Title

Primary Care Intervention Strategy for Anxiety Disorders
Coordinated Anxiety Learning and Management (CALM): Improving Primary Care Anxiety Outcomes
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    buprenorphine ...
  • Study Participants

    1004
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.
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.
Study Started
Jun 30
2006
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Results Posted
May 19
2017
Last Update
May 19
2017

Behavioral Cognitive-behavioral therapy

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.

Drug Psychotropic medication optimization

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,

Behavioral Treatment as Usual

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

CALM Intervention Experimental

Participant choice of: Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization

Treatment as Usual (TAU) Active Comparator

Participants assigned to TAU with their primary care provider (PCP)

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

Summary

CALM Intervention

Treatment as Usual (TAU)

All Events

Event Type Organ System Event Term

BSI-12 (Anxiety and Somatization Subscales)

12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms

CALM Intervention

325.0
number of responders

Treatment as Usual (TAU)

258.0
number of responders

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

Outcome Measure Data Not Reported

Total

1004
Participants

Age, Continuous

43.4
years (Mean)
Standard Deviation: 13.4

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

CALM Intervention

Treatment as Usual (TAU)

Drop/Withdrawal Reasons

CALM Intervention

Treatment as Usual (TAU)