Integrated Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
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. 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.
Description
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pain
Intervention
CBT-Pain (cognitive behavioral treatment for chronic pain), CBT-PTR (integrated cognitive-behavioral treatment for chronic pain and PTSD), CBT-PTSD (cognitive behavioral treatment for PTSD), TAU (treatment as usual)
Location
VA Boston Health Care System, Jamaica Plain
Boston
Massachusetts
United States
02130
Status
Recruiting
Source
Department of Veterans Affairs
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00127413
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Catastrophization
Cognitive and emotional processes encompassing magnification of pain-related stimuli, feelings of helplessness, and a generally pessimistic orientation.
Cognitive Therapy
A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.
Delirium, Dementia, Amnestic, Cognitive Disorders
Cognitive disorders including delirium, dementia, and other cognitive disorders. These may be the result of substance use, trauma, or other causes.
Pain, Referred
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
Facial Pain
Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.
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PubMed Articles
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