Cognitive behavioural therapy for post-stroke fatigue and sleep disturbance: a pilot randomised controlled trial with blind assessment

ABSTRACT

The objective of this study was to evaluate the effectiveness of individual cognitive behavioural therapy (CBT) for post-stroke fatigue and sleep disturbance compared to treatment as usual (TAU). In a parallel two-group pilot randomised controlled trial of 15 participants, nine were allocated to eight weekly sessions of adapted CBT and six continued usual care rehabilitation. The primary outcome was the Fatigue Severity Scale (FSS-7) at two and four months from baseline. Secondary outcomes included measures of sleep, mood and quality of life. Outcomes were assessed by a rater who was blind to group membership. At the four-month endpoint, the CBT group demonstrated significantly reduced fatigue relative to TAU (FSS-7 mean difference: 1.92, 95% CI: 0.24 to 3.60). Significant group differences also emerged for sleep quality and depression, favouring the CBT group. Insomnia and physical quality of life improved immediately post-therapy but were no longer superior to TAU at follow-up. Overall, CBT is a promising treatment for improving post-stroke fatigue, sleep quality and depression. Gains were maintained for two months after therapy cessation and represented large treatment effects. These findings highlight the feasibility of the intervention and warrant extension to a phase III clinical trial.

KEYWORDS:

• Stroke
• fatigue
• insomnia
• cognitive behavioural therapy
• rehabilitation

Acknowledgements

The authors wish to thank Dr Kate Frencham (one of the three therapists) for delivering the intervention, Dr Moira Junge and Dr Kerrie Haines for providing clinical supervision and rating treatment fidelity, Dr Lisa Johnston for managing the randomisation process, Ms Jacqueline Owens for completing the follow-up interviews and Ms Jacqueline Waite for conducting exercise assessments. We are also thankful to all the participants involved in the study.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by the NHMRC Moving Ahead Centre of Research Excellence in Brain Recovery under [Grant 1023043] and the Epworth Research Institute under [Grant 80969].