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Trial record 1 of 1 for:    NCT00347269
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Primary Care Intervention Strategy for Anxiety Disorders

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington
ClinicalTrials.gov Identifier:
NCT00347269
First received: June 30, 2006
Last updated: April 8, 2017
Last verified: April 2017
Results First Received: April 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    CALM Intervention   Treatment as Usual (TAU)
STARTED   503   501 
COMPLETED   409   395 
NOT COMPLETED   94   106 
Lost to Follow-up                74                65 
Withdrawal by Subject                18                38 
Death                2                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   CALM Intervention   Treatment as Usual (TAU)   Total 
Overall Participants Analyzed 
[Units: Participants]
 503   501   1004 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.3  (13.2)   43.7  (13.7)   43.4  (13.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      359  71.4%      355  70.9%      714  71.1% 
Male      144  28.6%      146  29.1%      290  28.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   503   501   1004 


  Outcome Measures

1.  Primary:   BSI-12 (Anxiety and Somatization Subscales)   [ Time Frame: Measured at Month 18 ]

2.  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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: roybyrne@u.washington.edu


Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter Roy-Byrne, University of Washington
ClinicalTrials.gov Identifier: NCT00347269     History of Changes
Other Study ID Numbers: 28630
U01MH057858-05 ( US NIH Grant/Contract Award Number )
DSIR 83-ATAS ( Other Identifier: NIMH Program Class Code )
Study First Received: June 30, 2006
Results First Received: April 8, 2017
Last Updated: April 8, 2017