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Primary Care Intervention Strategy for Anxiety Disorders

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00347269
Enrollment
1004
Registered
2006-07-04
Start date
2006-06-30
Completion date
2009-10-31
Last updated
2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder, Panic Disorder, Post-traumatic Stress Disorder, Social Anxiety Disorder

Keywords

Anxiety Disorders, Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Stress, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Mental Health Disorders

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.

Interventions

BEHAVIORALCognitive-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.

DRUGPsychotropic 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.

BEHAVIORALTreatment as Usual

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BSI-12 (Anxiety and Somatization Subscales)Measured at Month 1812 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms

Secondary

MeasureTime frame
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-9Measured at Month 18

Countries

United States

Participant flow

Participants by arm

ArmCount
CALM Intervention
Participants assigned to coordinated anxiety learning and management (CALM)-- CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both. Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose 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. 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.
503
Treatment as Usual (TAU)
Participants assigned to TAU with their primary care provider (PCP) Treatment as Usual: Participants in the control group will receive standard treatment from their PCP.
501
Total1,004

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath23
Overall StudyLost to Follow-up7465
Overall StudyWithdrawal by Subject1838

Baseline characteristics

CharacteristicCALM InterventionTotalTreatment as Usual (TAU)
Age, Continuous43.3 years
STANDARD_DEVIATION 13.2
43.4 years
STANDARD_DEVIATION 13.4
43.7 years
STANDARD_DEVIATION 13.7
Ethnicity (NIH/OMB)
Hispanic or Latino
104 Participants196 Participants92 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
399 Participants808 Participants409 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants9 Participants4 Participants
Race (NIH/OMB)
Asian
11 Participants18 Participants7 Participants
Race (NIH/OMB)
Black or African American
40 Participants97 Participants57 Participants
Race (NIH/OMB)
More than one race
72 Participants133 Participants61 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
40 Participants79 Participants39 Participants
Race (NIH/OMB)
White
333 Participants664 Participants331 Participants
Region of Enrollment
United States
503 participants1004 participants501 participants
Sex: Female, Male
Female
359 Participants714 Participants355 Participants
Sex: Female, Male
Male
144 Participants290 Participants146 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 5033 / 501
other
Total, other adverse events
0 / 5030 / 501
serious
Total, serious adverse events
0 / 5030 / 501

Outcome results

Primary

BSI-12 (Anxiety and Somatization Subscales)

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

Time frame: Measured at Month 18

ArmMeasureValue (NUMBER)
CALM InterventionBSI-12 (Anxiety and Somatization Subscales)325 number of responders
Treatment as Usual (TAU)BSI-12 (Anxiety and Somatization Subscales)258 number of responders
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

Time frame: Measured at Month 18

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026