Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00127413
First received: August 3, 2005
Last updated: March 23, 2015
Last verified: March 2015
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pain
Posttraumatic Stress Disorder
Interventions: Behavioral: Cognitive Behavioral Therapy - Pain
Behavioral: Cognitive Behavioral Therapy-Integrated
Behavioral: Cognitive Processing Therapy - PTSD
Behavioral: Treat 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
If it was determined during the assessment that a participant did not meet criteria for PTSD or would be excluded based on pre-determined exclusion criteria (e.g., substance use, no pain, psychosis) then the assessment was terminated and additional study related data was not collected. This was done to reduce unnecessary participant burden.

Reporting Groups
  Description
Cognitive Behavioral Therapy - Pain Cognitive Behavioral Therapy targeting chronic pain
Cognitive Processing Therapy - PTSD Cognitive processing therapy for PTSD
Cognitive Behavioral Therapy - Integrated Integrated treatment for comorbid chronic pain and PTSD
Treat as Usual Participants received care for pain and PTSD as usual from their primary care provider.

Participant Flow:   Overall Study
    Cognitive Behavioral Therapy - Pain     Cognitive Processing Therapy - PTSD     Cognitive Behavioral Therapy - Integrated     Treat as Usual  
STARTED     12     10     13     7  
COMPLETED     6     6     5     5  
NOT COMPLETED     6     4     8     2  
Lost to Follow-up                 6                 4                 8                 2  



  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
Cognitive Behavioral Therapy - Pain Cognitive Behavioral Therapy targeting chronic pain
Cognitive Processing Therapy-PTSD Cognitive processing therapy for PTSD
Cognitive Behavioral Therapy-Integrated Integrated treatment for comorbid chronic pain and PTSD
Treat as Usual Participants received care for pain and PTSD as usual from their primary care provider.
Total Total of all reporting groups

Baseline Measures
    Cognitive Behavioral Therapy - Pain     Cognitive Processing Therapy-PTSD     Cognitive Behavioral Therapy-Integrated     Treat as Usual     Total  
Number of Participants  
[units: participants]
  12     10     13     7     42  
Age  
[units: years]
Mean (Standard Deviation)
  54.13  (5.6)     49.20  (5.27)     54.18  (7.82)     52.40  (4.67)     52.80  (6.23)  
Gender  
[units: participants]
         
Female     1     3     3     1     8  
Male     11     7     10     6     34  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     1     0     1  
Black or African American     5     3     3     2     13  
White     6     6     8     5     25  
More than one race     1     1     1     0     3  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     12     10     13     7     42  



  Outcome Measures

1.  Primary:   Clinician Administered Assessment of PTSD   [ Time Frame: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up ]


  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
Failure to engage in treatment, failure to complete treatment in a timely manner due to missed treatment sessions, and difficulty with compliance with treatment session recommendations led to lower completion rates


  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: John D. Otis
Organization: VA Boston Healthcare System
phone: 8573645740
e-mail: john.otis@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00127413     History of Changes
Other Study ID Numbers: D3322-R
Study First Received: August 3, 2005
Results First Received: November 17, 2014
Last Updated: March 23, 2015
Health Authority: United States: Federal Government