| Study summary: |
|
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. |
| 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. |