Randomized controlled trial of cognitive behavioral therapy versus health education for sleep disturbance and fatigue following stroke and traumatic brain injury.

Objective: Evaluate efficacy of cognitive behavioural therapy for sleep and fatigue adapted for brain injury relative to health education control in alleviating sleep disturbance and fatigue after acquired brain injury.

Design: Parallel groups randomized controlled trial.

Subjects: 126 community dwelling adults with stroke or traumatic brain injury.

Methods: Participants were randomized 2:1 to receive 8-weeks of cognitive behavioural therapy for sleep and fatigue (n = 86) or health education (n = 40). The Pittsburgh Sleep Quality Index was assessed pre- and post-treatment, and 2 and 4-months post-treatment, with secondary measures of insomnia, fatigue, sleepiness, mood, quality of life, activity levels, self-efficacy, and actigraphy.

Results: Both groups showed improved sleep by 4-month follow-up. However, cognitive behavioural therapy for sleep and fatigue had significantly larger and more rapid improvements than health education immediately post-treatment (β = -1.50, p < 0.001, 95% confidence interval -2.35 to -0.64). There were no significant between-groups differences in fatigue; however, cognitive behavioural therapy for sleep and fatigue showed within-group gains on both fatigue measures immediately post-treatment and over time (β = -0.29, p = 0.047, 95% confidence interval -0.58 to -0.01). Health education had delayed improvements at 4-month follow-up on 1 fatigue measure.

Conclusions: Both cognitive behavioural therapy for sleep and fatigue and health education led to improvement in sleep and fatigue; however, effects were larger and more rapid for cognitive behavioural therapy for sleep and fatigue immediately post-treatment. This supports the efficacy of cognitive behavioural therapy for sleep and fatigue in acquired brain injury but also highlights that health education may result in delayed improvements in symptoms. ANZCTR Trial registration numbers: 1261700087830; 12617000879369.