Efficacy of cognitive behavioural therapy to treat sleep disturbance and fatigue following traumatic brain injury: a randomised controlled trial

Professor Jennie Ponsford0 sites126 target enrollmentSeptember 2, 2016

Overview

No summary available.

Registry

who.int

Start Date

September 2, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Professor Jennie Ponsford

•Participants with mild to severe TBI and self\-reported sleep disturbance (PSQI greater than 5 and/or fatigue (FSS or BFI equal or greater than 4\), recruited via Epworth Hospital after return to the community. 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\-65 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 and live within a one\-hour radius of the hospital.

•They will have no history of other neurological disorder, no transmeridian travel across \>1 time zone or nightshift work in the preceding 4 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, EDS and mood changes. 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.