A blended eHealth intervention for insomnia following acquired brain injury: a randomised controlled trial.

The high prevalence and severe consequences of poor sleep following acquired brain injury emphasises the need for an effective treatment. However, treatment studies are scarce. The present study evaluates the efficacy of blended online cognitive behavioural therapy for insomnia (eCBT-I) developed specifically for people with acquired brain injury. In a multicentre prospective, open-label, blinded end-point randomised clinical trial, 52 participants with insomnia and a history of a stroke or traumatic brain injury were randomised to 6 weeks of guided eCBT-I or treatment as usual, with a 6-week follow-up. The primary outcome measure was the change in insomnia severity between baseline and after treatment, measured with the Insomnia Severity Index. Results showed that insomnia severity improved significantly more with eCBT-I than with treatment as usual compared to baseline, both at post-treatment (mean [SEM] 4.0 [1.3] insomnia severity index points stronger decrease, d = 0.96, p < 0.003) and at follow-up (mean [SEM] 3.2 [1.5] insomnia severity index points, d = -0.78, p < 0.03). In conclusion, our randomised clinical trial shows that blended CBT is an effective treatment for insomnia, and feasible for people with acquired brain injury, regardless of cognitive and psychiatric complaints. Online treatment has major advantages in terms of availability and cost and may contribute to the successful implementation of insomnia treatment for people with acquired brain injuries.

Can people with poststroke insomnia benefit from blended cognitive behavioral therapy? A single case experimental design.

PURPOSE: Sleep is essential for our overall health and wellbeing. Unfortunately, stroke often induces insomnia, which has been shown to impede rehabilitation and recovery of function. Cognitive behavioral therapy for insomnia (CBT-I) is the treatment of choice for insomnia in the general population and is efficacious both when delivered face-to-face or online. The primary aim of this study was to evaluate efficacy of blended CBT-I (eCBT-I) in five poststroke participants with insomnia according to DSM-5 criteria. METHODS: A randomized multiple baseline design was used to evaluate improvements in total sleep time, sleep onset latency, sleep efficiency, nocturnal awakenings and sleep quality. The intervention included six weeks of eCBT-I combined with two face-to-face sessions. RESULTS: All participants completed the intervention. One participant stopped using the diary, while the other four completed it fully. All five sleep diary measures improved, significantly so for nocturnal awakenings. Moreover, after completion of the treatment, four out of five participants no longer fulfilled DSM-5 criteria for insomnia disorder. CONCLUSIONS: This is the first study to show that blended CBT-I is potentially effective in participants with post-stroke insomnia. The findings justify extension to a randomized controlled trial.

A blended eHealth intervention for insomnia following acquired brain injury: study protocol for a randomized controlled trial.

BACKGROUND: Up to a third of stroke patients and patients with traumatic brain injury suffer from insomnia, including problems to fall asleep or stay asleep at night. Insomnia may exacerbate other brain damage-related problems, for example regarding cognitive functioning and emotional well-being; may lead to poorer quality of life; and may complicate recovery processes. Cognitive behavioral therapy for insomnia, delivered face-to-face or online, is found to be effective in the general population. However, despite the high prevalence and serious consequences of insomnia following acquired brain injury, studies on the efficacy of face-to-face cognitive behavioral treatment in this population are scarce, and this applies even more for studies on online cognitive behavioral therapy. Therefore, this study aims to evaluate the efficacy of a newly developed guided online cognitive behavioral therapy for insomnia following acquired brain injury. METHODS: A multicenter, prospective, randomized, open-label, blinded end point study (PROBE) will be conducted, in which 48 patients diagnosed with stroke or traumatic brain injury and insomnia will be randomly allocated to the online cognitive behavioral therapy for insomnia treatment group or the treatment as usual group. The treatment consists of 6 online cognitive behavioral therapy sessions given on a weekly basis and personalized feedback after each session, combined with 2 face-to-face sessions. Outcomes will be assessed at baseline, immediately after the intervention period and at 6-week follow-up. The primary outcome is the insomnia severity assessed with the Insomnia Severity Index. Secondary outcome measures include sleep quality, sleep features derived from the sleep diary, fatigue, anxiety and depression, subjective cognitive functioning, and societal participation. DISCUSSION: This study will provide insight on the efficacy of online cognitive behavioral therapy for insomnia following stroke and traumatic brain injury. TRIAL REGISTRATION: Netherlands Trial Register NTR7082 . Registered on 12 March 2018.

Non-pharmacological treatment for insomnia following acquired brain injury: A systematic review.

Insomnia symptoms following acquired brain injury are serious and common, associated with cognitive and emotional complaints. This systematic review aims to summarize and appraise the current knowledge regarding the efficacy of non-pharmacological treatments for insomnia after traumatic brain injury and stroke in adults. A systematic search in the electronic databases of Medline, PsycINFO and Embase was conducted on January 15, 2019. The search strategy included traumatic brain injury or stroke and a combination of keywords and Boolean operators to represent the concept of insomnia. Articles were restricted to those in English and study populations of human adults. A total of 4341 studies were found, of which 16 were included, representing seven different non-pharmacological treatments. While the quality and quantity of the studies does not allow for firm conclusions, the outcomes suggest that cognitive behavioural therapy improves insomnia and sleep quality. The results highlight the need for larger studies of better methodological quality on non-pharmacological interventions for insomnia following brain injury.

Are the effects of internal focus instructions different from external focus instructions given during balance training in stroke patients? A double-blind randomized controlled trial.

OBJECTIVE:: This study aimed to assess if external focus instructions result in greater improvements in motor skill and automaticity compared to internal focus instructions in stroke patients. DESIGN:: Double-blind randomized controlled trial. SETTING:: Inpatient stroke rehabilitation unit. SUBJECTS:: A total of 63 stroke patients (Meanage = 59.6 ± 10.7 years; Meandays since stroke = 28.5 ± 16.6; MedianFunctional Ambulation Categories = 4). INTERVENTIONS:: Patients were randomly assigned to an internal ( N = 31) or external ( N = 32) focus instruction group. Both groups practiced a balance board stabilization task, three times per week, for three weeks. Balance performance was assessed at baseline, and after one and three weeks of practice. MAIN MEASURES:: Primary outcome was the threshold stiffness (Nm/rad) at which patients could stay balanced. Secondary outcomes were patients' sway (root-mean-square error in degrees) at the baseline threshold stiffness under single- and dual-task conditions, and their performance on the Timed Up and Go Test and Utrecht Scale for Evaluation of Rehabilitation. RESULTS:: Both groups achieved similar improvements in threshold stiffness (∆= 27.1 ± 21.1 Nm/rad), and single- (∆= 1.8 ± 2.3° root-mean-square error) and dual-task sway (∆= 1.7 ± 2.1° root-mean-square error) after three weeks of practice. No differences were found in improvements in clinical tests of balance and mobility. Patients with comparatively good balance and sensory function, and low attention capacity showed greatest improvements with external focus instructions. CONCLUSION:: External focus instructions did not result in greater improvement in balance skill in stroke patients compared to internal focus instructions. Results suggest that tailoring instructions to the individual stroke patient may result in optimal improvements in motor skill.

Effects of Continuous Positive Airway Pressure on Cognitive and Functional Outcome of Stroke Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) in stroke patients is associated with worse functional and cognitive status during inpatient rehabilitation. We hypothesized that a four-week period of continuous positive airway pressure (CPAP) treatment would improve cognitive and functional outcomes. METHODS: We performed a randomized controlled trial in stroke patients admitted to a neurorehabilitation unit. Patients were assigned to rehabilitation treatment as usual (control group) or to CPAP treatment (CPAP group). Primary outcomes were cognitive status measured by neuropsychological examination, and functional status measured by two neurological scales and a measure of activities of daily living (ADL). Secondary measures included sleepiness, sleep quality, fatigue, and mood. Tests were performed at baseline and after the four-week intervention period. RESULTS: We randomly assigned 20 patients to the CPAP group and 16 patients to the control group. The average CPAP compliance was 2.5 hours per night. Patients in the CPAP group showed significantly greater improvement in the cognitive domains of attention and executive functioning than the control group. CPAP compliance was associated with greater improvement in cognitive functioning. CPAP did not result in measurable improvement on measures of neurological status or ADL, or on any of the secondary measures. CONCLUSIONS: CPAP treatment improves cognitive functioning of stroke patients with OSA. COMMENTARY: A commentary on this article appears in this issue on page 467.

The effect of computer-based cognitive flexibility training on recovery of executive function after stroke: rationale, design and methods of the TAPASS study.

BACKGROUND: Stroke survivors frequently suffer from executive impairments even in the chronic phase after stroke, and there is a need for improved rehabilitation of these functions. One way of improving current rehabilitation treatment may be by online cognitive training. Based on a review of the effectiveness of computer-based cognitive training in healthy elderly, we concluded that cognitive flexibility may be a key element for an effective training, which results in improvements not merely on trained tasks but also in untrained tasks (i.e., far transfer). The aim of the current study was to track the behavioral and neural effects of computer-based cognitive flexibility training after stroke. We expected that executive functioning would improve after the cognitive flexibility training, and that neural activity and connectivity would normalize towards what is seen in healthy elderly. METHODS/DESIGN: The design was a multicenter, double blind, randomized controlled trial (RCT) with three groups: an experimental intervention group, an active control group who did a mock training, and a waiting list control group. Stroke patients (3 months to 5 years post-stroke) with cognitive complaints were included. Training consisted of 58 half-hour sessions spread over 12 weeks. The primary study outcome was objective executive function. Secondary measures were improvement on training tasks, cognitive flexibility, objective cognitive functioning in other domains than the executive domain, subjective cognitive and everyday life functioning, and neural correlates assessed by both structural and resting-state functional Magnetic Resonance Imaging. The three groups were compared at baseline, after six and twelve weeks of training, and four weeks after the end of the training. Furthermore, they were compared to healthy elderly who received the same training. DISCUSSION: The cognitive flexibility training consisted of several factors deemed important for effects that go beyond improvement on merely the training task themselves. Due to the presence of two control groups, the effects of the training could be compared with spontaneous recovery and with the effects of a mock training. This study provides insight into the potential of online cognitive flexibility training after stroke. We also compared its results with the effectiveness of the same training in healthy elderly. TRIAL REGISTRATION: The Netherlands National Trial Register NTR5174. Registered 22 May 2015.

Obstructive Sleep Apnea is Related to Impaired Cognitive and Functional Status after Stroke.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a common sleep disorder in stroke patients and is associated with prolonged hospitalization, decreased functional outcome, and recurrent stroke. Research on the effect of OSA on cognitive functioning following stroke is scarce. The primary objective of this study was to compare stroke patients with and without OSA on cognitive and functional status upon admission to inpatient rehabilitation. DESIGN: Case-control study. SETTING AND PATIENTS: 147 stroke patients admitted to a neurorehabilitation unit. INTERVENTIONS: N/A. MEASUREMENTS: All patients underwent sleep examination for diagnosis of OSA. We assessed cognitive status by neuropsychological examination and functional status by two neurological scales and a measure of functional independence. RESULTS: We included 80 stroke patients with OSA and 67 stroke patients without OSA. OSA patients were older and had a higher body mass index than patients without OSA. OSA patients performed worse on tests of attention, executive functioning, visuoperception, psychomotor ability, and intelligence than those without OSA. No differences were found for vigilance, memory, and language. OSA patients had a worse neurological status, lower functional independence scores, and a longer period of hospitalization in the neurorehabilitation unit than the patients without OSA. OSA status was not associated with stroke type or classification. CONCLUSIONS: Obstructive sleep apnea (OSA) is associated with a lower cognitive and functional status in patients admitted for stroke rehabilitation. This underlines the importance of OSA as a probable prognostic factor, and calls for well-designed randomized controlled trials to study its treatability.

The effect of obstructive sleep apnea and treatment with continuous positive airway pressure on stroke rehabilitation: rationale, design and methods of the TOROS study.

BACKGROUND: Obstructive sleep apnea is a common sleep disorder in stroke patients. Obstructive sleep apnea is associated with stroke severity and poor functional outcome. Continuous positive airway pressure seems to improve functional recovery in stroke rehabilitation. To date, the effect of continuous positive airway pressure on cognitive functioning in stroke patients is not well established. The current study will investigate the effectiveness of continuous positive airway pressure on both cognitive and functional outcomes in stroke patients with obstructive sleep apnea. METHODS/DESIGN: A randomized controlled trial will be conducted on the neurorehabilitation unit of Heliomare, a rehabilitation center in the Netherlands. Seventy stroke patients with obstructive sleep apnea will be randomly allocated to an intervention or control group (n = 2×35). The intervention will consist of four weeks of continuous positive airway pressure treatment. Patients allocated to the control group will receive four weeks of treatment as usual. Outcomes will be assessed at baseline, immediately after the intervention and at two-month follow-up.In a supplementary study, these 70 patients with obstructive sleep apnea will be compared to 70 stroke patients without obstructive sleep apnea with respect to cognitive and functional status at rehabilitation admission. Additionally, the societal participation of both groups will be assessed at six months and one year after inclusion. DISCUSSION: This study will provide novel information on the effects of obstructive sleep apnea and its treatment with continuous positive airway pressure on rehabilitation outcomes after stroke. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR3412.

Can a prediction model combining self-reported symptoms, sociodemographic and clinical features serve as a reliable first screening method for sleep apnea syndrome in patients with stroke?

OBJECTIVE: To determine whether a prediction model combining self-reported symptoms, sociodemographic and clinical parameters could serve as a reliable first screening method in a step-by-step diagnostic approach to sleep apnea syndrome (SAS) in stroke rehabilitation. DESIGN: Retrospective study. SETTING: Rehabilitation center. PARTICIPANTS: Consecutive sample of patients with stroke (N=620) admitted between May 2007 and July 2012. Of these, 533 patients underwent SAS screening. In total, 438 patients met the inclusion and exclusion criteria. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We administered an SAS questionnaire consisting of self-reported symptoms and sociodemographic and clinical parameters. We performed nocturnal oximetry to determine the oxygen desaturation index (ODI). We classified patients with an ODI ≥15 as having a high likelihood of SAS. We built a prediction model using backward multivariate logistic regression and evaluated diagnostic accuracy using receiver operating characteristic analysis. We calculated sensitivity, specificity, and predictive values for different probability cutoffs. RESULTS: Thirty-one percent of patients had a high likelihood of SAS. The prediction model consisted of the following variables: sex, age, body mass index, and self-reported apneas and falling asleep during daytime. The diagnostic accuracy was .76. Using a low probability cutoff (0.1), the model was very sensitive (95%) but not specific (21%). At a high cutoff (0.6), the specificity increased to 97%, but the sensitivity dropped to 24%. A cutoff of 0.3 yielded almost equal sensitivity and specificity of 72% and 69%, respectively. Depending on the cutoff, positive predictive values ranged from 35% to 75%. CONCLUSIONS: The prediction model shows acceptable diagnostic accuracy for a high likelihood of SAS. Therefore, we conclude that the prediction model can serve as a reasonable first screening method in a stepped diagnostic approach to SAS in stroke rehabilitation.

Training memory self-efficacy in the chronic stage after stroke: a randomized controlled trial.

BACKGROUND: Stroke patients with a low memory self-efficacy (MSE) report more memory complaints than patients with a high MSE. OBJECTIVE: The aim of this study was to examine the effect of a memory-training program on MSE in the chronic phase after stroke and to identify which patients benefit most from the MSE training program. METHODS: In a randomized controlled trial, the effectiveness of the MSE training program (experimental group) was compared with a peer support program (control group) in chronic stroke patients. The primary outcome was MSE, measured using the Metamemory-In-Adulthood Questionnaire. Secondary outcomes included depression, quality of life, and objective verbal memory capacity. Changes in outcomes over the intervention period were compared between both groups. Demographic and clinical variables were studied as potential predictors of MSE outcome in the experimental group. RESULTS: In total, 153 patients were included: mean age = 58 years (standard deviation [SD] = 9.7), 54.9% male, and mean of 54 months (SD = 37) after stroke. Of these, 77 were assigned to the training and 76 to the control group. Improvement of MSE (B = 0.40; P = .019) was significantly greater in the training than in the control group. No significant differences were found for the secondary outcomes. An increase in MSE after training was predicted by a younger age (B = -0.033; P = .006) and a better memory capacity (B = 0.043; P = .009), adjusted for baseline MSE. CONCLUSIONS: MSE can be improved by the MSE training program for stroke patients. Younger patients and patients with a better memory capacity benefit most from the MSE training program (Dutch Trial Register: NTR-TC 1656).