Randomized controlled trial of cognitive behavioural therapy versus health education for sleep disturbance and fatigue following stroke and traumatic brain injury
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 126 participants or records.
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