Clinical trial NCT02661724: Take Charge of Burn Pain
Official title: Take Charge of Burn Pain: A Randomized Controlled Trial of a Web-based Self-Management Intervention to Improve Burn Pain Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Related Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Phoenix Society for Burn Suvivors
First posted: 2016-01-22
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Severity and Pain-Related Interference
timeFrame: 2 and 5 month
Secondary outcomes:
measure: Change in Depression
timeFrame: 2 and 5 month
measure: Change in Participation in life activities
timeFrame: 2 and 5 month
measure: Change in PTSD Anxiety
timeFrame: 2 and 5 month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Stephen Wegener, PhD
role: PRINCIPAL_INVESTIGATOR
References: