None listed
Conditions
Brief summary
Sleepiness and fatigue are frequent debilitating problems following traumatic brain injury (TBI). Medications have not provided long-term solutions for these symptoms and there is little research into psychological treatments. Cognitive Behaviour Therapy (CBT) is a well-established treatment for insomnia and chronic fatigue in those without a brain injury. The Monash-Epworth Rehabilitation Research Centre is conducting a world first study to investigate whether CBT can be effectively adapted to reduce symptoms of fatigue and sleepiness after TBI. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with a neuropsychologist to waitlisted participants who receive routine care as usual.
Interventions
The intervention will consist of 8 one-hour individual sessions of Cognitive Behavioural Therapy (CBT) conducted weekly, focused on reducing and preventing sleep disturbance and fatigue. The therapists are Clinical Neuropsychologists with doctoral qualifications, advanced training in CBT and experience working with a brain-injured cohort. Treatment is delivered according to a standardised treatment manual developed specifically for the study and adapted for cognitive impairments common to brain injury. Treatment fidelity and adherence to protocol will be assessed by audio taping all sessions; a random sample of 10% of sessions will be rated by an independent assessor expert in CBT. They will be supervised by a psychologist expert in CBT-i (CBT for insomnia) to maintain and improve fidelity. Therapy sessions are to be conducted at clinic rooms at Epworth Richmond, Monash Clayton or at the participant's home. Participants will be also encouraged to engage in regular cardiovascular exercise in their target heart range (i.e. 60-80% of their maximum heart rate) to enhance their aerobic fitness and as a form of behavioural activation. They have a one-off assessment with an exercise physiologist (EP) between the 1st and 3rd therapy session (when behaviour activation is addressed). Participants discuss with the EP which physical activities they prefer (e.g walking, exercise bike, swimming) and the number of sessions that best fit with their current schedules but generally participants will be instructed to aim for 30 minutes of moderate exercise 3-5 times per week for 8 weeks, wearing a heart rate monitor to ensure they achieve their target heart rate range. Participants will undergo a repeat assessment post-treatment to determine if there are any changes in cardiovascular fitness. A step count pedometer is provided at each follow up as a basic measure of level of average physical activity across the week. This also provides an indication of adherence to exercise guidelines.
Sponsors
Professor Jennie Ponsford
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
17 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants with mild to severe TBI and self-reported sleep disturbance (PSQI greater than 5 and/or fatigue (FSS or BFI equal or greater than 4), recruited via Epworth Hospital after return to the community. Participants will have a history of blunt head trauma with LOC, initial GCS of 3-14 and/or a period of PTA. They will be aged 17-65 years and have adequate English skills, cognitive ability, visual acuity and physical ability to complete the questionnaires and therapy, as assessed by their treating neuropsychologist and live within a one-hour radius of the hospital.
Exclusion criteria
They will have no history of other neurological disorder, no transmeridian travel across >1 time zone or nightshift work in the preceding 4 weeks, no current use of psychotropic medication illicit drugs or medication affecting sleep or causing fatigue, such as benzodiazepines or hypnotics and no need for surgery during the study period. They will be excluded if screening shows high risk of Obstructive Sleep Apnoea (OSA) which also causes sleep disturbance, EDS and mood changes. They will be permitted to continue whatever medical, psychological or rehabilitative treatment they are receiving, including pharmacological treatment, other than benzodiazepines or hypnotics, provided that the treatment regimen/dose is stable and does not change throughout the study treatment period.
Outcome results
None listed