Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Primary Care Intervention Strategy for Anxiety Disorders

This study has been completed.
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington Identifier:
First received: June 30, 2006
Last updated: October 17, 2014
Last verified: October 2014

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Effectiveness of intervention as measured by the BSI-12 (anxiety and somatization subscales) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
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.
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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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


  • Desert Medical Group, Palm Springs CA
  • High Desert Medical Group, Lancaster, CA


  • 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


  • Little Rock Diagnostic Clinic
  • St. Vincent's Family Clinic South
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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
Sponsors and Collaborators
University of Washington
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


Responsible Party: Peter Roy-Byrne, Professor, University of Washington Identifier: NCT00347269     History of Changes
Other Study ID Numbers: U01 MH057858-05, U01MH057858-05, DSIR 83-ATAS
Study First Received: June 30, 2006
Last Updated: October 17, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Anxiety Disorders
Post-traumatic Stress Disorder
Generalized Anxiety Disorder
Panic Disorder
Social Anxiety Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Mental Health Disorders

Additional relevant MeSH terms:
Anxiety Disorders
Panic Disorder
Phobic Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Pathologic Processes
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 25, 2015