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

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic

• Registration Number: NCT01120067
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.

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 Timeline

• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Study Start: 2010-08-01
• Primary Completion: 2015-08-01
• Results First Submitted: 2016-10-24
• Results First Submitted QC: 2016-10-24
• Results First Posted: 2016-12-16
• Study Completion: 2016-12-29
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
McGill Pain Questionnaire	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.

Trial Locations

Locations (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States