RecruitingACTRN12622000702718

Evaluation of an Interdisciplinary Intervention for Chronic Concussion Symptoms

Evaluation of an Interdisciplinary Intervention for Persistent Post-Concussion Symptoms in Individuals who have Experienced a Mild Traumatic Brain Injury


Sponsor

Monash University

Enrollment

66 participants

Start Date

Feb 7, 2023

Study Type

Interventional

Conditions

Summary

Concussion is the most common form of brain injury, making up 75-90% of all brain injuries. Concussions generally resolve within 7-10 days, however, up to 25% experience delayed recovery which may interfere with return to pre-injury activities (e.g. work) and cause significant stress for months and sometimes years after injury. Persisting concussion symptoms are thought to reflect a range of factors beyond the original injury to the brain including stress and anxiety and physical factors such as injury to the neck, visual and/or balance systems. Given that multiple factors may be contributing to the persistence of symptoms after concussion, an interdisciplinary approach to management is now recommended in clinical practice. Therefore, we aim to conduct a randomised controlled trial and evaluate an interdisciplinary intervention that incorporates expertise from psychology, physiotherapy, and medicine to target the primary factors thought to contribute to persisting concussion symptoms.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Concussion is the most common type of brain injury, and most people recover fully within one to two weeks. However, about one in four people experience symptoms that persist for months or even years — things like headaches, brain fog, dizziness, fatigue, anxiety, and difficulty concentrating. These persisting symptoms are thought to result from a mix of factors including the initial brain injury, stress, neck injuries, and problems with the visual or balance systems. Because multiple things can contribute to slow recovery, this study tests an interdisciplinary treatment combining expertise from psychology, physiotherapy, and medicine. The programme is tailored to each person's specific symptom profile and is compared to a control condition in a randomised trial to find out whether this combined approach is more effective than existing individual treatments. You may be eligible if you are between 16 and 70 years old, sustained a mild traumatic brain injury, have had more than three ongoing post-concussion symptoms for at least two weeks, and are between two weeks and three years since your injury. People with active psychiatric conditions, substance abuse, significant neurological history, or insufficient English are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants in the intervention group will receive intervention from a neuropsychologist, physiotherapist, and sports medicine physician. All participants will receive an initial 60-minute consultati

Participants in the intervention group will receive intervention from a neuropsychologist, physiotherapist, and sports medicine physician. All participants will receive an initial 60-minute consultation with these clinicians. The initial consultations will take place either face-to-face or via telehealth. Following initial consultations, clinicians will meet via case conference to discuss individualised treatment plans. Participants will then be offered weekly sessions of psychological and physiotherapy treatment across an 8 week period (face-to-face or Telehealth). Including the initial treatment session, 8 treatment sessions will be offered for each of neuropsychology and physiotherapy i.e. a total of 16 sessions of treatment will be offered. Treatment sessions will be provided in a one-on-one setting. Psychological treatment sessions will last between 60-90 minutes at a maximum of once a week. Physiotherapy treatment sessions will last for 45-60 minutes and will be at a maximum of once a week. The psychological intervention will be oriented toward a cognitive-behavioural framework as described by Beck (1979). The intervention will use the treatment manual developed in the pilot phase of this research (ACTRN12620001111965) adapted from previous manuals developed by Ferguson and Mittenberg (1996) and Silverberg et al. (2013). The treatment manual includes psychoeducation, activity scheduling, cognitive restructuring, anxiety management training, and sleep intervention components. As part of this therapy, participants will be provided with educational materials including worksheets and handouts which were also developed in the pilot phase of this research. Participants will also be assessed by a physiotherapist and will be provided treatment in the following domains as required: ocular, vestibular, cervical, and autonomic system functioning. Physical therapy intervention will be specific to their assessment and may comprise of vestibular rehabilitation, manual therapy, cervical strengthening and proprioceptive training and a graded exercise program. Examples of ocular retraining include convergence exercises where participants will watch a target as it moves towards them, saccadic retraining where participants quickly move their gaze between targets, and smooth pursuit training where the participant watches a moving target such as a swinging ball. Examples of vestibular rehabilitation are gaze stabilisation where participants turn their head and focus on a target (this is done to a particular speed predetermined by the physiotherapy assessing the participant), VOR cancellation exercises where participants watch a target move through space by turning their whole body, and motion sensitivity exercises such as ball skills, walking, and gaze stabilisation or VOR cancellation. Examples of cervical rehabilitation include cervical strengthening such as deep neck flexor strengthening, proprioception training with a target and a laser to rehabilitate sensory awareness of the neck, and manual work on the neck by the physiotherapist. Graded exercise is defined as exercise of the participant's choice that can be safely done for 20 minutes. Exercise will be targeted at a particular heart rate. The starting heart rate will be defined as 80% of the point of failure of the subject on the treadmill test. Heart rates will increase in line with a decrease in participant's symptoms. This will be assessed and closely monitored by the physiotherapist. Graded exercise will generally be walking, running or stationary bike, however, other modes such as swimming could be introduced if tolerated and preferred by the participant. The physiotherapist will outline an individualised treatment and home program based on the assessment. Medical management of persistent post-concussion symptoms will comprise of one consultation (same as initial consultation) with the physician which may include pharmacological management of symptoms as well as advice regarding return to activities (e.g. work, sport, school). Treatment fidelity: Adherence to the manualised CBT intervention will be rated by an independent psychologist who will listen to audio/video recordings of 10% of the sessions.


Locations(1)

VIC, Australia

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