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Trial registered on ANZCTR


Registration number
ACTRN12616001218482
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
2/09/2016
Date last updated
30/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive behavioural therapy for sleep disturbance and fatigue after traumatic brain injury
Scientific title
Efficacy of cognitive behavioural therapy to treat sleep disturbance and fatigue following traumatic brain injury: a randomised controlled trial
Secondary ID [1] 290045 0
None
Universal Trial Number (UTN)
U1111-1187-0145
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 300094 0
Fatigue 300095 0
Sleep disturbance 300096 0
Condition category
Condition code
Neurological 299981 299981 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 299982 299982 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 300003 300003 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of 8 one-hour individual sessions of Cognitive Behavioural Therapy (CBT) conducted weekly, focused on reducing and preventing sleep disturbance and fatigue. The therapists are Clinical Neuropsychologists with doctoral qualifications, advanced training in CBT and experience working with a brain-injured cohort. Treatment is delivered according to a standardised treatment manual developed specifically for the study and adapted for cognitive impairments common to brain injury. Treatment fidelity and adherence to protocol will be assessed by audio taping all sessions; a random sample of 10% of sessions will be rated by an independent assessor expert in CBT. They will be supervised by a psychologist expert in CBT-i (CBT for insomnia) to maintain and improve fidelity. Therapy sessions are to be conducted at clinic rooms at Epworth Richmond, Monash Clayton or at the participant's home. Participants will be also encouraged to engage in regular cardiovascular exercise in their target heart range (i.e. 60-80% of their maximum heart rate) to enhance their aerobic fitness and as a form of behavioural activation. They have a one-off assessment with an exercise physiologist (EP) between the 1st and 3rd therapy session (when behaviour activation is addressed). Participants discuss with the EP which physical activities they prefer (e.g walking, exercise bike, swimming) and the number of sessions that best fit with their current schedules but generally participants will be instructed to aim for 30 minutes of moderate exercise 3-5 times per week for 8 weeks, wearing a heart rate monitor to ensure they achieve their target heart rate range. Participants will undergo a repeat assessment post-treatment to determine if there are any changes in cardiovascular fitness. A step count pedometer is provided at each follow up as a basic measure of level of average physical activity across the week. This also provides an indication of adherence to exercise guidelines.
Intervention code [1] 295769 0
Rehabilitation
Intervention code [2] 295789 0
Treatment: Other
Comparator / control treatment
The control condition is treatment as usual (TAU) and control participants will continue whatever standard medical, psychological or rehabilitative interventions they are otherwise receiving, the nature of which will be documented for all study participants.
Control group
Active

Outcomes
Primary outcome [1] 299463 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 299463 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [1] 327254 0
Brief Fatigue Inventory (BFI)
Timepoint [1] 327254 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [2] 327255 0
Insomnia Severity Index (ISI)
Timepoint [2] 327255 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [3] 327256 0
Fatigue Severity Scale (FSS)
Timepoint [3] 327256 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [4] 327257 0
Epworth Sleepiness Scale (ESS)
Timepoint [4] 327257 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [5] 327258 0
Hospital Anxiety Depression Scale (HADS)
Timepoint [5] 327258 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [6] 327259 0
Short-form 36 (SF-36)
Timepoint [6] 327259 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment

Eligibility
Key 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.
Minimum age
17 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization schedules will be generated by a statistician, independent of both the study and data analysis, who will notify the study co-ordinator of the participant’s treatment condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified randomization will be adopted using a random permuted blocks within strata algorithm stratified according to baseline sleep disturbance and fatigue to ensure levels are matched across conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be conducted. Primary outcome will be the global PSQI score. Secondary outcomes will be (1) BFI fatigue, (2) ISI scores, (3) FSS fatigue (4) ESS scores, (5) HADS depression scores, and (6) SF-36 quality of life scores. Random effects
regression will be performed to model PSQI scores as functions of treatment (CBT vs control) and time point controlling for baseline symptoms. This approach will also be used to model the above-mentioned secondary outcome variables. Power calculations were not performed because the estimates from this pilot study will be used to determine adequate sample size for a larger phase III trial.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
31/12/2018
Actual
16/11/2016
Date of last data collection
Anticipated
31/08/2019
Actual
11/08/2017
Sample size
Target
126
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6559 0
Epworth Richmond - Richmond
Recruitment hospital [2] 6560 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 14157 0
3121 - Richmond
Recruitment postcode(s) [2] 14158 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 294414 0
Hospital
Name [1] 294414 0
Epworth Research Institute
Country [1] 294414 0
Australia
Funding source category [2] 294418 0
Other Collaborative groups
Name [2] 294418 0
Moving Ahead CRE in Brain Recovery
Country [2] 294418 0
Australia
Primary sponsor type
Individual
Name
Professor Jennie Ponsford
Address
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 293264 0
None
Name [1] 293264 0
Address [1] 293264 0
Country [1] 293264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295833 0
Epworth Human Research & Ethics Committee
Ethics committee address [1] 295833 0
Ethics committee country [1] 295833 0
Australia
Date submitted for ethics approval [1] 295833 0
06/09/2012
Approval date [1] 295833 0
24/10/2012
Ethics approval number [1] 295833 0
56812

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

Contacts
Principal investigator
Name 68678 0
Prof Jennie Ponsford
Address 68678 0
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria, Australia
Country 68678 0
Australia
Phone 68678 0
+61 3 99051552
Fax 68678 0
+61 3 99053948
Email 68678 0
jennie.ponsford@monash.edu
Contact person for public queries
Name 68679 0
Sylvia Nguyen
Address 68679 0
Monash-Epworth Rehabilitation Research Centre
185-187 Hoddle St Richmond VIC 3121
Country 68679 0
Australia
Phone 68679 0
+61 3 94268923
Fax 68679 0
Email 68679 0
sylvia.nguyen@monash.edu
Contact person for scientific queries
Name 68680 0
Jennie Ponsford
Address 68680 0
School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria, Australia
Country 68680 0
Australia
Phone 68680 0
+61 3 99051552
Fax 68680 0
+61 3 99053948
Email 68680 0
jennie.ponsford@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCognitive Behavior Therapy to Treat Sleep Disturbance and Fatigue After Traumatic Brain Injury: A Pilot Randomized Controlled Trial.2017https://dx.doi.org/10.1016/j.apmr.2017.02.031
N.B. These documents automatically identified may not have been verified by the study sponsor.