Text Size

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

This study is currently recruiting participants.
Verified February 2013 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: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Stress Disorders, Post-Traumatic
 Behavioral: Intensive Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Treatment of Chronic Pain and PTSD for OEF/OIF Veterans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Clinician Administered Assessment of PTSD (CAPS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Intensive 3 week treatment for pain and PTSD
 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.
No Intervention: Arm 2
treatment as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120067

Contacts
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

Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Ilan H Rotem, PhD     203-737-4434     ilan.harpaz-rotem@va.gov    
United States, Massachusetts
VA Boston Health Care System, Jamaica Plain Recruiting
Boston, Massachusetts, United States, 02130
Contact: Maria Higgins     857-364-4802     maria.higgins@va.gov    
Principal Investigator: John Otis, BS BA PhD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: John Otis, BS BA PhD VA Boston Health Care System, Jamaica Plain
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01120067     History of Changes
Other Study ID Numbers: D6281-I
Study First Received: April 30, 2010
Last Updated: February 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Psychology
Pain
Veterans
Stress Disorders, Post-Traumatic

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013