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Trial record 1 of 1 for:    23290323 [PUBMED-IDS]
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Primary Care Intervention Strategy for Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT00347269
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post-traumatic Stress Disorder
Generalized Anxiety Disorder
Panic Disorder
Social Anxiety Disorder
Interventions Behavioral: Cognitive-behavioral therapy
Drug: Psychotropic medication optimization
Behavioral: Treatment as Usual
Enrollment 1004
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CALM Intervention Treatment as Usual (TAU)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 503 501
Completed 409 395
Not Completed 94 106
Reason Not Completed
Lost to Follow-up             74             65
Withdrawal by Subject             18             38
Death             2             3
Arm/Group Title CALM Intervention Treatment as Usual (TAU) Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 503 501 1004
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 503 participants 501 participants 1004 participants
43.3  (13.2) 43.7  (13.7) 43.4  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 503 participants 501 participants 1004 participants
Female
359
  71.4%
355
  70.9%
714
  71.1%
Male
144
  28.6%
146
  29.1%
290
  28.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 503 participants 501 participants 1004 participants
Hispanic or Latino
104
  20.7%
92
  18.4%
196
  19.5%
Not Hispanic or Latino
399
  79.3%
409
  81.6%
808
  80.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 503 participants 501 participants 1004 participants
American Indian or Alaska Native
5
   1.0%
4
   0.8%
9
   0.9%
Asian
11
   2.2%
7
   1.4%
18
   1.8%
Native Hawaiian or Other Pacific Islander
2
   0.4%
2
   0.4%
4
   0.4%
Black or African American
40
   8.0%
57
  11.4%
97
   9.7%
White
333
  66.2%
331
  66.1%
664
  66.1%
More than one race
72
  14.3%
61
  12.2%
133
  13.2%
Unknown or Not Reported
40
   8.0%
39
   7.8%
79
   7.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 503 participants 501 participants 1004 participants
503 501 1004
1.Primary Outcome
Title BSI-12 (Anxiety and Somatization Subscales)
Hide Description 12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Time Frame Measured at Month 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CALM Intervention Treatment as Usual (TAU)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 503 501
Measure Type: Number
Unit of Measure: number of responders
325 258
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Measured at Month 18
Outcome Measure Data Not Reported
Time Frame 18 months
Adverse Event Reporting Description As all treatments were part of standard care, both CBT and psychotropic medications routinely employed in clinical settings, no specific AE assessments were performed as would be done in clinical drug trials.
 
Arm/Group Title CALM Intervention Treatment as Usual (TAU)
Hide Arm/Group Description

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.

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.

All-Cause Mortality
CALM Intervention Treatment as Usual (TAU)
Affected / at Risk (%) Affected / at Risk (%)
Total   2/503 (0.40%)   3/501 (0.60%) 
Show Serious Adverse Events Hide Serious Adverse Events
CALM Intervention Treatment as Usual (TAU)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/503 (0.00%)   0/501 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CALM Intervention Treatment as Usual (TAU)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/503 (0.00%)   0/501 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Roy-Byrne MD Professor of Psychiatry
Organization: University of Washington
Phone: 206-313-8504
Publications of Results:
Responsible Party: Peter Roy-Byrne, University of Washington
ClinicalTrials.gov Identifier: NCT00347269     History of Changes
Other Study ID Numbers: 28630
U01MH057858-05 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS ( Other Identifier: NIMH Program Class Code )
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: April 8, 2017
Results First Posted: May 19, 2017
Last Update Posted: May 19, 2017