None listed
Conditions
Brief summary
Fatigue occurs in around 50% of individuals post-stroke often co-existing with sleep problems, which contribute to fatigue. Fatigue is further correlated with cognitive and functional disability and is associated with depression, anxiety, pain, sleep disturbance, unemployment and reduced quality of life. Despite this, there has been little empirical investigation into the management of fatigue and sleep disturbance following stroke and no treatments are indicated for use following stroke. Pharmacotherapy is ineffective in the long-term and may cause adverse effects. Graded exercise has shown modest gains in fatigue post-stroke. A review of chronic fatigue syndrome treatment studies concluded graded exercise and CBT were effective, but CBT was more effective where anxiety and depression were also present. To date there have been no controlled trials of CBT addressing fatigue and sleep disturbance following stroke. If successful, CBT for fatigue and sleep will result in reductions in fatigue, improved sleep quality, increased activity levels and thus improved quality of life and functional outcomes.
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 30 min assessment with an exercise physiologist (EP) to establish a baseline of achievable physical activity, aiming for 30 minutes of moderate exercise (walking, exercise bike, swimming) 3-5 times per week, wearing a heart rate monitor. Participants discuss with the EP which physical activities they prefer and the number of sessions that best fit with their current schedules. 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
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 70 Years
Healthy volunteers
No
Inclusion criteria
Participants aged 17 to 70 years with history of stroke and clinically significant self-reported fatigue (Fatigue Severity Scale [FSS] equal or above 4) and/or poor sleep (Pittsburgh Sleep Quality Index [PSQI] above 5). They need to 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
Exclusion criteria are co-morbid neurological disorders, acute psychiatric symptoms or substance abuse, transmeridian travel or night shift work in the previous month and current sleep apnea.
Outcome results
None listed