Category
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Primary study
Registry of Trials»ANZCTR
Year
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2017
INTERVENTION: Cognitive‐Behavioural Therapy for sleep and fatigue (CBT‐SF): CBT‐SF will consist of 8 one hour sessions conducted weekly, focused on reducing and preventing sleep disturbance and fatigue. Sleep is addressed in sessions 1, 2, 5, 6 and 8 and fatigue in sessions 1, 2, 3, 4, 7 and 8. Session 1 will include psycho‐education about post‐stroke sleep disturbance and fatigue, including how poor sleep habits relate to fatigue. Self monitoring of daily activities and subjective fatigue levels will be initiated to encourage understanding of the link between activity levels and fatigue. Participants will be encouraged to engage in regular cardiovascular exercise as a form of behavioural activation. In session 2, the self‐monitoring diary will be reviewed to encourage participants to regulate their activity schedule to balance rest and activity and sleep hygiene practices promoted. Traditional CBTi elements including stimulus control and sleep restriction are introduced, monitored through sleep diaries and reinforced in subsequent sessions. Sessions 3 and 4 will focus on gradually increasing or decreasing activity levels depending on goals. Cognitive therapy is used to address maladaptive thoughts underpinning behaviours that reinforce fatigue and disturbed sleep patterns. Session 5 will provide sleep education, including sleep need, sleep stages, circadian rhythms, homeostatic pressure, model of insomnia and include detailed discussion of sleep restriction, stimulus control and sleep hygiene recommendations and how these can be implemented for the participant. Adherence to new bedtime schedules and better sleep practices is reviewed at subsequent sessions. Cognitive interventions for insomnia (cognitive restructuring, imagery and visualisation) and behavioural interventions for insomnia (stimulus control, sleep restriction, constructive worry sheet and progressive muscle relaxation) will be addressed in Session 6. In Session 7 the focus will be on practical strategies to manage information overload and minimize physical and mental fatigue. The last session will promote long‐term gains by reviewing therapeutic techniques, troubleshooting lingering concerns and establishing relapse prevention plans. The intervention has been manualized to ensure consistency of approach. Participants will continue whatever medical, psychological or rehabilitative interventions they are otherwise receiving. The therapy will be individual and carried out face‐to‐face by Clinical Psychologists/Neuropsychologists with experience in CBT and understanding of stroke. They will be supervised by a psychologist expert in CBTi (Moira Junge). 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. CONDITION: Fatigue Sleep disturbance Stroke PRIMARY OUTCOME: Pittsburgh Sleep Quality Index (PSQI) 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. SECONDARY OUTCOME: Brief Fatigue Inventory (BFI) Epworth Sleepiness Scale (ESS) Fatigue Severity Scale (FSS) 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. Hospital Anxiety and Depression Scale (HADS) depression scores Insomnia Severity Index (ISI) Mean sleep efficiency (percentage of sleep time/time sleep in bed) based on actigraphy and supported by self‐report sleep diaries. Percentage of time spent in productive activity from self report activity diaries. Productive activity is defined as any meaningful activity including paid or unpaid employment or study, sporting, recreational or social activities, family participation, or personal, domestic, or community activities of daily living, but not including resting activities. SF‐36v2 Health Survey (SF‐36v2) Self efficacy scale scores Sleep onset latency based on actigraphy
Epistemonikos ID: 7f4958dd21521e2af6fd48317c55a61c117cf9ee
First added on: Aug 25, 2024