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Primary Care Intervention Strategy for Anxiety Disorders
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Purpose
| 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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes |
- BSI-12 (Anxiety and Somatization Subscales) [ Time Frame: Measured at Month 18 ]12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
- Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9 [ Time Frame: Measured at Month 18 ]
| Enrollment: | 1004 |
| Study Start Date: | June 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CALM Intervention
Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization |
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.
Other Name: SSRI, SNRI, Benzodiazepine,
|
|
Active Comparator: Treatment as Usual (TAU)
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.
|
Detailed Description:
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
- Speak English or Spanish (English only at UAMS site)
Exclusion Criteria:
- Diagnosis of Bipolar 1
- Drug and alcohol dependence; or abuse of any substance other than marijuana and alcohol
- Acute suicidality or homicidality
Eligible subjects must be current patients at one of the participating primary care clinics which include:
University of Washington:
- Harborview's Adult Medicine Clinic
- Harborview's Family Medicine Clinic
- UWMC's General Internal Medicine Clinic at Roosevelt Clinic
- PSNHC's 45th Street Clinic
- Country Doctor Community Clinic
- Carolyn Downs Family Medical Center
UCLA:
- Desert Medical Group, Palm Springs CA
- High Desert Medical Group, Lancaster, CA
UCSD:
- Kaiser Permanente, Bonita Medical Offices
- Kaiser Permanente, Otay Mesa Outpatient Medical Center
- UCSD Medical Center, Scripps Ranch Medical Office
- UCSD Medical Center, Fourth and Lewis Medical Office
- UCSD Medical Center, Perlman Ambulatory Care Center
- Sharp Rees-Stealy Medical Group, El Cajon
- Sharp Rees-Stealy Medical Group, Mira Mesa
UAMS:
- UAMS UPMG
- Little Rock Diagnostic Clinic
- St. Vincent's Family Clinic South
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00347269
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72114 | |
| United States, California | |
| University of California | |
| La Jolla, California, United States, 92037-0603 | |
| University of California | |
| Los Angeles, California, United States, 90095-1563 | |
| 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 |
| 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 |
| Study Director: | Kristin Bumgardner, BS | University of Washington |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Peter Roy-Byrne, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00347269 History of Changes |
| Other Study ID Numbers: |
28630 U01MH057858-05 ( U.S. NIH Grant/Contract ) DSIR 83-ATAS ( Other Identifier: NIMH Program Class Code ) |
| Study First Received: | June 30, 2006 |
| Results First Received: | April 8, 2017 |
| Last Updated: | April 8, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Limited access datasets are available through the National Database for Clinical Trials Related to Mental Illness (NDCT), part of the NIMH Data Archive: https://data-archive.nimh.nih.gov/ndct/. |
Keywords provided by Peter Roy-Byrne, University of Washington:
|
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 |
Additional relevant MeSH terms:
|
Disease Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Panic Disorder |
Phobic Disorders Pathologic Processes Mental Disorders Trauma and Stressor Related Disorders Psychotropic Drugs |
ClinicalTrials.gov processed this record on July 19, 2017