Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000286549
Ethics application status
Approved
Date submitted
20/02/2024
Date registered
20/03/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of using Cognitive Behavioural Therapy for Insomnia to improve athlete sleep quality: A sleep intervention study
Scientific title
Efficacy of using Cognitive Behavioural Therapy for Insomnia to improve sleep quality in healthy athletes: A sleep intervention study
Secondary ID [1] 311573 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 332946 0
Sleep quantity 332947 0
Athlete-specific psychological stress 332948 0
Condition category
Condition code
Mental Health 329661 329661 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 329818 329818 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our study will involve one participant group of athletes who will all be exposed to the sleep intervention. The group size will be approximately twenty (20) healthy athletes. Our sleep intervention is a Cognitive Behavioural Therapy for Insomnia (CBT-I) protocol that has been developed for use with athletes. The CBT-I intervention will be administered via 5 x 30 min weekly group sessions and will be conducted by an endorsed Sport Psychologist who has professional training in CBT-I (Harley de Vos). The CBT-I intervention will include sleep education, environmental factors, sleep behaviours, cognitive strategies, and relaxation techniques.
To monitor adherence to the intervention, a session attendance checklist will be completed before each session of the CBT-I intervention is administered.
Intervention code [1] 328025 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337448 0
Sleep quality
Timepoint [1] 337448 0
Baseline, post-completion of intervention (primary endpoint), and two-month follow-up post-intervention
Secondary outcome [1] 431900 0
Sleep duration
Timepoint [1] 431900 0
Baseline, post-completion of intervention, two-month follow-up post-intervention.
Secondary outcome [2] 431901 0
Sleep behaviours
Timepoint [2] 431901 0
Baseline, post-completion of intervention, two-month follow-up post-intervention.
Secondary outcome [3] 431902 0
Daytime Sleepiness
Timepoint [3] 431902 0
Baseline, post-completion of intervention, and two-month follow-up post-intervention.
Secondary outcome [4] 431903 0
Athlete-specific psychological distress
Timepoint [4] 431903 0
Baseline, post-completion of intervention, and two-month follow-up post-intervention.

Eligibility
Key inclusion criteria
At least 16 years of age; AND
A student athlete competing for a sporting club within Sydney Uni Sport and Fitness;
OR
An athlete, including a high-school athlete, currently competing at the pre-elite or elite stages of the talent pathway identified by their National Sporting Organisation, National Institute Network or National Basketball Association Global Academy based at the Australian Institute of Sport.
Fluent in English
Willingness to give written informed consent prior to participation in the study
Willingness to comply with the study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently pregnant
Suffering chronic or complex pain
Suffers from a cognitive impairment, Autism-Spectrum Disorder, or other neurological disorder
Not fluent in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/09/2024
Actual
5/09/2024
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
20
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 315872 0
University
Name [1] 315872 0
The University of Sydney
Country [1] 315872 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318012 0
None
Name [1] 318012 0
Address [1] 318012 0
Country [1] 318012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314720 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314720 0
Ethics committee country [1] 314720 0
Australia
Date submitted for ethics approval [1] 314720 0
23/01/2024
Approval date [1] 314720 0
07/06/2024
Ethics approval number [1] 314720 0
2024/HE000041

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

Contacts
Principal investigator
Name 132514 0
A/Prof Suzi Edwards
Address 132514 0
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science Central Sydney (Patyegarang) Precinct Susan Wakil Health Building D18 | The University of Sydney | NSW | 2006
Country 132514 0
Australia
Phone 132514 0
+61 2 8627 7895
Fax 132514 0
Email 132514 0
[email protected]
Contact person for public queries
Name 132515 0
Suzi Edwards
Address 132515 0
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science Central Sydney (Patyegarang) Precinct Susan Wakil Health Building D18 | The University of Sydney | NSW | 2006
Country 132515 0
Australia
Phone 132515 0
+61 2 8627 7895
Fax 132515 0
Email 132515 0
[email protected]
Contact person for scientific queries
Name 132516 0
Suzi Edwards
Address 132516 0
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science Central Sydney (Patyegarang) Precinct Susan Wakil Health Building D18 | The University of Sydney | NSW | 2006
Country 132516 0
Australia
Phone 132516 0
+61 2 8627 7895
Fax 132516 0
Email 132516 0
[email protected]

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
No additional documents have been identified.