None listed
Conditions
Brief summary
This clinical trial looks into investigating the effectiveness of a novel group intervention programme for mild traumatic brain injury (mTBI or concussion) to help us provide better clinical care. The study involves a three-part intervention programme comprising 1) a neuropsychological examination measuring different aspects of cognition; 2) 6x1.5-hour weekly group sessions covering a range of information about mTBI, including skills that you can use to assist with recovery; and 3) up to 6x1-hour weekly individual sessions, in which some of the issues specific to your recovery will be addressed. Participants will also be asked to fill out a range of questionnaires at pre- and post-intervention, as well as a remotely administered 3-month follow-up, to track recovery progress.
Interventions
The current intervention program under investigation for this study is designed to be a comprehensive group- and individual-based intervention for reducing psychological and cognitive post-concussive symptoms associated with mild traumatic brain injury (mTBI) or concussion, with the goal of improving quality of life via an uncontrolled (single-arm) non-randomised clinical trial design. Rationale: Most people with mTBI do not usually receive targeted intervention to this degree, and this study will investigate the feasibility and effectiveness of offering a higher level of care as an adjunct to standard treatment. Participants will be aged 18-70 years and have had an mTBI between 6 weeks and 12 months ago. The intervention program comprises of two main components and an optional third component (offered on an as-needed basis). The first component is a 1:1 F2F neuropsychological examination conducted by a registered psychologist on site at The University of Melbourne, Parkville Campus/The University of Melbourne Psychology Clinic. This process includes a clinical interview and psychometric assessment, broadly examining the functioning of the various core domains of cognition (e.g., processing speed, attention, memory, executive function etc.) Participants will then receive personalized feedback regarding the findings of this assessment, as well as targeted psychoeducation and assistance in the management of ongoing cognitive difficulties. At this time, participants will also complete a range of questionnaires to examine factors including psychiatric and cognitive symptoms, psychosocial variables, and functional outcome. The second component of the intervention program comprises a F2F novel group intervention program that utilises a range of evidence-based approaches (e.g., psychoeducation and CBT) from clinical neuropsychology and clinical psychology to address the various common mTBI-related concerns, such as fatigue, low mood and worry, and adjusting to cognitive impairment. This novel group program will be comprise of 6 sessions conducted on site at The University of Melbourne, Parkville Campus/The University of Melbourne Psychology Clinic - x1 session weekly, depending on group availability and scheduling. The goal is to complete all 6 sessions within 6-12 weeks. The novel group intervention program is designed to be run in a small group setting (8-10 max capacity). During these group sessions, participants, led by a registered psychologist, will be working through the material and content designed by the researchers. To facilitate content delivery and discussions, PowerPoint slides and various handouts will be used. Each week's activities/discussions will focus on learning about a specific topic related to mTBI and brain injury recovery as well as learning about the various strategies to cope with the related symptoms. The following is a broad overview of the content of each session: Week 1: Introduction to the program, Introduction to mild traumatic brain injury (mTBI) Week 2: Introduction to mTBI cont Week 3: Sleep and fatigue Week 4: Mood and worry Week 5: How to adjust to this change Week 6: Frustration and change in life situation There will be an attendance protocol to track engagement with the intervention as well as handouts/homework tasks designed by researchers to complement the psychoeducation and learning of each week. Broadly, the material will cover a range of strategies, such as behavioral activation, fatigue monitoring, progressive muscle relaxation, relaxed breathing, thought record, emotional wheel, frustration triggers, etc. Upon completion of the 6 group sessions, all outcome questionnaires will be re-administered. Should the participant indicate that they require further interventional support after completing the group program, the treating psychologist can offer the option to complete up to six one-hour F2F individual sessions. This third component of the study is optional and evaluated clinically on an as-needed basis, depending on the needs of the participant. Questionnaires will be repeated to evaluate the outcome of this component of the program. Broadly, these 1:1 sessions draw on the same content and intervention principles of the group program, aiming to reinforce the content and strategies learned in group on a more individualized basis. All personnel working on this project are AHPRA-registered psychologists: x1 AHPRA Registered Psychologist (Neuropsychology Registrar) under the direct clinical supervision of x1 AHPRA-registered Clinical Neuropsychologist and x1 registered AHPRA Clinical Psychologist. Collectively, all psychologists on this project are experienced in working clinically and in research with neurological conditions/head injuries (e.g., concussions). The psychologists are also trained as part of the conditions of registration to be able to perform neuropsychological assessment (psychometric testing and clinical interpretation + delivering feedback) and neurocognitive/rehab intervention, as well as psychological intervention (e.g., CBT, psychoeducation, etc.).
Sponsors
Study design
Eligibility
Inclusion criteria
Individuals (all gender/sexes) aged 18-60 with a Mild Traumatic Brain Injury. An mTBI event will be defined as: i) 1 or more of: confusion or disorientation, loss of consciousness for 30 minutes or less, post-traumatic amnesia less than 24 hours, and/or other transient neurological abnormalities not requiring surgery; ii) Glasgow Coma Scale score of 13-15 after 30 minutes or later upon presentation for healthcare.
Exclusion criteria
To be eligible for the study, the following must be met: - No ongoing severe psychiatric disorder (e.g., psychotic, bipolar disorder, suicide attempt). - No acute or severe (significantly impacting functional performance) psychiatric symptoms in the past 4 weeks at first contact and follow-up. - No current drug use (i.e., within the last 12 months) evaluated using the Drug Use Disorder Identification Test (DUDIT). On screening with DUDIT, current drug use within 12 months can be included as long as the meet the following conditions: women must not have score of 2 or more & men must not have score of 6 or more. Participants with DUDIT score that exceeds these conditions will not be eligible to participate. - No current IV drug use (i.e., within the last 12 months). History of IV drug use permitted to enroll in study. - No current heavy ETOH (no more than 6 standard drinks per day on a daily basis). - No previous TBI of moderate or severe severity without full recovery. - Non fluency in the English language - No more than 10 previous mTBIs - No chronic pain pre-injury - No chronic sleep disturbance- e.g., diagnosed sleep disorder (pre-injury) - No neurological disorder that affects cognition (e.g., MS, brain tumours, epilepsy etc.)