This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Primary Care Intervention Strategy for Anxiety Disorders

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington
ClinicalTrials.gov Identifier:
NCT00347269
First received: June 30, 2006
Last updated: April 8, 2017
Last verified: April 2017
June 30, 2006
April 8, 2017
June 2006
October 2009   (Final data collection date for primary outcome measure)
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
Effectiveness of intervention as measured by the BSI-12 (anxiety and somatization subscales)
Complete list of historical versions of study NCT00347269 on ClinicalTrials.gov Archive Site
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 ]
Effectiveness of intervention on functioning outcomes (3-item Sheehan Disability Scales, SF-12) and disorder-specific severity scales as measured by the ASI, PDSS-SR, GADS (modified), SPIN, PCL-C, and the PHQ-9
Not Provided
Not Provided
 
Primary Care Intervention Strategy for Anxiety Disorders
Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
  • Post-traumatic Stress Disorder
  • Generalized Anxiety Disorder
  • Panic Disorder
  • Social Anxiety Disorder
  • 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,
  • Behavioral: Treatment as Usual
    Participants in the control group will receive standard treatment from their PCP.
  • Experimental: CALM Intervention

    Participant choice of:

    Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization

    Interventions:
    • Behavioral: Cognitive-behavioral therapy
    • Drug: Psychotropic medication optimization
  • Active Comparator: Treatment as Usual (TAU)
    Participants assigned to TAU with their primary care provider (PCP)
    Intervention: Behavioral: Treatment as Usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1004
October 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00347269
28630
U01MH057858-05 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS ( Other Identifier: NIMH Program Class Code )
Yes
Not Provided
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/.
Peter Roy-Byrne, University of Washington
University of Washington
National Institute of Mental Health (NIMH)
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
University of Washington
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP