Evaluation of an Interdisciplinary Intervention for Chronic Concussion Symptoms

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 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 be offered 8 sessions each of psychological and physiotherapy treatment over 12 weeks as required based on the initial interviews (face‐to‐face or Telehealth). 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. If necessary they can be spread out to fortnightly. 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, ve CONDITION: Concussion;Post‐Concussion Syndrome;Traumatic Brain Injury; ; Concussion ; Post‐Concussion Syndrome ; Traumatic Brain Injury Injuries and Accidents ‐ Other injuries and accidents Neurological ‐ Other neurological disorders Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation Physical Medicine / Rehabilitation ‐ Physiotherapy PRIMARY OUTCOME: Post‐concussion symptoms as measured by the Rivermead Post‐Concussion Symptoms questionnaire.[T1= Start of Baseline, Baseline, Intervention, T2 = post‐intervention (primary timepoint), T3 = 1‐month follow‐up, T4= 3‐month follow‐up.; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention.; ; During baseline and intervention phases, participants will complete the Rivermead Post‐Concussion Symptoms questionnaire 3 times a week via an online survey.] SECONDARY OUTCOME: Fatigue as assessed by the Brief Fatigue Inventory and the Fatigue Severity Scale.[T1= Start of Baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention.] Health related quality of life as assessed by the 36‐Short form[T1= Start of Baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention. ; ; ; ; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention. ; ] Sleep disturbance as assessed by the Insomnia Severity Index[T1= Start of baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention. ; ] Symptoms of anxiety as assessed by the Depression Anxiety and Stress Scales‐21[T1= Start of Baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; ] Health Service Utilisation assessed by collecting quantity of visits/number of times accessed for a range of health services by each participant. These health services include: medication, physiotherapy, occupational therapy, psychology, GP, paid care, unpaid care, community or social care services and hospital admissions.[T1= Start of Baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention.] Return to activity as assessed by Goal Attainment Scaling[Intervention, Post‐intervention (T2) and 1‐month follow‐up (T3) ; GAS goals will be assessed multiple times within the intervention. GAS goals will be established in Session 2 of the psychological intervention. GAS goals will be reviewed weekly from Sessions 4‐8 of the psychological intervention. ; Post intervention will be defined as within 1‐week post‐intervention.] Satisfaction with Social Roles and Activities assessed by the the Traumatic Brain Injury Quality‐of‐Life.[T1= Start of Baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention.] Symptoms of stress as assessed by the Depression Anxiety and Stress Scales‐21[T1= Start of Baseline, T2 = post‐intervention, T3 = 1‐month follow‐up, T4= 3‐month follow‐up. ; ; Start of baseline is defined as one day prior to baseline. Post intervention will be defined as within 1‐week post‐intervention. ; ] The Working Alliance Inventory‐Short Revised (WAI‐SR) to assesses key aspects of clinician rapport.[Post intervention, defined as within 1‐week post‐intervention.] INCLUSION CRITERIA: Individuals will be included in the study if they have sustained a mild traumatic brain injury classified as having a Glasgow Coma Scale (GCS) score between 13 and 15, less than 30 minutes of loss of consciousness, and experienced less than 24 hours of post traumatic amnesia (PTA), and have persisting post‐concussion symptoms (>3 post‐concussion symptoms persisting for at least 1 month; Tator et al., 2016) assessed on the Rivermead Post‐Concussion Symptoms questionnaire. Individuals must be at least four weeks post injury but less than 12 months post injury to ensure that symptoms are no longer acute but are current and persistent (Tomfohr‐Madsen et al., 2019).
Epistemonikos ID: 44251972aec89a99aad98298322ca4eb1c23877f
First added on: Aug 25, 2024