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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

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

NCT ID

NCT00347269

First Posted

June 30, 2006

Last Updated

April 8, 2017

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

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

Eligibility Criteria

Overall Study Officials: