Status:
WITHDRAWN
A Biofeedback Intervention for the Prevention of Challenging Behaviour
Lead Sponsor:
University of Glasgow
Collaborating Sponsors:
Brain Injury Rehabilitation Trust
Conditions:
Acquired Brain Injury
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
This study aims to explore whether feedback from a physical monitoring device (electronic watch) to prompt patients to use an anxiety management strategy can help prevent challenging behaviour.
Detailed Description
A multiple baseline "A-B-A" single case experimental design will be adopted with baseline, intervention, and return to baseline phases. Participants will wear the portable monitoring device with hear...
Eligibility Criteria
Inclusion
- participants who have sustained a severe injury to the brain, as determined by length of unconsciousness (greater than 24 hours), a Glasgow Coma Scale of 3 to 8 and a Post Traumatic Amnesia period greater than 1 day
- participants who are resident in the Graham Anderson House, Brain Injury Rehabilitation (BIRT) Unit
- participants presenting with challenging behaviour, during the recruitment period
- participants will NOT be excluded on the basis of comorbid psychiatric disorders or drug/alcohol use, in order to provide conclusions representative of the clinical population
- participants will NOT be excluded on the basis of being unable to provide informed consent, in order to provide conclusions representative of the clinical population
Exclusion
- a level of cognitive impairment that would prevent individuals from understanding the feedback obtained via digital or verbal prompts
- participants without the capacity to consent, that do not provide verbal assent to participate in the study
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03260335
Start Date
November 1 2017
End Date
June 1 2018
Last Update
March 29 2018
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