A Biofeedback Intervention for the Prevention of Challenging Behaviour
Primary Purpose
Acquired Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anxiety management strategy
Sponsored by
About this trial
This is an interventional supportive care trial for Acquired Brain Injury focused on measuring Challenging behaviour, Biofeedback, Anxiety management
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biofeedback intervention
Arm Description
Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
Outcomes
Primary Outcome Measures
Number of incidents of challenging behaviour
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
Secondary Outcome Measures
Implementation of anxiety management strategy
Number of times anxiety management strategy successfully employed
Full Information
NCT ID
NCT03260335
First Posted
August 21, 2017
Last Updated
March 26, 2018
Sponsor
University of Glasgow
Collaborators
Brain Injury Rehabilitation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03260335
Brief Title
A Biofeedback Intervention for the Prevention of Challenging Behaviour
Official Title
A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Favourable ethical opinion not obtained
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Glasgow
Collaborators
Brain Injury Rehabilitation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 heart rate monitor, pedometer and global positioning system (GPS) functions. A pre-calculated algorithm, developed using machine learning software will be used to predict challenging behaviour episodes 2-4 hours in advance of the event. Recent research has developed a best predictor model with a sensitivity of 82% and specificity of 42%, when averaged across two participants (in press). The device will communicate with a smart phone, via Bluetooth connectivity, when an event has been predicted.
Following enrolment in the study, participants will be randomly assigned to a treatment start time, which will follow from an initial baseline phase. During the baseline phase, participants will wear a commercially available smart watch with physiological monitoring capability, for at least one month in order to gather behaviour frequency data, and associated physiological data; no prompts will be provided. During this period, behavioural and physiological data will be sent to a secure server where a machine learning algorithm will examine the relationships between data streams and 'self-tune' to improve its prediction of challenging behaviour episodes. In the treatment phase, participants and staff will receive a biofeedback prompt in text, or graphic form (e.g. mood light), on the smart watch/connected mobile phone, when an event has been predicted. This will prompt participants to implement a proactive anxiety management strategy, and will prompt staff to support the participant in completing this, if required. The strategy used will be predetermined in the participant's standard care plan e.g. breathing relaxation, reframing the problem, behavioural redirection. Details will be recorded using an adapted version of the Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR), describing the situation in which the biofeedback prompt occurred, participant and staff responses to the biofeedback prompt, and any resulting behaviours, including the occurrence of challenging behaviour. Following the intervention phase, participants will return to a baseline phase for one month, in which no prompts will be provided. Again, details of any challenging behaviour will be recorded via the OAS-MNR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Challenging behaviour, Biofeedback, Anxiety management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback intervention
Arm Type
Experimental
Arm Description
Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan
Intervention Type
Behavioral
Intervention Name(s)
Anxiety management strategy
Intervention Description
Anxiety management strategy as per standard care plan
Primary Outcome Measure Information:
Title
Number of incidents of challenging behaviour
Description
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Implementation of anxiety management strategy
Description
Number of times anxiety management strategy successfully employed
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Evans, BSc PhD
Organizational Affiliation
University of Glasgow
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Biofeedback Intervention for the Prevention of Challenging Behaviour
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