Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001211459
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
1/09/2016
Date last updated
1/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Cognitive Behavior Therapy for Post-Stroke Fatigue and Sleep Disturbance
Scientific title
Effectiveness of Cognitive Behavior Therapy for Post-Stroke Fatigue and Sleep Disturbance: a Pilot Randomised Controlled Trial
Secondary ID [1] 290069 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 300133 0
Fatigue 300134 0
Sleep disturbance 300135 0
Condition category
Condition code
Stroke 300012 300012 0 0
Ischaemic
Stroke 300013 300013 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 300014 300014 0 0
Other physical medicine / rehabilitation

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 30 min assessment with an exercise physiologist (EP) to establish a baseline of achievable physical activity, aiming for 30 minutes of moderate exercise (walking, exercise bike, swimming) 3-5 times per week, wearing a heart rate monitor. Participants discuss with the EP which physical activities they prefer and the number of sessions that best fit with their current schedules. 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] 295793 0
Rehabilitation
Intervention code [2] 295794 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] 299494 0
Fatigue Severity Scale (FSS)
Timepoint [1] 299494 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [1] 327333 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 327333 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [2] 327336 0
Insomnia Severity Index (ISI)
Timepoint [2] 327336 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [3] 327337 0
Brief Fatigue Inventory (BFI)
Timepoint [3] 327337 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [4] 327338 0
Epworth Sleepiness Scale (ESS)
Timepoint [4] 327338 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment
Secondary outcome [5] 327339 0
Hospital Anxiety Depression Scale (HADS)
Timepoint [5] 327339 0
Baseline, 8 weeks, 16 weeks and 24 weeks from baseline assessment

Eligibility
Key inclusion criteria
Participants aged 17 to 70 years with history of stroke and clinically significant self-reported fatigue (Fatigue Severity Scale [FSS] equal or above 4) and/or poor sleep (Pittsburgh Sleep Quality Index [PSQI] above 5). They need to 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
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are co-morbid neurological disorders, acute psychiatric symptoms or substance abuse, transmeridian travel or night shift work in the previous month and current sleep apnea.

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. Follow-up assessments will be conducted by a research assistant not involved in treatment delivery and masked to group allocation.
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
Random effects regressions will model scores on the primary and secondary measures as functions of treatment and occasion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6587 0
Epworth Richmond - Richmond
Recruitment hospital [2] 6588 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 14194 0
3121 - Richmond
Recruitment postcode(s) [2] 14195 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 294432 0
Other Collaborative groups
Name [1] 294432 0
Moving Ahead Centre of Research Excellence in Brain Recovery
Country [1] 294432 0
Australia
Primary sponsor type
Individual
Name
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] 293285 0
Individual
Name [1] 293285 0
Adam McKay
Address [1] 293285 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 [1] 293285 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295859 0
Epworth Human Research & Ethics Committee
Ethics committee address [1] 295859 0
Ethics committee country [1] 295859 0
Australia
Date submitted for ethics approval [1] 295859 0
13/12/2013
Approval date [1] 295859 0
17/02/2014
Ethics approval number [1] 295859 0
56812

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

Contacts
Principal investigator
Name 68750 0
Prof Jennie Ponsford
Address 68750 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 68750 0
Australia
Phone 68750 0
+61 3 99051552
Fax 68750 0
Email 68750 0
jennie.ponsford@monash.edu
Contact person for public queries
Name 68751 0
Sylvia Nguyen
Address 68751 0
Monash-Epworth Rehabilitation Research Centre
185-187 Hoddle St Richmond VIC 3121
Country 68751 0
Australia
Phone 68751 0
+61 3 94268923
Fax 68751 0
Email 68751 0
sylvia.nguyen@monash.edu
Contact person for scientific queries
Name 68752 0
Jennie Ponsford
Address 68752 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 68752 0
Australia
Phone 68752 0
+61 3 99051552
Fax 68752 0
Email 68752 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
No additional documents have been identified.