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Re-Engineering Systems for the Primary Care Treatment for PTSD (RESPECT-PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00373698
First received: September 6, 2006
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: July 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stress Disorders, Posttraumatic
Depression
Intervention: Behavioral: Three Component Model of Collaborative Care

  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
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Reporting Groups
  Description
Three Component Model of Collaborative Care and Usual Care Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's "Usual Care" is at the VA provider's discretion and could include referral to mental health specialty care.specialty care.
Usual Care Participants randomized to "Usual Care" received care at the VA provider's discretion and could include referral to mental health specialty care.

Participant Flow:   Overall Study
    Three Component Model of Collaborative Care and Usual Care     Usual Care  
STARTED     96     99  
COMPLETED     85     99  
NOT COMPLETED     11     0  



  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.
To be included, subjects had to meet diagnostic criteria for PTSD, have regular access to a telephone, and speak English. Exclusion criteria were cognitive impairment, history of psychosis or mania, prominent current suicidal ideation, current substance dependence, and current engagement in mental health treatment

Reporting Groups
  Description
Three Component Model Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Usual Care Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Total Total of all reporting groups

Baseline Measures
    Three Component Model     Usual Care     Total  
Number of Participants  
[units: participants]
  96     99     195  
Age, Customized  
[units: years]
Mean ( Full Range )
     
Age, >=18     46.1  
  ( NA to NA ) [2]
  44.4  
  ( NA to NA ) [3]
  NA  
  ( NA to NA ) [1]
Gender  
[units: participants]
     
Female     7     10     17  
Male     89     89     178  
Region of Enrollment  
[units: participants]
     
United States     96     99     195  
PTSD symptom severity (used Posttraumatic Diagnostic Scale (PDS)) [4]
[units: units on a scale]
Mean ± Standard Deviation
  33.2  ± 8.3     34.0  ± 9.7     NA  ± NA [5]
Depression (Hopkins Symptom Checklist-20) [6]
[units: units on a scale]
Mean ± Standard Deviation
  1.98  ± 0.69     2.06  ± 0.78     NA  ± NA [5]
SF-36 Mental Component [7]
[units: units on a scale]
Mean ± Standard Deviation
  33.8  ± 8.8     32.7  ± 8.1     NA  ± NA [8]
SF-36 Physical Component [9]
[units: units on a scale]
Mean ± Standard Deviation
  42.2  ± 13.0     43.4  ± 12.6     NA  ± NA [8]
[1] The data are locked and the total can not be calculated.
[2] 43.1-49.1 (95% confidence interval)
[3] 41.3-47.5 (95% confidence interval)
[4] The PDS yields a total severity score (ranging from 0 to 51, where 0 is the best and 51 is the worst) that largely reflects the frequency of the 17 symptoms of PTSD. 17 symptoms of PTSD are rated individually on a scale from 0 to 3, with 3 being the highest. Total severity score is calculated by adding the number from each individual symptom. A PDS Profile Report also provides a preliminary determination of DSM-IV PTSD diagnostic status, a count of the number of symptoms endorsed, a rating of symptom severity, and a rating of the level of impairment of functioning.
[5] The data are locked and can not be calculated
[6] Depression severity (ranging 0-4) was measured with the Hopkins Symptom Checklist-20. This self-assessment measure consists of 20 questions with possible scores ranging from 0 to 4, with higher scores indicating worse symptoms. Means and the standard deviations of the 20 questions are presented with higher scores indicating worse depression.
[7] SF-36 Mental Component is measured as part of SF-36 Health Survey. Scores can range from 0 (poorest possible health ) to 100 (highest possible health).
[8] The data are locked and can not be calculated.
[9] SF-36 Physical Component is measured as part of SF-36 Health Survey. Scores can range from 0 (poorest possible health ) to 100 (highest possible health).



  Outcome Measures
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1.  Primary:   PTSD Symptom Severity   [ Time Frame: 3 and 6 months after initial assessment ]

2.  Secondary:   Depression   [ Time Frame: 3 and 6 months after initial assessment ]

3.  Secondary:   SF-36 Mental Component   [ Time Frame: 3 and 6 months after initial assessment ]

4.  Secondary:   SF-36 Physical Component   [ Time Frame: 3 and 6 months after initial assessment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Paula Schnurr and Dr. Mathew Friedman
Organization: VA Medical Center, White River Junction, VT
phone: 802-296-5132
e-mail: Paula.Schnurr@va.gov; Matthew.Friedman@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00373698     History of Changes
Other Study ID Numbers: IAC 06-073
Study First Received: September 6, 2006
Results First Received: July 31, 2014
Last Updated: November 3, 2014
Health Authority: United States: Federal Government