Primary Care Intervention Strategy for Anxiety Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes

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

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy
* Drug: Psychotropic medication optimization
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM Intervention<br>Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization | Behavioral: Cognitive-behavioral therapy<br>* 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.<br>Drug: Psychotropic medication optimization<br>* 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.<br>* Other names: SSRI, SNRI, Benzodiazepine,;|
| Active Comparator: Treatment as Usual (TAU)<br>Participants assigned to TAU with their primary care provider (PCP) | Behavioral: Treatment as Usual<br>* Participants in the control group will receive standard treatment from their PCP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSI-12 (Anxiety and Somatization Subscales) | 12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms | Measured at Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Measured at Month 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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