None listed
Conditions
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"
Interventions
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 p
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.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
17 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed