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Phase 4 Completed N=1,004 Randomized Single-blind Treatment

Primary Care Intervention Strategy for Anxiety Disorders

Source: ClinicalTrials.gov NCT00347269 ↗
Enrolled (actual)
1,004
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: BSI-12 (Anxiety and Somatization Subscales) — 325; 258 number of responders
◆ Published Evidence
Highly cited
244citations · ~20 / year
Perceived social support mediates anxiety and depressive symptom changes following primary care intervention.
Depression and anxiety · 2014 · Open access · High-confidence link

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.

Linked Publications (5)

  • Perceived social support mediates anxiety and depressive symptom changes following primary care intervention.
    Depression and anxiety · 2014 · 244 citations · Open access · High-confidence link
  • Changes in self-efficacy and outcome expectancy as predictors of anxiety outcomes from the CALM study.
    Depression and anxiety · 2014 · 101 citations · Open access · High-confidence link
  • Treatment engagement and response to CBT among Latinos with anxiety disorders in primary care.
    Journal of consulting and clinical psychology · 2014 · 75 citations · Open access · High-confidence link
  • Trajectories of change in anxiety severity and impairment during and after treatment with evidence-based treatment for multiple anxiety disorders in primary care.
    Depression and anxiety · 2013 · 21 citations · Open access · High-confidence link
  • An examination of the bidirectional relationship between functioning and symptom levels in patients with anxiety disorders in the CALM study.
    Psychological medicine · 2015 · 19 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00347269) and the linked publication. 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. Informational only — not medical advice.

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