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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01120067
First received: April 30, 2010
Last updated: August 5, 2014
Last verified: August 2014

April 30, 2010
August 5, 2014
August 2010
August 2015   (final data collection date for primary outcome measure)
The Clinician Administered Assessment of PTSD (CAPS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The Clinician Administered Assessment of PTSD (CAPS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
Behavioral: 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.
  • Experimental: Arm 1
    Intensive 3 week treatment for pain and PTSD
    Intervention: Behavioral: Intensive Treatment
  • No Intervention: Arm 2
    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.
 
Recruiting
102
September 2015
August 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.
Both
18 Years and older
No
Contact: John Otis, BS BA PhD (857) 364-5740 john.otis@va.gov
Contact: Ilan Harpaz-Rotem, PhD (203) 937-4760 ext 2599/4760 ilan.harpaz-rotem@va.gov
United States
 
NCT01120067
D6281-I
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: John Otis, BS BA PhD VA Boston Health Care System, Jamaica Plain
Department of Veterans Affairs
August 2014

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