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Cognitive-Behavioural Therapy for sleep disturbance and fatigue following stroke

Efficacy of Cognitive-Behavioural Therapy for sleep disturbance and fatigue following stroke

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000879369
Enrollment
126
Registered
2017-06-15
Start date
2017-06-30
Completion date
2022-10-04
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sleepiness and fatigue are frequent debilitating problems following stroke. 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 sleep disturbance after stroke. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with another group of participants receiving 8 sessions of health education for issues specifically related to stroke.

Interventions

Cognitive-Behavioural Therapy for sleep and fatigue (CBT-SF): CBT-SF will consist of 8 one hour sessions conducted weekly either in-person or via tele-health using Zoom, 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 activi

Cognitive-Behavioural Therapy for sleep and fatigue (CBT-SF): CBT-SF will consist of 8 one hour sessions conducted weekly either in-person or via tele-health using Zoom, 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.

Sponsors

Monash University
Lead SponsorUniversity

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 72 Years
Healthy volunteers
No

Inclusion criteria

Participants aged 17 to 72 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.

Exclusion criteria

Participants will have no history of other neurological disorder, pre-injury sleep disorder or chronic fatigue syndrome requiring treatment. They will have no obesity based on body mass index greater than 31, no transmeridian travel across more than 1 time zone or nightshift work in the preceding 6 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. 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. The nature of any concurrent therapies will be documented.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026