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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01120067
First received: April 30, 2010
Last updated: March 13, 2017
Last verified: March 2017
April 30, 2010
March 13, 2017
August 1, 2010
August 1, 2015   (Final data collection date for primary outcome measure)
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.
The Clinician Administered Assessment of PTSD (CAPS) [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01120067 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans
This study is investigating the efficacy of an intensive (3 week) integrated treatment for Veterans with both pain and PTSD.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
  • 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.
  • Behavioral: Treatment as Usual
    Treatment as Usual.
  • Experimental: Intensive Treatment
    Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain
    Intervention: Behavioral: Intensive Treatment
  • Experimental: Treatment as Usual
    Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD
    Intervention: Behavioral: Treatment as Usual
Tsai J, Whealin JM, Scott JC, Harpaz-Rotem I, Pietrzak RH. Examining the relation between combat-related concussion, a novel 5-factor model of posttraumatic stress symptoms, and health-related quality of life in Iraq and Afghanistan veterans. J Clin Psychiatry. 2012 Aug;73(8):1110-8. doi: 10.4088/JCP.11m07587. Epub 2012 Jun 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
December 29, 2016
August 1, 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01120067
D6281-I
No
Not Provided
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: John Otis, BS BA PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
VA Office of Research and Development
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP