Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
Overview
- Phase
- Phase 4
- Intervention
- Cognitive-behavioral therapy
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- University of Washington
- Enrollment
- 1004
- Locations
- 3
- Primary Endpoint
- BSI-12 (Anxiety and Somatization Subscales)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Peter Roy-Byrne
Professor
University of Washington
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
Arms & Interventions
CALM Intervention
Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization
Intervention: Cognitive-behavioral therapy
CALM Intervention
Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization
Intervention: Psychotropic medication optimization
Treatment as Usual (TAU)
Participants assigned to TAU with their primary care provider (PCP)
Intervention: Treatment as Usual
Outcomes
Primary Outcomes
BSI-12 (Anxiety and Somatization Subscales)
Time Frame: Measured at Month 18
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Secondary Outcomes
- 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)