Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000878370
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
15/06/2017
Date last updated
24/03/2024
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
20/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive-Behavioural Therapy for sleep disturbance and fatigue following traumatic brain injury
Scientific title
Efficacy of Cognitive-Behavioural Therapy for sleep disturbance and fatigue following traumatic brain injury
Secondary ID [1] 291943 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12616001218482

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 303283 0
Sleep disturbance 303284 0
Fatigue 303285 0
Condition category
Condition code
Neurological 302713 302713 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 302714 302714 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive-Behavioural Therapy for sleep and fatigue (CBT-SF): CBT-SF will consist of 8 one hour sessions conducted weekly, either in-person or via tele-health using Zoom, focused on reducing and preventing sleep disturbance and fatigue. Sleep is addressed in sessions 1, 2, 5, 6 and 8 and fatigue in sessions 1, 2, 3, 4, 7 and 8. Session 1 will include psycho-education about post-TBI sleep disturbance and fatigue, including how poor sleep habits relate to fatigue. Self monitoring of daily activities and subjective fatigue levels will be initiated to encourage understanding of the link between activity levels and fatigue. Participants will be encouraged to engage in regular cardiovascular exercise as a form of behavioural activation. In session 2, the self-monitoring diary will be reviewed to encourage participants to regulate their activity schedule to balance rest and activity and sleep hygiene practices promoted. Traditional CBTi elements including stimulus control and sleep restriction are introduced, monitored through sleep diaries and reinforced in subsequent sessions. Sessions 3 and 4 will focus on gradually increasing or decreasing activity levels depending on goals. Cognitive therapy is used to address maladaptive thoughts underpinning behaviours that reinforce fatigue and disturbed sleep patterns. Session 5 will provide sleep education, including sleep need, sleep stages, circadian rhythms, homeostatic pressure, model of insomnia and include detailed discussion of sleep restriction, stimulus control and sleep hygiene recommendations and how these can be implemented for the participant. Adherence to new bedtime schedules and better sleep practices is reviewed at subsequent sessions. Cognitive interventions for insomnia (cognitive restructuring, imagery and visualisation) and behavioural interventions for insomnia (stimulus control, sleep restriction, constructive worry sheet and progressive muscle relaxation) will be addressed in Session 6. In Session 7 the focus will be on practical strategies to manage information overload and minimize physical and mental fatigue. The last session will promote long-term gains by reviewing therapeutic techniques, troubleshooting lingering concerns and establishing relapse prevention plans. The intervention has been manualized to ensure consistency of approach.
Participants will continue whatever medical, psychological or rehabilitative interventions they are otherwise receiving. The therapy will be individual and carried out face-to-face by Clinical Psychologists/Neuropsychologists with experience in CBT and understanding of TBI. They will be supervised by a psychologist expert in CBTi (Moira Junge). 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.
Intervention code [1] 298066 0
Rehabilitation
Intervention code [2] 298224 0
Treatment: Other
Comparator / control treatment
Health education control condition (HE): Controls will receive 8 weekly one-hour sessions providing information about brain injury, healthy lifestyle, sleep and fatigue. This will control for non-specific therapy factors and the focus on sleep and fatigue in the active intervention. Topics will include education about brain injury, fatigue, sleep, exercise, diet, alcohol, drugs, cognitive difficulties after TBI and recovery from TBI, with no guided practice or feedback. Activity pacing, sleep restriction and stimulus control principles will be strictly avoided.
Participants will continue whatever medical, psychological or rehabilitative interventions they are otherwise receiving.
The therapy will be carried out by Clinical Psychologists/Neuropsychologists with understanding of TBI and the therapy will be manualised for consistency. It will be conducted face-to-face in the same number of individual sessions as the active treatment. 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.
Control group
Active

Outcomes
Primary outcome [1] 302110 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 302110 0
16 weeks from baseline assessment
Secondary outcome [1] 334813 0
Brief Fatigue Inventory (BFI)
Timepoint [1] 334813 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [2] 334814 0
Insomnia Severity Index (ISI)
Timepoint [2] 334814 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [3] 334816 0
Fatigue Severity Scale (FSS)
Timepoint [3] 334816 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [4] 334817 0
Epworth Sleepiness Scale (ESS)
Timepoint [4] 334817 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [5] 334819 0
Mean sleep efficiency (percentage of sleep time/time sleep in bed) based on actigraphy and supported by self-report sleep diaries.
Timepoint [5] 334819 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [6] 334821 0
Sleep onset latency based on actigraphy
Timepoint [6] 334821 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [7] 334824 0
Percentage of time spent in productive activity from self report activity diaries. Productive activity is defined as any meaningful activity including paid or unpaid employment or study, sporting, recreational or social activities, family participation, or personal, domestic, or community activities of daily living, but not including resting activities.
Timepoint [7] 334824 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [8] 334825 0
Self efficacy scale scores
Timepoint [8] 334825 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [9] 334826 0
Hospital Anxiety and Depression Scale (HADS) depression scores
Timepoint [9] 334826 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [10] 334828 0
SF-36v2 Health Survey (SF-36v2)
Timepoint [10] 334828 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [11] 343931 0
Health Service Utilisation assessed by collecting quantity of visits/number of times accessed for a range of health services by each participant. These health services include: medication, physiotherapy, occupational therapy, psychology, GP, paid care, unpaid care, community or social care services and hospital admissions.
Timepoint [11] 343931 0
8, 16 and 24 weeks post baseline.

Eligibility
Key inclusion criteria
Participants with mild to severe TBI and self-reported sleep disturbance (PSQI greater than 5) and fatigue (FSS or BFI equal or greater than 4), greater than 3 months post-injury. 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 17-72 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.
Minimum age
17 Years
Maximum age
72 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will have no history of other neurological disorder, pre-injury sleep disorder or chronic fatigue syndrome requiring treatment. They will have no obesity based on body mass index greater than 31, no transmeridian travel across more than 1 time zone or nightshift work in the preceding 6 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. 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. The nature of any concurrent therapies will be documented.

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 length permuted blocks algorithm, {G, 2013 #61} 59 stratified according to median baseline sleep disturbance to ensure levels are matched across conditions. A ratio of 2:1 for CBT:Control will be utilised.
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
Regression methods appropriate for the analysis of repeated measures data, such as random effects / mixed-model regression or generalized estimating equations, 64,65 incorporating generalized models for non-normal data as needed, will be used to model PSQI scores as functions of treatment (CBT-SF vs control) and time point, controlling for baseline sleep disturbance and fatigue.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2017
Actual
30/06/2017
Date of last participant enrolment
Anticipated
Actual
4/10/2022
Date of last data collection
Anticipated
31/10/2023
Actual
18/10/2023
Sample size
Target
126
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296455 0
Government body
Name [1] 296455 0
National Health and Medical Research Council
Country [1] 296455 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 295411 0
Hospital
Name [1] 295411 0
Epworth Health Care
Address [1] 295411 0
89 Bridge Rd
Richmond VIC 3121
Country [1] 295411 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297680 0
Epworth Human Research Ethics Committee
Ethics committee address [1] 297680 0
Epworth Hospital
89 Bridge Rd
Richmond VIC 3121
Ethics committee country [1] 297680 0
Australia
Date submitted for ethics approval [1] 297680 0
Approval date [1] 297680 0
11/05/2017
Ethics approval number [1] 297680 0
568-12

Summary
Brief summary
Sleepiness and fatigue are frequent debilitating problems following traumatic brain injury (TBI). Medications have not provided long-term solutions for these symptoms and there is little research into psychological treatments. Cognitive Behaviour Therapy (CBT) is a well-established treatment for insomnia and chronic fatigue in those without a brain injury. The Monash-Epworth Rehabilitation Research Centre is conducting a world first study to investigate whether CBT can be effectively adapted to reduce symptoms of fatigue and sleep disturbance after TBI. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with another group of participants receiving 8 sessions of health education for issues specifically related to TBI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74798 0
Prof Jennie Ponsford
Address 74798 0
Monash University
Wellington Rd
Clayton VIC 3800
Country 74798 0
Australia
Phone 74798 0
+61 3 990 51552
Fax 74798 0
Email 74798 0
Jennie.Ponsford@monash.edu
Contact person for public queries
Name 74799 0
Prof Jennie Ponsford
Address 74799 0
Monash University
Wellington Rd
Clayton VIC 3800
Country 74799 0
Australia
Phone 74799 0
+61 3 990 51552
Fax 74799 0
Email 74799 0
Jennie.Ponsford@monash.edu
Contact person for scientific queries
Name 74800 0
Prof Jennie Ponsford
Address 74800 0
Monash University
Wellington Rd
Clayton VIC 3800
Country 74800 0
Australia
Phone 74800 0
+61 3 990 51552
Fax 74800 0
Email 74800 0
Jennie.Ponsford@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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 Behavioral Therapy for Sleep Disturbance and Fatigue Following Acquired Brain Injury: Predictors of Treatment Response.2022https://dx.doi.org/10.1097/HTR.0000000000000705
N.B. These documents automatically identified may not have been verified by the study sponsor.