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

Abstract 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 weeks 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 Register: Netherlands Trial Register, NTR7082, 12 March 2018

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

Trials ◽

10.1186/s13063-020-04789-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Marthe E. Ford ◽

Gert J. Geurtsen ◽

Erny Groet ◽

Coen A. M. Van Bennekom ◽

Eus J. W. Van Someren

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Cognitive Behavioral Therapy ◽

Cognitive Functioning ◽

Behavioral Therapy ◽

Acquired Brain Injury ◽

Cognitive Behavioral ◽

Secondary Outcome ◽

Face To Face ◽

Insomnia Severity

Abstract 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.

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Treatments for sleep disturbances in individuals with acquired brain injury: A systematic review

Clinical Rehabilitation ◽

10.1177/02692155211014827 ◽

2021 ◽

pp. 026921552110148

Author(s):

Louise Pilon ◽

Nikita Frankenmolen ◽

Dirk Bertens

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Cognitive Behavioral Therapy ◽

Sleep Disturbances ◽

Behavioral Therapy ◽

Experimental Studies ◽

Acquired Brain Injury ◽

Cognitive Behavioral ◽

Study Quality ◽

Severe Acquired Brain Injury

Objective: To systematically review the evidence on the treatments of sleep disturbances in individuals with acquired brain injury. Data sources: PubMed, Embase, Web of Science, and PsycINFO were searched from inception to January 2021. Review method: Eligibility criteria were (1) participants with mild to severe acquired brain injury from traumatic brain injury and stroke (⩾three months post-injury), (2) individuals aged 16 years and older, (3) participants with self-reported sleep disturbances, (4) controlled group studies and single case (experimental) studies, and (5) interventions aimed at treatment of sleep disturbances. Two researchers independently identified relevant studies and assessed their study quality using the revised Cochrane assessment of bias tool (RoB 2.0) and the risk-of-bias in N-of-1 trials (RoBiNT) scale. Results: The search yielded 655 records; 11 studies met the inclusion criteria and were included, with a total of 227 participants (207 individuals with traumatic brain injury, 20 stroke patients). Two studies included pharmacological therapy, six studies examined the effects of cognitive behavioral therapy and three studies investigated alternative interventions such as acupuncture. Conclusion: Although there was heterogeneity in the study quality of the included studies, their outcomes suggest that cognitive behavioral therapy is recommended as treatment of choice for improving sleep in individuals with acquired brain injury, especially for patients with mild to severe traumatic brain injury. Future research should examine the effects of cognitive behavioral therapy in more high-quality randomized controlled designs.

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