Managing Fatigue and Sleep Disturbance Following Traumatic Brain Injury
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 Ponsford
140 participants
Sep 1, 2008
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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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). 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.
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ACTRN12608000046303