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Trial registered on ANZCTR


Registration number
ACTRN12618002031246
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
19/12/2018
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of biofeedback training to regulate emotions following traumatic brain injury
Scientific title
Heart rate variability biofeedback training as remediation technique for emotion regulation difficulties following a traumatic brain injury: a randomised waitlist-control trial
Secondary ID [1] 296869 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 310784 0
emotion regulation 310785 0
emotional well-being 310786 0
psychological distress 310787 0
sleep disturbances 310788 0
Condition category
Condition code
Neurological 309463 309463 0 0
Other neurological disorders
Mental Health 309498 309498 0 0
Depression
Mental Health 309499 309499 0 0
Anxiety
Injuries and Accidents 309500 309500 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial examines whether heart rate variability biofeedback training can be used to regulate emotional difficulties for individuals with traumatic brain injury. Biofeedback training involves training individuals to breathe at a reduced rate so they can gain control over the physiological processes contributing to the heart and to increased their heart rate variability. To do this, participants will complete six treatment sessions with a research clinician (6 x one-hour sessions over a 2 week period, i.e., 3 treatments per week with at least one day rest between sessions). They will be connected to physiological equipment that measures their heart rate, breathing rate, and skin conductance levels. Treatment sessions involve training participants to breathe at their resonant frequency. This is done in time with a visual pacer displayed on a computer screen and when they are breathing at their resonant frequency, a light on the computer screen will illuminate to provide positive reinforcement and feedback. Each block lasts for 10 minutes and is competed 4 times throughout each session. There is a break between each block, with the length determined by the participant as to when they are ready to commence the new block. Participants are then given homework in-between sessions whereby they are to practice breathing at their resonant frequency at a pace advised to them by the treating researcher. To do this, they can use a phone app, a website or a second hand on a watch. They are asked to do this twice a day for 20 minutes a day. They are provided with a homework worksheet that they need to complete in order to determine their homework fidelity and brought with them during each session to be checked over by the research clinician. The clinicians also fill out treatment forms in order to determine treatment fidelity and adherence to the intervention. The entire intervention lasts for two weeks.
Intervention code [1] 313144 0
Treatment: Other
Intervention code [2] 313145 0
Behaviour
Intervention code [3] 313146 0
Rehabilitation
Comparator / control treatment
The control group consists of a waitlist-control group whereby participants allocated to this condition will receive the treatment but at a later date compared to those in the active condition. The waitlist group will be offered the intervention after they complete the post-assessment, typically after a minimum of 2 weeks from the pre-assessment.
Control group
Active

Outcomes
Primary outcome [1] 308427 0
Changes to heart rate variability (as measured by frequency based analyses consistent with the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology, 1996) is in reaction to an anger induction procedure (negative videos and a challenging cognitive task)
Timepoint [1] 308427 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Primary outcome [2] 308462 0
Changes to skin conductance (as measured by electrodermal activity of the 2nd and 3rd digits) in reaction to the anger induction procedure (negative videos and a challenging cognitive task)
Timepoint [2] 308462 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Primary outcome [3] 308463 0
Changes to the subjective mood (as measured by profile of mood states questionnaire and self-report maniken) in reaction to the anger induction procedure (negative videos and a challenging cognitive task)
Timepoint [3] 308463 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Secondary outcome [1] 354933 0
General emotional well-being as indexed by self-report on the profile of mood-states and self-report manikin at the beginning of the pre and post assessments
Timepoint [1] 354933 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Secondary outcome [2] 354934 0
Symptoms of psychological distress as indexed by self-report of symptoms of depression, stress, and anxiety (as measured by the Depression, Anxiety and Stress Scale and the Hospital Anxiety and Depression Scale).
Timepoint [2] 354934 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Secondary outcome [3] 354935 0
Changes to physiology (as measured by heart rate variability using frequency based analyses consistent with the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology, 1996) during a 5 minute recording at rest at the beginning of the pre and post assessments. This is distinct from our primary outcome as this is at rest while our primary outcome is changes to HRV in response to an anger provocation task.
Timepoint [3] 354935 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Secondary outcome [4] 354936 0
Symptoms of sleep disturbances as indexed by the Pittsburgh Sleep Quality Index
Timepoint [4] 354936 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Secondary outcome [5] 355005 0
Changes to exercise as measured by the International Physical Activity Questionnaire
Timepoint [5] 355005 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.
Secondary outcome [6] 355006 0
Changes to physiology (as measured by skin conductance as measured by electrodermal activity of the 2nd and 3rd digits)) during a 5 minute recording at rest at the beginning of the pre and post assessments. This is distinct from our primary outcome as this is at rest while our primary outcome is changes to skin conductance in response to an anger provocation task.
Timepoint [6] 355006 0
A pre intervention assessment will be done at time of enrolment and a post-assessment will be completed after completion of intervention at 2 weeks.

Eligibility
Key inclusion criteria
- Individuals with who have sustained a traumatic brain injury of at least moderate severity (as indexed by a post traumatic amnesia greater than 24 hours or other brain injury markers of changes to brain CT)
- Aged 16 years or over at the time of injury
- At least 12 months post injury
- Able to provide informed consent
- Fluent in conversational English to complete assessment
Minimum age
17 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any history of pre-existing neurological disorder (i.e., stroke, meningitis, or tumour)
- Less than 12 months post injury
- Sustained their injury during childhood or adolescence (< 16 years)
- Those who sustained concussions or brain injuries of mild severity (PTA < 24 hours)
- Non English speaking or communication issues (i.e., dysphagia or aphasia)
- Current treatment with psycho-active medications
- Any history of heart problems or abnormal ECG

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a coin toss
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
There are both active and waitlist-control groups. Those in the waitlist-control will receive the biofeedback treatment after a delay.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Post-intervention results will be analysed between active and waitlist-control groups across primary and secondary outcomes, controlling for baseline performance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2016
Date of last participant enrolment
Anticipated
Actual
12/11/2018
Date of last data collection
Anticipated
Actual
26/11/2018
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25143 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 301438 0
Government body
Name [1] 301438 0
National Health Medical and Research Council
Country [1] 301438 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Mathews Building, School of Psychology, University of New South Wales, Kensington, NSW 2052
Country
Australia
Secondary sponsor category [1] 301127 0
None
Name [1] 301127 0
Address [1] 301127 0
Country [1] 301127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302172 0
Royal Prince Alfred Research Ethics and Governance Office
Ethics committee address [1] 302172 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
50 Missenden Rd
Camperdown NSW 2050
Ethics committee country [1] 302172 0
Australia
Date submitted for ethics approval [1] 302172 0
Approval date [1] 302172 0
14/04/2015
Ethics approval number [1] 302172 0

Summary
Brief summary
This research study examines new approaches to help people regulate their emotions after brain injury. The objective is to determine whether a technique of biofeedback is useful to assist in emotion regulation. The study is being conducted at the University of New South Wales by Professor Skye McDonald, UNSW, and researchers in her team who work under her supervision.

In order to better understand how we can improve emotion regulation difficulties experienced by people with brain injuries, we need to include individuals who have had brain injury in our research. Participants will be asked to attend up to 9 sessions over 2-3 weeks, each of which will take approximately 1-2 hours. Most sessions will take place at the University of New South Wales’ Kensington campus.

The first and the last session will assess naturally-occurring changes to heart rate while breathing at different rates. To do this, a flexible belt will be fitted around the waist (to measure respiration) and small electrodes will be placed on the undersides of the wrists and fingers (to measure heart rate and skin conductance).

During recording, participants will be asked to perform some computer tasks (such as counting numbers) and watch some short video clips. After the first session, participants will be told whether they have been allocated to immediate treatment or deferred treatment.

Immediate biofeedback treatment: Participants will attend six sessions which will also involve monitoring heart rate and breathing. In these sessions participants will be asked to follow instructions on a screen concerning this.

Deferred treatment: Participants will be asked to wait two weeks before treatment commences. They will attend a second “assessment” session before commencing.

We will ask participants to complete some questionnaires and we may ask a close relative also. We will access information from hospital files to complete our records.

The protocol has been approved by the Research Ethics and Governance Office at Royal Prince Alfred Hospital: PROTOCOL X16-0279 & HREC/08/RPAH141 – "Emotion disorders following traumatic brain injury: An experimental approach to remediation"
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89370 0
Prof Skye McDonald
Address 89370 0
1010 Mathews Building
School of Psychology
University of New South Wales
Kensington
NSW, 2052
Country 89370 0
Australia
Phone 89370 0
+61 2 9385 3029
Fax 89370 0
Email 89370 0
[email protected]
Contact person for public queries
Name 89371 0
Travis Wearne
Address 89371 0
1309 Mathews Building
School of Psychology
University of New South Wales
Kensington
NSW, 2052
Country 89371 0
Australia
Phone 89371 0
+61 2 9385 3310
Fax 89371 0
Email 89371 0
[email protected]
Contact person for scientific queries
Name 89372 0
Travis Wearne
Address 89372 0
1309 Mathews Building
School of Psychology
University of New South Wales
Kensington
NSW, 2052
Country 89372 0
Australia
Phone 89372 0
+61 2 9385 3310
Fax 89372 0
Email 89372 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be made available in line with the journal requirements as dictated by their data sharing policy. We will amend this response once this has been decided (and when the journal has been decided).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRegulating emotion following severe traumatic brain injury: a randomized controlled trial of heart-rate variability biofeedback training.2021https://dx.doi.org/10.1080/02699052.2021.1972337
N.B. These documents automatically identified may not have been verified by the study sponsor.