Take Charge of Burn Pain
Condition: Burn Related Pain
MeSH terms: Burns
Study type: Interventional

Summary: 
      Persons with burn-related pain remain under treated and do not have access to comprehensive
      burn pain management. We seek to extend evidence-based cognitive behavioral pain management
      strategies to a group of burn survivors that are currently under treated for for burn pain
      with a specific goal of reducing pain related interference in life activities.

      Investigators will conduct a randomized controlled trial to test the central hypothesis that
      a computer-based cognitive-behavioral program (Take Charge of Burn Pain) will improve pain
      management, psychological health, and improve participation in burn survivors. Specific aims
      include: 1) to determine the efficacy of a web-based self-management intervention in reducing
      pain and pain-related interference and increasing pain management self-efficacy; and 2) to
      determine whether Take Charge of Burn Pain improves psychological health and participation in
      life activities in persons with burn injury pain. Emerging research suggests that web-based
      pain management interventions may be a feasible and effective alternative to clinic-based
      interventions for patients with mobility and geographic restrictions, such as those treated
      at tertiary burn centers.
    

Detailed description: 
      Burns are among the most painful of all injuries requiring painful daily wound care and
      rehabilitation procedures. Despite the best efforts of burn care professionals, burns
      frequently result in acute and chronic suffering and poor functional outcomes for otherwise
      healthy individuals with many years of productive life remaining. The evidence base directing
      burn pain management is generally weak, with much work based on clinical preferences rather
      than scientific evidence. There is a tremendous need for clinical trials to evaluate and
      improve the standard of care. While pharmacological treatment options are widely available
      for burn survivors throughout the emergent, acute, and rehabilitation phases of healing there
      is limited access to comprehensive pain management. It is critical to establish accessible
      pain management approaches that address the emotional, cognitive and physical dimensions of
      the burn pain experience. Cognitive behavioral therapy (CBT) has proven effective for
      patients with chronic pain and studies have demonstrated the efficacy of providing
      tele-rehabilitation CBT services for improving outcomes in persons with disability. However,
      tele-rehabilitation CBT pain management has not been traditionally offered or studied in
      persons with burn-related pain. The population of burn survivors has limited access to
      comprehensive pain management including CBT due to lack of access, financial constraints, and
      mobility issues that render clinic-based CBT impractical. Innovative rehabilitation
      interventions and delivery methods are needed to improve pain, functional, psychological and
      participation outcomes in burn survivors with significant, yet untreated, pain problems.

      Investigators propose to conduct a two group randomized controlled trial to test the central
      hypothesis that web-based CBT will improve pain severity, pain interference, self-efficacy,
      psychological health and participation in life activities for burn survivors with pain.
      Emerging research suggests that tele-rehabilitation may be a feasible, and effective
      alternative (with much broader applicability) to clinic-based interventions for patients with
      access restrictions. This project will address 2 specific aims:

      Specific Aim 1: To determine the efficacy of a web-based, CBT self-management intervention
      (Take Charge of Burn Recovery - Pain [TCBR-Pain) in improving pain management self-efficacy,
      and reducing pain and pain-related interference in burn survivors with pain.

      Outcomes will be measured using a battery of standardized tests at baseline, 2 month
      (treatment completion) and 5 month post-treatment follow-up. Self-reported pain
      self-efficacy, pain severity and pain interference will be measured using validated
      instruments (Pain Self-efficacy Scale, Brief Pain Inventory respectively).

      Hypothesis 1: TCBR- Pain participants will demonstrate significantly greater improvement in
      pain self-efficacy, pain severity and pain interference relative to the attention-control
      group at 2 month (treatment completion) and 5 month follow up.

      Specific Aim 2: To determine the efficacy of a web-based, CBT self-management intervention
      ((Take Charge of Burn Recovery - Pain [TCBR - Pain]) for improving psychological health and
      participation in life activities for burn survivors with pain.

      Outcomes will be measured using a battery of standardized tests at baseline, 2 month
      (treatment completion) and 5 month follow-up. Self-reported depression and anxiety, and
      participation in life activities will be measured using validated instruments (PHQ-9
      Depression Scale and PCL -Civilian Anxiety Scale, and the World Health Organization
      Disability Assessment Scales [WHODAS-II]) respectively.

      Hypothesis 2: TCBR- Pain participants will demonstrate significantly greater improvement in
      depressive and anxiety symptoms and participation relative to the attention-control group at
      2 month (treatment completion) and 5 month follow up.

      This initial randomized trial will provide critical data on recruitment and retention as well
      as effect sizes and sample sizes for in the next stage of research - a multi-center, clinical
      trial which will determine scalability of the intervention. In the proposed study, we will
      consent 256 burn survivors with pain and randomly assign them to the intervention or control
      group. After informed oral consent is obtained, potential participants will be screened for
      eligibility. If eligible, (see inclusion/exclusion criteria below) participants will be
      consented and will complete the baseline assessment on-line. Once the web-based assessment is
      complete, the participants will be randomly assigned to either the web-based 7 lesson TCBR -
      Pain program or the 7 lesson Attention Control -Education group. Randomization will occur in
      balanced blocks to stratify group composition by pain level, self-reported Total Burn Surface
      Area, and time since initial burn injury. Participants will complete the post-intervention
      assessment at 2 months and again at 5 months to assess pain severity, pain interference,
      psychological health, and participation in life activities. Participants who obtain other
      treatments while enrolled in the study will be included and these other interventions will be
      documented and controlled in analyses if necessary. Findings from this study will support
      future research and dissemination efforts to improve the pain management, psychological
      health and life participation of patients following burn injury through innovative
      rehabilitation interventions and delivery methods.
    

Intervention name(s): TCBR-Pain
Intervention type(s): Behavioral
Intervention description(s): The interactive TCBR-Pain uses programmed learning, skill development and behavioral practice to engage persons with burn pain in self-management of pain and related problems. The TCB-Pain program includes 7 lessons addressing key dimensions of pain management for persons with burn injury. Each session is about 20 minutes and focuses on burn injury recovery and life style education. Sessions begin with a brief self-assessment and in later sessions, the participant is given graphical feedback on their progress. The lessons are narrated and include closed captioning, are animated, and include branching to provide personalized content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment