None listed
Conditions
Brief summary
The objective of the proposed research is to establish a clinical program to test novel therapeutic interventions for TBI patients with fatigue and/or sleep disturbance. Specifically, the proposed four-year study aims to evaluate, in a randomized controlled trial, the effectiveness of two interventions, cognitive-behavioral therapy (CBT) and light therapy, administered for 8 weeks alone and in combination, in alleviating fatigue, sleep complaints, and cognitive performance following TBI. These innovative interventions will be evaluated in a TBI civilian population, with the aim of translating the program to military populations. Our primary hypotheses are that participants receiving CBT will show reduced self-reported fatigue, reduced daytime sleepiness, and improved sleep (assessed subjectively and objectively) and improved cognitive performance, 4 and 8 weeks after commencement of the CBT program and at one-and six-month follow-up compared to those receiving the current standard of care. In addition, that participants receiving blue light therapy daily will show reduced self-reported fatigue, reduced daytime sleepiness, improved sleep (assessed subjectively and objectively) and improved cognitive performance 4 and 8 weeks after commencement of therapy compared to those receiving the current standard of care. And finally, that patients receiving CBT and blue light therapy (combined) will show greater reductions in self-reported fatigue, reduction in daytime sleepiness, improvement in sleep (assessed subjectively and objectively) and in cognitive performance, after 4 and 8 weeks of the combined treatment and at one- and six-month follow-up compared to those receiving the current standard of care.
Interventions
Light therapy: Light therapy will utilize recent technological advancements in light emitting diodes (LEDs)(GoLite). The light source will consist of an LED array of 276 LEDs mounted behind a plastic lens diffuser, housed within 20 x 24 cm panels (Apollo Light Systems, Orem, Utah). The spectral power distributions of the light source will show a peak at 468nm, confirmed with a spectroradiometer (PR-650 SpectraScan Colorimeter with a CR-650 cosine receptor, Photo Research Inc, Chatsworth CA). Rad
Light therapy: Light therapy will utilize recent technological advancements in light emitting diodes (LEDs)(GoLite). The light source will consist of an LED array of 276 LEDs mounted behind a plastic lens diffuser, housed within 20 x 24 cm panels (Apollo Light Systems, Orem, Utah). The spectral power distributions of the light source will show a peak at 468nm, confirmed with a spectroradiometer (PR-650 SpectraScan Colorimeter with a CR-650 cosine receptor, Photo Research Inc, Chatsworth CA). Radiometric and photometric characteristics of the light source are: 607 µw/cm2, 1.43x1015 photons/cm2/s, 398 lux. Patients assigned to receive light therapy will be instructed to sit directly in front of the light panel (approx. 50 cm distance between eyes and panel) for 45 min each day within 2 hours of wake time. The therapy will continue for 8 weeks. Cognitive behavior therapy (CBT): CBT will include standard CBT procedures for management of depression and anxiety, as well as a focus on regulation of lifestyle within cognitive and physical limitations, regular exercise, training strategies to manage information overload and social difficulties, minimize stress, use of sleep hygiene techniques and pain management. The intervention will be manualized to ensure consistency of approach. However, the emphasis of the sessions will vary according to the specific problems being experienced by the participant. This approach offers a way of individualising empirically validated therapy to meet the needs of individual patients. Flexible, manualized approaches to psychological intervention has been specifically recommended in the literature to deal with the psychological consequences of injury because of the complexity of patient presentations. Following normal CBT practice, homework exercises will be used to consolidate the sessions. The therapy will continue for 8 weeks.
Sponsors
Professor Jennie Ponsford
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
17 Years to 60 Years
Healthy volunteers
No
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.
Outcome results
None listed