Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000046303
Ethics application status
Not yet submitted
Date submitted
18/01/2008
Date registered
29/01/2008
Date last updated
29/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing Fatigue and Sleep Disturbance Following Traumatic Brain Injury
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue and Sleep disturbance in traumatic brain injury 2713 0
Condition category
Condition code
Injuries and Accidents 2834 2834 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2449 0
Treatment: Devices
Intervention code [2] 2450 0
Lifestyle
Intervention code [3] 2451 0
Rehabilitation
Comparator / control treatment
Treatment as usual: In this control condition, participants will continue to receive whatever medical, rehabilitative or psychological interventions they might otherwise be receiving, the nature of which will be carefully documented for these and all study participants. They will have no additional intervention.
Control group
Active

Outcomes
Primary outcome [1] 3717 0
Fatigue Severity Scale (FSS): This will be used as a primary outcome measure. It is a 9-item general fatigue scale that assesses the behavioral consequences, rather than the symptoms of fatigue and the impact of fatigue on daily functioning. The FSS has acceptable internal consistency, stability over time, sensitivity to clinical changes and the ability to distinguish between brain injured patients from controls.
Timepoint [1] 3717 0
The FSS will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Primary outcome [2] 3718 0
Visual Analogue Scale for Fatigue (VAS-F).This is 18-item measure that requires the participant to circle a number between 1 and 10 on a continuum of fatigue or energy/vigour. The scale contains a fatigue subscale and a vigour subscale. Research has shown this scale to be a reliable and valid measure of fatigue. We have found the scale to be sensitive to change in subjective fatigue in TBI individuals over time.
Timepoint [2] 3718 0
The VAS-F will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Primary outcome [3] 3719 0
Causes of Fatigue Questionnaire (COF). This 12-item scale was constructed as a 5-point likert scale measure of the extent to which a number of specific activities cause fatigue. Activities include tasks that are primarily physical (eg. exercising, going for walk), tasks that are primarily mental (eg. reading, having a conversation) and tasks that are less easily categorized as physical or mental (eg. shopping, participating in social activities). Responses are scored 1-5, with 1 representing ?Never True? and 5 representing ?Always True?.
Timepoint [3] 3719 0
The COF will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Secondary outcome [1] 6269 0
The Epworth Sleepiness Scale (ESS). This daytime sleepiness measure is widely used as an index of sleep propensity in adults. Participants rate how likely they would be to doze off in eight situations, in their usual way of life, on a scale from 0 (would never doze) to 3 (high chance of dozing). Total score range 0-24.
Timepoint [1] 6269 0
The ESS will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Secondary outcome [2] 6270 0
Pittsburgh Sleep Quality Index(PSQI): This instrument is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month period. Seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score are generated from 19 questions. The global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p< .001) in distinguishing good and poor sleepers.
Timepoint [2] 6270 0
The PSQI will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Secondary outcome [3] 6271 0
Complex Selective Attention Task (C-SAT). This task assesses reaction time and selective attention under conditions of high working memory load. Letters and numbers in pink and blue, are sequentially displayed on a monitor. Participants respond by the left button if a pink letter or blue number appears and the right button if a blue letter or pink number appears. Measures include RT, recorded in milliseconds and errors.
Timepoint [3] 6271 0
The C-SAT will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Secondary outcome [4] 6272 0
Hospital Anxiety and Depression Scale (HADS): This is a 14-item self-report questionnaire for assessing anxiety and depression. It is relatively unaffected by concurrent physical illness and has been used in both hospital and community settings. It has been used in TBI follow-up studies and has demonstrated sensitivity to anxiety and depression in TBI individuals [189]. Scores range from 0-21, with scores from 0-7 representing a ?normal?, 8-10 a ?mild?, 11-14 a ?moderate? and 15-21 a ?severe? level of anxiety or depression.
Timepoint [4] 6272 0
The HADS will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Secondary outcome [5] 6273 0
Actigraphic sleep parameters. Actiwatch-L (Respironics, USA) is a wrist actigraph (16g) with an integrated light sensor (range 0.1 to 150,000 lux). Several parameters can be derived from actigraphic data, including sleep duration, sleep efficiency (total sleep time divided by time in bed), number of awakenings.
Timepoint [5] 6273 0
Participants will be instructed to wear the actigraph day and night (avoiding immersion in water) during the 4 week baseline period and during the 8 week intervention period.
Secondary outcome [6] 6274 0
The Sydney Psychosocial Reintegration Scale (SPRS) (Form A) will measure functional outcome from the perspective of the injured person and a significant other. It has patient and relative versions and measures change from pre-injury functioning in 3 domains: occupational activity, interpersonal relationships and independent living skills. Items are rated on a 7-point scale ranging from 0 (extreme change) to 6 (no change), giving a total subscale score (0-24) and total overall score (0-72). The SPRS has been shown to have high levels of internal consistency, with Cronbach?s alpha ranging from .69 to.89 and good inter-rater reliability.
Timepoint [6] 6274 0
The SPRS will be administered at times (1) on recruitment, (4), on completion of intervention and (6) at six-month follow-up
Secondary outcome [7] 6275 0
SF-36 Health Survey (SF-36). This measures the impact of the injury on the individual?s lifestyle from the perspective of the injured person. The SF-36 has 36 items, yielding an 8-scale health profile and summary measures of health-related quality of life. The SF-36 has been documented in more than 750 publications and has proven useful in differentiating the health benefits produced by different treatments.
Timepoint [7] 6275 0
The SPRS will be administered at times (1) on recruitment, (4), on completion of intervention and (6) at six-month follow-up
Secondary outcome [8] 6276 0
Beck Depression Inventory (BDI). The BDI is a 21-item self-report instrument of depression that assesses symptoms over a 7 day period. It has a 4 point scale for each item ranging from 0-3. Total scores range from 0-63. It has a high internal consistency, high content validity, high validity in differentiating between depressed and non-depressed subjects, sensitivity to change and has a high international propagation.
Timepoint [8] 6276 0
The BDI will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.
Secondary outcome [9] 6277 0
Brief Pain Inventory (BPI). This will be used to assess the severity of pain and impact of pain on daily functions. It comprises four items measuring intensity of pain and seven items measuring interference of pain in the patient?s life on a 10-point scale. It has demonstrated reliability and validity across cultures and languages and with a variety of non-cancer-related pain conditions.
Timepoint [9] 6277 0
The BPI will be taken on a total of six occasions, (1) Week 1 on enrolment (2) Week 4, prior to commencing therapy, (3) Week 8, midway through the 8-week therapy block (4) Week 12, on completion of therapy; (5) Week 16 four weeks post-therapy; (6) 6 months post-completion of therapy.

Eligibility
Key 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.
Minimum age
17 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be a randomized controlled trial evaluating the effectiveness of two interventions, namely CBT and light therapy using a light in the short wavelength (or blue) range, both alone and in combination, in alleviating self-reported fatigue, sleepiness and sleep disturbance/sleepiness following TBI. The study will have four parallel groups. Following baseline assessment, patients will be randomized to one of the following groups for 8 weeks of treatment: 1) 35 participants in the CBT group only; 2) 35 participants in the blue light only; 3) 35 participants in the CBT + blue light; 4) 35 participants in the treatment as usual (control) group. All patients satisfying selection criteria will be contacted by a non-treating staff recruiter, screened further and invited to participate in the research project. The nature of treatment received by each participant will be assigned randomly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur on completion of the initial assessment. Randomization will be computer generated using a program specifically designed for this purpose. An independent person will make a series of cards with the randomized group, sealed in envelopes and marked in order. This system has advantages over a phone-in or other system as it is portable and does not require access to phone or the cost of a full-time person to access the randomization schedule
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 734 0
3121
Recruitment postcode(s) [2] 735 0
3181

Funding & Sponsors
Funding source category [1] 2985 0
Other
Name [1] 2985 0
US Army Medical Research and Materiel Command - Department of Defense
Country [1] 2985 0
United States of America
Funding source category [2] 2986 0
Other
Name [2] 2986 0
US Army Medical Research and Materiel Command
Country [2] 2986 0
United States of America
Primary sponsor type
Individual
Name
Professor Jennie Ponsford
Address
Monash University, School of Psychology, Psychiatry and Psychological Medicine, Building 17, Clayton Campus, Monash University
Country
Australia
Secondary sponsor category [1] 2694 0
Individual
Name [1] 2694 0
Dr. Shantha Rajaratnum
Address [1] 2694 0
Monash University, School of Psychology, Psychiatry and Psychological Medicine, Building 17, Clayton Campus, Monash University.
Country [1] 2694 0
Australia
Secondary sponsor category [2] 2695 0
Individual
Name [2] 2695 0
Dr. Steven Lockley
Address [2] 2695 0
Division of Sleep Medicine
Brigham and Womens Hospital; Harvard Medical School; Warwick Medical School.
Country [2] 2695 0
United Kingdom
Other collaborator category [1] 159 0
Individual
Name [1] 159 0
Professor Jeffrey Rosenfeld
Address [1] 159 0
National Trauma Research Institute, The Alfred, PO Box 315, Prahran, VIC 3181
Country [1] 159 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4941 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 4941 0
Ethics committee country [1] 4941 0
Australia
Date submitted for ethics approval [1] 4941 0
06/02/2008
Approval date [1] 4941 0
28/02/2008
Ethics approval number [1] 4941 0
Ethics committee name [2] 4942 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [2] 4942 0
Ethics committee country [2] 4942 0
Australia
Date submitted for ethics approval [2] 4942 0
06/02/2008
Approval date [2] 4942 0
28/02/2008
Ethics approval number [2] 4942 0
Ethics committee name [3] 4943 0
Epworth Healthcare Human Research Ethics Committee
Ethics committee address [3] 4943 0
Ethics committee country [3] 4943 0
Australia
Date submitted for ethics approval [3] 4943 0
06/02/2008
Approval date [3] 4943 0
28/03/2008
Ethics approval number [3] 4943 0
Ethics committee name [4] 4944 0
Ethics committee address [4] 4944 0
Ethics committee country [4] 4944 0
Date submitted for ethics approval [4] 4944 0
06/02/2008
Approval date [4] 4944 0
Ethics approval number [4] 4944 0
Ethics committee name [5] 4945 0
The Alfred Research Ethics Committee
Ethics committee address [5] 4945 0
Ethics committee country [5] 4945 0
Australia
Date submitted for ethics approval [5] 4945 0
06/02/2008
Approval date [5] 4945 0
28/02/2008
Ethics approval number [5] 4945 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28298 0
Address 28298 0
Country 28298 0
Phone 28298 0
Fax 28298 0
Email 28298 0
Contact person for public queries
Name 11455 0
Monique Roper
Address 11455 0
Epworth Hospital
Monash-Epworth Rehabilitation Research Centre, 29 Erin Street, Richmond, 3121.
Country 11455 0
Australia
Phone 11455 0
61 03 9426 8747
Fax 11455 0
Email 11455 0
[email protected]
Contact person for scientific queries
Name 2383 0
Professor Jennie Ponsford
Address 2383 0
Monash University, School of Psychology, Psychiatry and Psychological Medicine, Building 17, Clayton Campus, Monash University
Country 2383 0
Australia
Phone 2383 0
61 03 9426 8747
Fax 2383 0
Email 2383 0
[email protected]

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No Supporting Document Provided



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