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Completed

NCT Number: NCT00347269

Primary Care Intervention Strategy for Anxiety Disorders

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

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.

Psychotropic medication optimization

Drug

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.

Other names: SSRI, SNRI, Benzodiazepine,

Treatment as Usual

Behavioral

Participants in the control group will receive standard treatment from their PCP.

Primary outcomes

  1. 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

  1. 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

    Time frame: Measured at Month 18

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2006
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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