Primary Care Intervention Strategy for Anxiety Disorders

University of Washington

Status and phase: Completed; Phase 4

Conditions: Post-traumatic Stress Disorder; Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Treatments: Behavioral: Cognitive-behavioral therapy; Behavioral: Treatment as Usual; Drug: Psychotropic medication optimization

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00347269

DSIR 83-ATAS

28630

U01MH057858-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,004 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,004 participants in 2 patient groups

CALM Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive-behavioral therapy

Drug: Psychotropic medication optimization

Treatment as Usual (TAU)

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment as Usual