VA Recruiting for PTSD study

[cato2]

Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
This study is currently recruiting patients.
Verified by Department of Veterans Affairs December 2005
Sponsored by: Department of Veterans Affairs Information provided by: Department of Veterans Affairs ClinicalTrials.gov Identifier: NCT00127413
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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. 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 Posttraumatic Stress Disorder
Pain
Behavior: CBT-Pain (cognitive behavioral treatment for chronic pain)
Behavior: CBT-PTSD (cognitive behavioral treatment for PTSD)
Behavior: TAU (treatment as usual)
Behavior: CBT-PTR (integrated cognitive-behavioral treatment for chronic pain and PTSD)



Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study


Official Title: Integrated Treatment for Chronic Pain and PTSD



Further study details as provided by Department of Veterans Affairs:
Primary Outcomes: Pain - West Haven-Yale Multidimensional Pain Inventory (WHYMPI), McGill Pain Questionnaire (MPQ) (pre, post, 6-months); Distress - Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI) (pre, post, 6-months); Disability - developmental quotient (DQ), WHYMPI (pre, post, 6-months); PTSD - Clinician Administered PTSD Scale (CAPS), PTSD Checklist (PCL) (pre, post, 6-months)
Secondary Outcomes: Anxiety Sensitivity Index (pre, session 4 & 8, post, 6-months); Coping Strategies Questionnaire (pre, session 4 & 8, post, 6-months); Fear and avoidance (pre, session 4 & 8, post, 6-months)
Expected Total Enrollment: 136
Study start: September 2004; Expected completion: September 2008
Last follow-up: March 2008; Data entry closure: April 2008


Chronic pain and post-traumatic stress disorder (PTSD) frequently co-occur and are associated with a significant level of affective distress, physical disability, and treatment resistance. However, no empirical studies have been conducted investigating the efficacy of a treatment tailored specifically for individuals with comorbid chronic pain and PTSD.
The primary objective of this study is to evaluate the efficacy of a cognitive-behavioral therapy (CBT) approach for comorbid chronic pain and PTSD. A secondary objective of this study is to examine potential mechanisms of action that might mediate treatment outcome. It is hypothesized that:


1.a) Participants receiving CBT-PTR (integrated cognitive-behavioral treatment for chronic pain and PTSD) will report significantly greater improvements on measures of pain, affective distress, and physical functioning from pre-treatment to post-treatment than participants in the CBT-PAIN (cognitive behavioral treatment for chronic pain), CBT-PTSD (cognitive behavioral treatment for PTSD), or TAU (treatment as usual) conditions;


1.b) CBT-PAIN, CBT-PTSD, and CBT-PTR will be more effective at promoting improved outcomes than TAU;
2) Participants receiving CBT-PTR will report decreased symptoms of PTSD from pre-treatment to post-treatment when compared to participants in the CBT-PAIN, CBT-PTSD and TAU conditions;
3) Participants receiving CBT-PTR will report greater maintenance of change, and greater improvements on measures of Pain, Affective Distress, Physical Functioning, and PTSD at 6 months following the completion of treatment than participants in the other three conditions;
4) As a secondary/exploratory hypothesis, the researchers will examine potential mechanisms of action in treatment.
It is hypothesized that changes in these potential mechanisms will mediate treatment outcome.


The proposed study is a four-treatment condition (CBT-PAIN, CBT-PTSD, CBT-PTR, and TAU) by three-evaluation period (pre-treatment, post-treatment, and 6-month follow-up) repeated measures factorial design with multiple dependent measures. Participants will be 136 patients with co-morbid chronic pain and PTSD receiving care in the VA Boston Healthcare System. Participants in the CBT-PAIN, CBT-PTSD, and CBT-PTR conditions will complete 11 weekly outpatient therapy sessions. A clinical psychologist with specialized training in providing both PTSD and chronic pain treatment protocols will conduct therapy in an individual format, 90 minutes in duration. Participants assigned to the TAU condition will not receive treatment beyond that provided by their primary care provider and other healthcare providers. The CBT-PAIN condition will follow an adaptation of a manualized treatment protocol used by Kerns and colleagues that emphasizes identifying and modifying maladaptive thoughts and behaviors related to the experience of chronic pain. Participants in the CBT-PTSD condition will receive a manualized treatment protocol developed by Keane and colleagues that includes several empirically supported techniques including cognitive restructuring, exposure therapy, and skills training. Participants in the CBT-PTR condition will receive an integrated treatment for comorbid pain and PTSD including components of the pain and PTSD treatments described above.


The proposed study will address the specific objectives of the National Pain Management Strategy by helping to assure that clinicians practicing in the VA healthcare system are adequately prepared to assess and manage chronic pain effectively, especially when comorbid with PTSD. Knowledge gained from the proposed study could potentially be utilized by psychologists and other healthcare providers across the VA system nationwide who are currently engaged in CBT treatment programs for chronic pain and PTSD. Given that CBT has been shown to be efficacious for pain and PTSD, but not for comorbid pain and PTSD, it is imperative that a new integrated treatment be evaluated that has the potential to address the unmet needs of this large population. Thus, this study will have important implications for the delivery of pain management services to veterans and others with chronic pain and PTSD.

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Eligibility
Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

• Patients will be eligible for participation if they have chronic pain, defined as constant pain of at least six months duration (International Association for the Study of Pain [IASP], 1994), with a neurologic or musculoskeletal etiology. Patients must also meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] diagnostic criteria for PTSD (American Psychiatric Association [APA], 1994).
• Stability of pain and anxiety medications will be required for two months prior to study entry and during the active treatment/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.

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Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00127413

John D Otis, Ph.D. 617-232-9500 Ext. 45740 joh.otis@va.gov
Terence Keane 617-232-9500 Ext. 44551 terry.keane@med.va.gov


Massachusetts
VA Boston Healthcare System, Boston, Massachusetts, 02467, United States; Recruiting Liza Catucci 617-232-9500 Liza.Catucci@med.va.gov
John D Otis, Ph.D., Principal Investigator



Study chairs or principal investigators

John D Otis, Ph.D., Principal Investigator, VA Boston Healthcare System
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More Information
The National Center for Post-Traumatic Stress Disorder (PTSD) was created within the Department of Veterans Affairs in 1989, in response to a Congressional mandate to address the needs of veterans with military-related PTSD.
To advance the discovery of new knowledge that optimizes rehabilitation healthcare for veterans
Publications
Otis JD, Keane TM, Kerns RD. An examination of the relationship between chronic pain and post-traumatic stress disorder. J Rehabil Res Dev. 2003 Sep-Oct;40(5):397-405.
Study ID Numbers: D3322R
Last Updated: December 2, 2005
Record first received: August 3, 2005
ClinicalTrials.gov Identifier: NCT00127413
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2007-01-18