Cognitive behavioural therapy versus health education for sleep disturbance and fatigue after acquired brain injury: a pilot randomised trial

Abstract Background Sleep disturbance and fatigue are highly prevalent after acquired brain injury (ABI) and are associated with poor functional outcomes. Cognitive behavioural therapy (CBT) is a promising treatment for sleep and fatigue problems after ABI, although comparison with an active control is needed to establish efficacy. Objectives We compared CBT for sleep disturbance and fatigue (CBT-SF) with a health education (HE) intervention to control for non-specific therapy effects. Methods In a parallel-group, pilot randomised controlled trial, 51 individuals with traumatic brain injury (n = 22) and stroke (n = 29) and clinically significant sleep and/or fatigue problems were randomised 2:1 to 8 weeks of a CBT-SF (n = 34) or HE intervention (n = 17), both adapted for cognitive impairments. Participants were assessed at baseline, post-treatment, and 2 and 4 months post-treatment. The primary outcome was the Pittsburgh Sleep Quality Index; secondary outcomes included measures of fatigue, sleepiness, mood, quality of life, activity levels, self-efficacy and actigraphy sleep measures. Results The CBT-SF led to significantly greater improvements in sleep quality as compared with HE, during treatment and at 2 months [95% confidence interval (CI) -24.83; -7.71], as well as significant reductions in fatigue maintained at all time points, which were not evident with HE (95% CI -1.86; 0.23). HE led to delayed improvement in sleep quality at 4 months post-treatment and in depression (95% CI -1.37; -0.09) at 2 months post-treatment. CBT-SF led to significant gains in self-efficacy (95% CI 0.15; 0.53) and mental health (95% CI 1.82; 65.06). Conclusions CBT-SF can be an effective treatment option for sleep disturbance and fatigue after ABI, over and above HE. HE may provide delayed benefit for sleep, possibly by improving mood. Trial Registration Australia New Zealand Clinical Trials Registry: ACTRN12617000879369 (registered 15/06/2017) and ACTRN12617000878370 (registered 15/06/2017).