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Take Charge of Burn Pain

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ClinicalTrials.gov Identifier: NCT02661724
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
The Phoenix Society for Burn Suvivors
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Burn Related Pain Behavioral: TCBR-Pain Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Take Charge of Burn Pain: A Randomized Controlled Trial of a Web-based Self-Management Intervention to Improve Burn Pain Outcomes
Study Start Date : April 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Take Charge Burn - Pain (TCBR-Pain)
The TCBR-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.
Behavioral: TCBR-Pain
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.

No Intervention: Education attention control
The attention group receives an educational materials that is matched to the TCBR-Pain intervention in terms of session length and time on the web-based program. The web-based Education attention condition includes 7 sessions delivered over 7 weeks. The Education Attention Control is education materials commonly employed in rehabilitation centers and has been successfully used in several studies as a comparison to active rehabilitation interventions



Primary Outcome Measures :
  1. Change in Pain Severity and Pain-Related Interference [ Time Frame: 2 and 5 month ]
    The Brief Pain Inventory (BPI) will be used to assess pain severity and establish that the pain intensity inclusion criteria are met. The BPI includes two primary dimensions: pain severity (4 items) and pain interference (7 items), each rated on 0 to 10 scales.


Secondary Outcome Measures :
  1. Change in Depression [ Time Frame: 2 and 5 month ]
    Depression and PTSD Anxiety will be measured using the Patient Health Questionnaire-9 (PHQ-9) . In a psychometric study of the PHQ-9, the instrument demonstrated acceptable test-retest reliability and was both sensitive (0.93) and specific (0.89) when compared to a diagnosis of major depression in persons with traumatic injury.

  2. Change in Participation in life activities [ Time Frame: 2 and 5 month ]
    Participation in life activities will be measured using the World Health Organization Disability Assessment Scales (WHODAS-II) is a 36-item general disability instrument that has been specifically designed to use the ICIDH-2 framework to evaluate the dimensions of disability- activity and participation.

  3. Change in PTSD Anxiety [ Time Frame: 2 and 5 month ]
    PTSD Checklist-Civilian Version (PCL-C). The PCL-C has demonstrated acceptable test-retest reliability and internal consistency values and good convergent validity with moderate to high correlations with other PTSD instruments and measures of anxiety and depression in persons with traumatic injury. Studies have also found that trauma survivors with PCL-C scores ≥ 45 have a greater than 75% probability of developing symptoms consistent with a diagnosis of PTSD.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661724


Contacts
Contact: Stephen Wegener, PhD 410-502-2441 swegener@jhmi.edu
Contact: Patiricia Kirkhart, Ba 410-502-4453 pkirkha1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Patricia R Kirkhart, BA    410-502-4453    pkirkha1@jhmi.edu   
Principal Investigator: Stephen T Wegener, PhD         
Sponsors and Collaborators
Johns Hopkins University
The Phoenix Society for Burn Suvivors
Investigators
Principal Investigator: Stephen Wegener, PhD Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02661724     History of Changes
Other Study ID Numbers: IRB00054201
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Burns
Wounds and Injuries