Acquired Brain InjuryNCT03260335
A Biofeedback Intervention for the Prevention of Challenging Behaviour
A study testing Anxiety management strategy in people with Acquired Brain Injury, run by University of Glasgow.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Anxiety management strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Acquired Brain Injury
- Being tested
- Anxiety management strategy
- Keywords
- Challenging behaviour, Biofeedback, Anxiety management
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety management strategyBehavioural
Anxiety management strategy as per standard care plan
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback intervention | Experimental | Biofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan Receives: Behavioral: Anxiety management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of incidents of challenging behaviour
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
Measured: 5 months
Secondary outcomes (1)
Implementation of anxiety management strategy
Number of times anxiety management strategy successfully employed
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startNov 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: Favourable ethical opinion not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Responsible party
- Principal investigator, Professor Jon Evans, University of Glasgow
- Investigators
- Jonathan Evans, BSc PhD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260335
- Sponsor's protocol ID
- 17/SS/0119
- Status last verified
- Mar 2018
- First submitted
- 21 Aug 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biofeedback Intervention for the Prevention of Challenging Behaviour in People With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03260335
- Acronym / sponsor ID
- 17/SS/0119
- Conditions
- Acquired Brain Injury
- Keywords
- Challenging behaviour, Biofeedback, Anxiety management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Favourable ethical opinion not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Brain Injury Rehabilitation Trust
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design combining withdrawal (ABA) and multiple baseline design,
| Arm | Type | Receives |
|---|---|---|
| Biofeedback intervention | Experimental | Behavioral: Anxiety management strategyBiofeedback prompt in text or graphic form to implement proactive anxiety management strategy, as per standard care plan |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety management strategyAnxiety management strategy as per standard care plan | Behavioural | Biofeedback intervention |
Primary outcome
Number of incidents of challenging behaviour
Time frame: 5 months
Score from Overt Aggression Scale-Modified for Neurorehabilitation (OAS-MNR)
1 secondary outcome
Implementation of anxiety management strategy
Time frame: 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Evans, BSc PhD study director
University of Glasgow
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety management strategy in people with Acquired Brain Injury, run by University of Glasgow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of incidents of challenging behaviour (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.