Treatment of Post-Traumatic Stress Disorder (PTSD) and Chronic Pain After Traumatic Orthopedic Injury
Condition: Chronic Pain; Post-traumatic Stress Disorder
MeSH terms: Chronic Pain; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of multiple treatment options in
      addressing the co-morbidity between pain and PTSD symptoms. Recent research has suggested
      that pain and PTSD co-morbidity presents unique problems for pain and PTSD treatment, and new
      approaches are desperately needed to address this issue. To this end, the investigators hope
      to identify the efficacy of a combined pain and PTSD psychosocial treatment protocol compared
      to that of stand-alone psychosocial treatments for pain and PTSD. The primary measure for
      treatment efficacy will be treatment-related changes in measures of psychosocial and
      functional outcomes associated with chronic pain and PTSD conditions. The investigators will
      additionally measure socioeconomic outcomes including return to pre-trauma job (or a job of
      similar capacity), maintenance of active duty work at pre-trauma capacity for 6 and/or 12
      months after return, and number of healthcare appointments made between follow-ups for pain
      or PTSD treatment.
    

Detailed description: 
      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.
    

Intervention name(s): Brief Prolonged Exposure Protocol; Chronic Pain Management Treatment; Self-Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The PTSD treatment used in this study is an adaptation of a brief Prolonged Exposure treatment protocol for PTSD as illustrated in a 2005 paper published by Cigrang, Peterson, and Schobitz 54 in which a 4-session prolonged exposure treatment was used to address PTSD symptoms in three injured soldiers recently exposed to trauma. The authors found a 50+% decrease in PTSD symptoms after these four sessions. The present study will rely upon a similar brief PTSD intervention for treating chronic PTSD among trauma-exposed injured active duty service members. The PTSD intervention will be expanded into five sessions over 5 weeks to include an initial session for assessment and education on the co-morbidity of pain and PTSD. All PTSD treatment will be provided under the direct care or supervision of a Master Trained therapist in Prolonged Exposure.; Pain treatment will involve five-sessions over 5 weeks of individual treatment protocol based on the existing chronic pain management program through the Clinical Health Psychology Service at Wilford Hall Medical Center. This treatment will involve covering the difference between chronic and acute pain, the role of cognitive, behavioral, and emotional variables in pain progression, and ways to manage these variables to prevent the development of chronic pain.; participants randomized to either the Pain-only or PTSD-only groups will receive five sessions of pain- or PTSD-specific treatment followed by five sessions of self-care placebo over 5 weeks. The self-care module will be manualized for reliability and fidelity between providers and will involve 60-minute sessions covering various topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic pain; PTSD