ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01120067
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : December 16, 2016
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Intensive Treatment Behavioral: Treatment as Usual Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: John Otis, BS BA PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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 Posted: May 10, 2010    Key Record Dates
Results First Posted: December 16, 2016
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Psychology
Pain
Veterans
Stress Disorders, Post-Traumatic

Additional relevant MeSH terms:
Chronic Pain
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trauma and Stressor Related Disorders
Mental Disorders