Primary Care Intervention Strategy for Anxiety Disorders

Phase 4

Completed

• Conditions: Post-traumatic Stress Disorder; Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder
• Interventions: Behavioral: Cognitive-behavioral therapy; Behavioral: Treatment as Usual; Drug: Psychotropic medication optimization

• Registration Number: NCT00347269
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2017-04
• Results First Submitted: 2017-04-08
• Results First Submitted QC: 2017-04-08
• Last Update Submitted: 2017-04-08
• Results First Posted: 2017-05-19
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

Inclusion Criteria

• MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD)
• Speak English or Spanish (English only at UAMS site)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CALM Intervention	Cognitive-behavioral therapy	Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization
CALM Intervention	Psychotropic medication optimization	Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization
Treatment as Usual (TAU)	Treatment as Usual	Participants assigned to TAU with their primary care provider (PCP)

Primary Outcome Measures

Name	Time	Method
BSI-12 (Anxiety and Somatization Subscales)	Measured at Month 18	12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms

Secondary Outcome Measures

Name	Time	Method
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	Measured at Month 18

Trial Locations

Locations (3)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

University of California; 🇺🇸 Los Angeles, California, United States