Take Charge of Burn Pain

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.

Inclusion Criteria:

1. Persons ages 18 to 70 years old having experienced a burn injury requiring
hospitalization at least 6 months prior to enrollment;

2. Reporting a pain severity score on the Brief Pain inventory of 4 (0-10) or higher;

3. Reporting pain of at least 3 months duration; and

4. English speaking due to feasibility of providing the web-based intervention only in
English at this time.

Exclusion Criteria:

1. Significant neurological or psychiatric condition precluding informed consent.

2. Lack of access to a computer that is connected to the worldwide web.