ACTRN12608000046303Not yet recruitingPhase 2
Evaluating the effects of cognitive behavioural therapy and light therapy compared to treatment as usual on fatigue and sleep disturbance in people with traumatic brain injury
Professor Jennie Ponsford0 sites140 target enrollmentStarted: January 29, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 17 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •Participants will have sustained a mild, moderate or severe traumatic brian injury; they will be between 17 and 60 years of age and have adequate English skills, cognitive ability, visual acuity and physical ability to complete the questionnaires and therapy tasks.
Exclusion Criteria
- •They will have no history of previous head injury, neurological disorder, pre-injury sleep disorder or chronic fatigue syndrome, which has required treatment. Those with pre-injury psychiatric disorders or substance abuse requiring hospitalisation will also be exlcuded. They will be excluded if they need to undergo any surgery during the period of the study. They will have no obesity based on body mass index, have had no transmeridian travel across more than one time zone in the preceding 3 months, no nightshift work in the preceding 3 months, no current use of psychotropic medication and no illicit drug use. Participants will be exlcuded if they have experienced epileptic seizures following injury or are tkaing medication known to have a significant effect upon sleep or cause fatigue, such as benzodiazepines.
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