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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120067
First Posted: May 10, 2010
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: October 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Stress Disorders, Post-Traumatic
Interventions: Behavioral: Intensive Treatment
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
Intensive Treatment

Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain

Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.

Treatment as Usual

Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD

Treatment as Usual: Treatment as Usual.


Participant Flow:   Overall Study
    Intensive Treatment   Treatment as Usual
STARTED   12   11 
COMPLETED   7   10 
NOT COMPLETED   5   1 
Lost to Follow-up                3                1 
fail to engage >3 sessions                2                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.
No text entered.

Reporting Groups
  Description
Intensive Treatment

Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain

Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.

Treatment as Usual

Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD

Treatment as Usual: Treatment as Usual.

Total Total of all reporting groups

Baseline Measures
   Intensive Treatment   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   11   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.75  (10.39)   52.09  (10.64)   49.79  (10.274) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      2  18.2%      2   8.7% 
Male      12 100.0%      9  81.8%      21  91.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White/Caucasian   9   9   18 
African American   2   2   4 
Hispanic   1   0   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   12   11   23 


  Outcome Measures

1.  Primary:   McGill Pain Questionnaire   [ Time Frame: 6 months ]


  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
Small N due to challenges associated with recruitment.


  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 Otis
Organization: VA Boston Healthcare System
phone: 857-364-5740
e-mail: john.otis@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01120067     History of Changes
Other Study ID Numbers: D6281-I
First Submitted: April 30, 2010
First Posted: May 10, 2010
Results First Submitted: October 24, 2016
Results First Posted: December 16, 2016
Last Update Posted: April 12, 2017