Cognitive behavioural therapy for sleep disturbance and fatigue after traumatic brain injury

Not Applicable

• Conditions: Traumatic Brain Injury; Fatigue; Sleep disturbance; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12616001218482
• Lead Sponsor: Professor Jennie Ponsford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI) [Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ]

Secondary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory (BFI)[Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ];Insomnia Severity Index (ISI)[Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ];Fatigue Severity Scale (FSS)[Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ];Epworth Sleepiness Scale (ESS)[Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ];Hospital Anxiety Depression Scale (HADS)[Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ];Short-form 36 (SF-36)[Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment ]