This trial is active, not recruiting.

Condition stress disorders, post-traumatic
Treatment intensive treatment
Sponsor VA Office of Research and Development
Start date August 2010
End date August 2015
Trial size 102 participants
Trial identifier NCT01120067, D6281-I


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Intensive 3 week treatment for pain and PTSD
intensive treatment
Participants randomized to the PT condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.
(No Intervention)
treatment as usual

Primary Outcomes

The Clinician Administered Assessment of PTSD (CAPS)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans
Principal investigator John Otis, BS BA PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.