A Biofeedback Intervention for the Prevention of Challenging Behaviour

NCT03260335 | Withdrawn

• 1 other identifier: 17/SS/0119
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acquired Brain Injury

Keywords

Challenging behaviour; Biofeedback; Anxiety management

Outcome Measures

Primary Outcomes (1)

• Number of incidents of challenging behaviour

  Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)

  5 months

Secondary Outcomes (1)

• Implementation of anxiety management strategy

  5 months

Study Arms (1)

Biofeedback intervention

EXPERIMENTAL

Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan

Behavioral: Anxiety management strategy

Interventions

Anxiety management strategy BEHAVIORAL

Anxiety management strategy as per standard care plan

Biofeedback intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• Brain Injury Rehabilitation Trust: collaborator

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jonathan Evans, BSc PhD

  University of Glasgow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Applied Neuropsychology

Model Details: Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 24, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03