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Primary Care Intervention Strategy for Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT00347269
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment 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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
Study Start Date : June 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347269


Locations
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
National Institute of Mental Health (NIMH)
Investigators
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other 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 )
First Posted: July 4, 2006    Key Record Dates
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017
Last Verified: April 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:
Anxiety Disorders
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Panic Disorder
Phobia, Social
 Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Phobic Disorders
Psychotropic Drugs