Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT01120067|
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : December 16, 2016
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Intensive Treatment Behavioral: Treatment as Usual||Not Applicable|
The primary objective of this study is to evaluate the efficacy of an intensive integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). A secondary objective is to examine potential mechanisms of action that might account for improvements in pain or PTSD. Third, exploratory analyses will be conducted to assess the relationship between participation in treatment and cognitive functioning. It is hypothesized that 1) participants receiving the intensive treatment (PT) will report significantly greater decreases in symptoms of pain and PTSD from pre-treatment to post-treatment when compared to participants randomized to a standard care (SC) condition, and 2) participants receiving PT will show greater maintenance of change on measures of pain and PTSD at 3 months following the completion of treatment when compared to participants randomized to the SC condition.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans|
|Actual Study Start Date :||August 1, 2010|
|Actual Primary Completion Date :||August 1, 2015|
|Actual Study Completion Date :||December 29, 2016|
Experimental: Intensive Treatment
Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
Behavioral: 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.
Experimental: Treatment as Usual
Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
Behavioral: Treatment as Usual
Treatment as Usual.
- McGill Pain Questionnaire [ Time Frame: 6 months ]McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120067
|United States, Connecticut|
|VA Connecticut Healthcare System West Haven Campus, West Haven, CT|
|West Haven, Connecticut, United States, 06516|
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||John Otis, BS BA PhD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|