Efficacy of Cognitive-Behavioural Therapy for sleep disturbance and fatigue following traumatic brain injury

Monash University0 个研究点目标入组 126 人开始时间: 2017年6月15日最近更新: 2024年4月1日

适应症

试验速览

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•Participants with mild to severe TBI and self-reported sleep disturbance (PSQI greater than 5) and fatigue (FSS or BFI equal or greater than 4), greater than 3 months post-injury. Participants will have a history of blunt head trauma with LOC, initial GCS of 3-14 and/or a period of PTA. They will be aged 17-72 years and have adequate English skills, cognitive ability, visual acuity and physical ability to complete the questionnaires and therapy, as assessed by their treating neuropsychologist.

•Participants will have no history of other neurological disorder, pre-injury sleep disorder or chronic fatigue syndrome requiring treatment. They will have no obesity based on body mass index greater than 31, no transmeridian travel across more than 1 time zone or nightshift work in the preceding 6 weeks, no current use of psychotropic medication, illicit drugs, or medication affecting sleep or causing fatigue, such as benzodiazepines or hypnotics, and no need for surgery during the study period. They will be excluded if screening shows high risk of Obstructive Sleep Apnoea (OSA) which also causes sleep disturbance. They will be permitted to continue whatever medical, psychological or rehabilitative treatment they are receiving, including pharmacological treatment, other than benzodiazepines or hypnotics, provided that the treatment regimen/dose is stable and does not change throughout the study treatment period. The nature of any concurrent therapies will be documented.

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