A Biofeedback Intervention for the Prevention of Challenging Behaviour

A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury

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.

Study Overview

• Status: Withdrawn
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Behavioral: Anxiety management strategy

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofeedback intervention; Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan	Behavioral: Anxiety management strategy; Anxiety management strategy as per standard care plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of incidents of challenging behaviour	Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of anxiety management strategy	Number of times anxiety management strategy successfully employed	5 months

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: Brain Injury Rehabilitation Trust
• Investigators: Study Director: Jonathan Evans, BSc PhD, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Biofeedback; Anxiety management; Challenging behaviour
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 17/SS/0119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No