Treatment of Post-Traumatic Stress Disorder (PTSD) and Chronic Pain After Traumatic Orthopedic Injury

This study will use a four-group randomized experimental design similar to that used in a
study currently being conducted by John Otis with VA patients with chronic pain/chronic
PTSD. The four groups will include Pain Treatment (PAIN) only, PTSD Treatment (PTSD) only,
Pain and PTSD Treatments (PAIN+PTSD), and treatment as usual (TAU). The investigators
hypothesize that treating individuals with chronic pain and PTSD (e.g., more than 6 months
in duration) symptoms through a proven psychosocial model will help to improve
psychological, socioeconomic and physical symptoms of these chronic clinical syndromes that
have been shown to be unfortunately recalcitrant to treatment and enormously costly both to
society healthcare and, more importantly, to the person suffering from enduring pain and
traumatic stress. We further hope to demonstrate the efficacy of these early treatments in
facilitating the return to active duty of military personnel suffering from pain and
traumatic stress. Finally, we hope to positively impact other psychosocial and
socioeconomic outcomes such as work retention (as measured by self-report work status and
retention of work at 6- and 12-month follow-up), additional health-care utilization (as
measured by self-report of number of PTSD or pain-related healthcare visits), depression
symptoms (as measured by the Beck Depression Inventory), health-related quality of life (as
measured by the SF-36), and perceived disability (as measured by the Million Visual Analog
Scale). Evaluations of these four groups will be conducted at pre-treatment, immediately at
the post-treatment, and at 6- and 12-month follow-up periods in order to determine
differential outcomes on variables such as PTSD and pain symptom presence/severity,
self-reported pain and disability, functional gains, satisfaction with treatment, return to
active duty, retention of pre-trauma work capacity at 6- and 12-month follow-up, and
additional health-care utilization as measured by number of healthcare appointments attended
for pain or PTSD symptom management. The initial post-treatment evaluation will occur at the
end of the ten-week treatment interval for each individual's randomization block. For those
in the treatment as usual (TAU) group, post-treatment assessment will occur ten weeks after
pre-treatment assessment is completed. Changes in functional activity status, psychosocial
functioning, and satisfaction with treatment will also be systematically evaluated before,
immediately after, and during the post-treatment periods. It should be noted that many of
the PAIN-only, and TAU subjects may receive some type of standard care for PTSD symptoms if
they access those services on their own. The same could be true for the PTSD-only and TAU
subjects. They may also receive some type of standard care for pain symptoms that they
access on their own. The investigators will monitor any such services received in order to
attempt to control for possible spurious effects of outside treatment in later analyses.

Inclusion Criteria:

- age 18 years or older

- hospital admission for any traumatic orthopedic injury defined as any
musculo-skeletal injury requiring convalescence and/or surgery that is deployment
related.

- Fluency in English

- Glasgow Coma Score (GCS) = 15 at time of hospital discharge

- willingness and ability to meet study follow-up requirements

- PTSD CheckList - Military (PCL-M) > 30

- duration of any amount of pain >12 weeks based on self-report and date of injury, and
PTSD symptoms of > to 4 weeks.

- Pain Disability Questionnaire (PDQ) > 30

- no current need for surgical intervention for pain

- be stable on any psychotropic medications they may be taking. (Participants will be
required to meet psychotropic medication stabilization criteria for the periods
preceding and overlapping with the diagnostic assessment and treatment. This
criterion is established in order to minimize the likelihood that significant outcome
effects may be attributed to changes in psychotropic medications rather than to the
treatment protocol.)

- medically cleared for study participation by Orthopedic provider or collaborating
study physician

- Active Duty Military, Reserve, or Activated Reservist

Exclusion Criteria:

- head injury greater than mild TBI as assessed by an inability to consent to the study
and complete the baseline psychological testing

- current pregnancy will exclude participation in Functional Capacity Evaluation (FCE)
assessment, but not study participation. Pregnancy will be assessed by self-report

- current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder as
identified by clinical interview

- primary diagnosis of burn injury, though burn patients will be eligible if burn is a
secondary diagnosis and not the primary reason for pain

- participant is currently taking a benzodiazepine medication for PTSD symptoms

- unstable suicidal ideation

- currently receiving prolonged exposure treatment for PTSD