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Primary Care Intervention Strategy for Anxiety Disorders

Primary Purpose

Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Psychotropic medication optimization
Treatment as Usual
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • University of California
  • University of California
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CALM Intervention

Treatment as Usual (TAU)

Arm Description

Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization

Participants assigned to TAU with their primary care provider (PCP)

Outcomes

Primary Outcome Measures

BSI-12 (Anxiety and Somatization Subscales)
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms

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

Full Information

First Posted
June 30, 2006
Last Updated
April 8, 2017
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00347269
Brief Title
Primary Care Intervention Strategy for Anxiety Disorders
Official Title
Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CALM Intervention
Arm Type
Experimental
Arm Description
Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Participants assigned to TAU with their primary care provider (PCP)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Psychotropic medication optimization
Other Intervention Name(s)
SSRI, SNRI, Benzodiazepine,
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Participants in the control group will receive standard treatment from their PCP.
Primary Outcome Measure Information:
Title
BSI-12 (Anxiety and Somatization Subscales)
Description
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Time Frame
Measured at Month 18
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter P. Roy-Byrne, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathy D. Sherbourne, PhD
Organizational Affiliation
RAND Corporation, Santa Monica, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle G. Craske, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Greer Sullivan, MD, MSPH
Organizational Affiliation
University of Arkansas for Medical Sciences, Little Rock, AR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murray B. Stein, MD, MPH
Organizational Affiliation
University of California, San Diego, San Diego, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin Bumgardner, BS
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114
Country
United States
Facility Name
University of California
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0603
Country
United States
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1563
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/.
Citations:
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Primary Care Intervention Strategy for Anxiety Disorders

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