Phase 4
N=1,004
Primary Care Intervention Strategy for Anxiety Disorders
Post-traumatic Stress Disorder · Generalized Anxiety Disorder · Panic Disorder · Social Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00347269 ↗Enrolled (actual)
1,004
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: BSI-12 (Anxiety and Somatization Subscales) — 325; 258 number of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cognitive-behavioral therapy (Behavioral); Psychotropic medication optimization (Drug); Treatment as Usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BSI-12 (Anxiety and Somatization Subscales) |
325; 258 | — |
| SECONDARY 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 |
— | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT00347269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.