- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120067
Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives:
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients will be eligible to participate if they have constant pain of at least three months duration with a neurologic or musculoskeletal etiology.
- Patients must also meet diagnostic criteria for PTSD.
Exclusion Criteria:
- Patients with life threatening or acute physical illness, current alcohol or substance abuse, current psychosis or suicidal ideation, and individuals seeking pain treatment such as surgical interventions will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive Treatment
Intensive 3 week treatment for pain and PTSD.
This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
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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.
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Experimental: Treatment as Usual
Treatment as Usual.
Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
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Treatment as Usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: John Otis, BS BA PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D6281-I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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