of Washington:
UCLA:
UCSD:
UAMS:
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72114 | |
| United States, California | |
| University of California | |
| Los Angeles, California, United States, 90095-1563 | |
| University of California | |
| La Jolla, California, United States, 92037-0603 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Peter P. Roy-Byrne, MD | University of Washington |
| Principal Investigator: | Cathy D. Sherbourne, PhD | RAND Corporation, Santa Monica, CA |
| Principal Investigator: | Michelle G. Craske, PhD | University of California, Los Angeles, Los Angeles, CA |
| Principal Investigator: | Greer Sullivan, MD, MSPH | University of Arkansas for Medical Sciences, Little Rock, AR |
| Principal Investigator: | Murray B. Stein, MD, MPH | University of California, San Diego, San Diego, CA |
More Information
| Responsible Party: | University of Washington ( Peter Roy-Byrne MD ) |
| Study ID Numbers: | U01 MH057858-05A2, DSIR 83-ATAS |
| Study First Received: | June 30, 2006 |
| Last Updated: | August 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00347269 |
| Health Authority: | United States: Federal Government |
|
Anxiety Disorders Post-traumatic Stress Disorder Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder |
Stress Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Health Disorders |
|
Panic Disorder Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic |
Stress Phobic Disorders Stress Disorders, Traumatic |
|
Pathologic Processes Disease |
