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

Autor: Gert J. Geurtsen, Eus J.W. Van Someren, Marthe E. Ford, Erny Groet, Coen A M van Bennekom
Přispěvatelé: Integrative Neurophysiology, Amsterdam Neuroscience - Mood, Anxiety, Psychosis, Stress & Sleep, Medical Psychology, Coronel Institute of Occupational Health, APH - Mental Health, Netherlands Institute for Neuroscience (NIN), Psychiatry
Jazyk: angličtina
Rok vydání: 2020
Předmět:
030506 rehabilitation
medicine.medical_treatment
Medicine (miscellaneous)
law.invention
Study Protocol
0302 clinical medicine
Traumatic brain injury
Randomized controlled trial
law
Sleep Initiation and Maintenance Disorders
Multicenter Studies as Topic
Pharmacology (medical)
Prospective Studies
Netherlands
Randomized Controlled Trials as Topic
education.field_of_study
lcsh:R5-920
Telemedicine
Cognitive behavioral therapy
Stroke
Treatment Outcome
Online treatment
Acquired brain injury
Anxiety
Sleep diary
medicine.symptom
0305 other medical science
lcsh:Medicine (General)
medicine.medical_specialty
Insomnia
Population
Cognitive behavioral therapy for insomnia
03 medical and health sciences
SDG 3 - Good Health and Well-being
mental disorders
medicine
Humans
education
business.industry
medicine.disease
Brain Injuries
Quality of Life
Physical therapy
eHealth
business
Sleep
030217 neurology & neurosurgery
Zdroj: Trials, Vol 21, Iss 1, Pp 1-8 (2020)
Trials, 21:861, 1-8. BioMed Central
Ford, M E, Geurtsen, G J, Groet, E, Van Bennekom, C A M & Van Someren, E J W 2020, ' A blended eHealth intervention for insomnia following acquired brain injury : study protocol for a randomized controlled trial ', Trials, vol. 21, no. 1, 861 . https://doi.org/10.1186/s13063-020-04789-y
Trials, 21(1):861. BioMed Central
Ford, M E, Geurtsen, G J, Groet, E, Van Bennekom, C A M & Van Someren, E J W 2020, ' A blended eHealth intervention for insomnia following acquired brain injury : study protocol for a randomized controlled trial ', Trials, vol. 21, 861, pp. 1-8 . https://doi.org/10.1186/s13063-020-04789-y
Trials, 21(1). BioMed Central
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04789-y
Popis: 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.
Databáze: OpenAIRE
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