Primary Care Intervention Strategy for Anxiety Disorders

April 8, 2017 updated by: Peter Roy-Byrne, University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1004

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72114
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92037-0603
        • University of California
      • Los Angeles, California, United States, 90095-1563
        • University of California
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at Month 18

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michelle G. Craske, PhD, University of California, Los Angeles
  • Study Director: Kristin Bumgardner, BS, 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

April 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28630
  • DSIR 83-ATAS (NIMH Program Class Code)
  • U01MH057858-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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