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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00127413
First received: August 3, 2005
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

The purpose of this study is to examine the efficacy of an integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder (PTSD). It is hypothesized that Veterans who receive the integrated treatment will report more positive outcomes than individuals who are assigned to treatment as usual, pain treatment, or PTSD treatment.


Condition Intervention
Pain
Posttraumatic Stress Disorder
Behavioral: Cognitive Behavioral Therapy - Pain
Behavioral: Cognitive Behavioral Therapy-Integrated
Behavioral: Cognitive Processing Therapy - PTSD
Behavioral: Treat as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Treatment for Chronic Pain and PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinician Administered Assessment of PTSD [ Time Frame: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up ] [ Designated as safety issue: No ]
    This 30-item structured interview is designed to assess both the 17 symptoms of PTSD and the 8 hypothesized associated features. The scale yields a dichotomous diagnosis of PTSD, and also provides a continuous score of frequency and severity for each symptom. In addition, a behaviorally anchored probe question is provided for each symptom to increase the reliability of administration. The CAPS has excellent sensitivity (.81) and specificity (.95) (Newman, Kaloupek, & Keane, 1996). For the purpose of these analyses we examined the total CAPS score. Total CAPS scores can range from 0 to 136. Higher scores represent poorer outcome with a score of greater than 50 indicating that a person meets criteria for PTSD.


Enrollment: 42
Study Start Date: September 2004
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy - Pain
Cognitive Behavioral Therapy targeting chronic pain
Behavioral: Cognitive Behavioral Therapy - Pain
Pain treatment
Experimental: Cognitive Behavioral Therapy-Integrated
Integrated treatment for comorbid chronic pain and PTSD
Behavioral: Cognitive Behavioral Therapy-Integrated
Integrated treatment
Experimental: Cognitive Processing Therapy - PTSD
Cognitive Processing Therapy for PTSD
Behavioral: Cognitive Processing Therapy - PTSD
Cognitive processing therapy
Treat as Usual
Participants received care for pain and PTSD as usual from their Primary care provider
Behavioral: Treat as Usual
Treatment as usual

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be eligible for participation if they have chronic pain, defined as constant pain of at least six months duration with a neurologic or musculoskeletal etiology. Patients must also meet criteria for PTSD.
  • Stability of pain and anxiety medications will be required for two months prior to study entry and during the active treatment and TAU phase.

Exclusion Criteria:

  • Patients with life threatening or acute physical illness (e.g., cancer).
  • Current alcohol or substance abuse or dependence. Veterans who have a history of alcohol or drug dependence but who have not had problematic use in the last six months will be included in the study.
  • Current psychosis or suicidal ideation.
  • Individuals seeking pain treatment such as surgical interventions will be excluded.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127413

Locations
United States, Massachusetts
VA Boston Health Care System, Jamaica Plain
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: John Otis, BS BA PhD VA Boston Health Care System, Jamaica Plain
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00127413     History of Changes
Other Study ID Numbers: D3322-R
Study First Received: August 3, 2005
Results First Received: November 17, 2014
Last Updated: March 23, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Chronic pain
Co-morbid
Intervention
Posttraumatic Stress Disorder
Treatment

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

ClinicalTrials.gov processed this record on April 30, 2015