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

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ClinicalTrials.gov Identifier: NCT00127413
Recruitment Status : Completed
First Posted : August 5, 2005
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Posttraumatic Stress Disorder Behavioral: Cognitive Behavioral Therapy - Pain Behavioral: Cognitive Behavioral Therapy-Integrated Behavioral: Cognitive Processing Therapy - PTSD Behavioral: Treat as Usual Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Treatment for Chronic Pain and PTSD
Study Start Date : September 2004
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Clinician Administered Assessment of PTSD [ Time Frame: Pretreatment (baseline), Posttreatment (3 months), and 6 month Follow-up ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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): NCT00127413


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

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00127413     History of Changes
Other Study ID Numbers: D3322-R
First Posted: August 5, 2005    Key Record Dates
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by VA Office of Research and Development:
Chronic pain
Co-morbid
Intervention
Posttraumatic Stress Disorder
Treatment

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