Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000759594p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2024
Date registered
20/06/2024
Date last updated
20/06/2024
Date data sharing statement initially provided
20/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Project SCIMA: A Sleep and Circadian intervention for Mental Health in Athletes
Scientific title
Project SCIMA: A Sleep Regularity and Circadian Alignment intervention for Mental Health and Performance in Athletes. A Pilot Trial.
Secondary ID [1] 312083 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
circadian misalignment 333722 0
Condition category
Condition code
Mental Health 330402 330402 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 330403 330403 0 0
Anxiety
Neurological 330747 330747 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our study will involve athletes who will all be exposed to the intervention. The intervention will be conducted both face to face and over telehealth. The group size will be approximately 30-40 athletes. Our intervention is a sleep and circadian protocol called SCIMA. The SCIMA protocol was developed for this study through an iterative coproduction process, involving guidance from athletes as well as recommendations from circadian, mental health and sleep experts. We also incorporated prior evidence, some existing materials and used the cognitive behavioural therapy structure to create our own practitioner/ client manual.

During the coproduction process, athletes were asked during individual interviews about their capability, opportunity and motivation to carry out certain sleep behaviours proposed by the researchers using the COM-B model of behaviour change. The athletes’ responses were used as a guide for protocol development.

The main guidelines of SCIMA are to establish a regular sleep–wake schedule (based on the current evidence on sleep regularity guidelines) that has been informed by individual circadian biology. The intervention contains cognitive-behavioural components to assist in maintaining this routine and includes group psychoeducation, weekly behavioural coaching, light therapy and blue light block glasses use as well as general sleep and circadian hygiene recommendations. The practitioners who would administer this manual with the athlete have the relevant training and experience in clinical work, sleep interventions and chronobiology.

Further components:
1) 1x group psychoeducation session (30-40 minutes) (e.g., what the intervention involves, education about the relationship between sleep regularity, circadian rhythms and mental health, importance of maintaining these behaviours to derive benefits, healthy sleep habits such as dimming lighting in the evening, having a wind down routine)
2) 4x Individual behavioural coaching sessions (20-30 minutes weekly, 1 in person and the following 3 over zoom) (e.g., the athlete's individual goals for the intervention, what went well/ not well during the week, review of subjective sleep diaries and objective wrist monitor date)
3) The athletes will be given blue light blocking glasses for the intervention period to use one hour before their sleep onset regularity window.
4) Morning light exposure: The athletes will be given a ‘light therapy device’ to keep for the intervention period. They will be asked to either get 15 minutes of natural sunlight when they wake up or to use the light therapy device if natural sunlight is not possible.

The intervention will be conducted over a period of 4 weeks as well as a prior 2-week baseline assessment.
Adherence to the intervention will be measured through surveys, goal attainment scaling and both objective/ subjective measure of sleep.
Intervention code [1] 328535 0
Behaviour
Intervention code [2] 328536 0
Lifestyle
Intervention code [3] 328537 0
Treatment: Other
Comparator / control treatment
No control group. This is a pilot trial. The control will be the participants baseline period. Measurements will be assessed over a two-week baseline period.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338161 0
Mental Health

Timepoint [1] 338161 0
Baseline and immediately post-completion of 4-week intervention
Follow up 3 months after the intervention
Primary outcome [2] 338162 0
Psychological Strain
Timepoint [2] 338162 0
Baseline and immediately post-completion of 4-week intervention
Follow up 3 months after the intervention
Primary outcome [3] 338163 0
Sleep Regularity
Timepoint [3] 338163 0
Daily for the duration of the 4-week intervention
Secondary outcome [1] 434787 0
Sport performance
Timepoint [1] 434787 0
baseline and immediately post-completion of 4-week intervention
Secondary outcome [2] 434788 0
cognition (executive function)
Timepoint [2] 434788 0
baseline and immediately post-completion of 4-week intervention
Secondary outcome [3] 434789 0
Menstrual Cycle tracking
Timepoint [3] 434789 0
Daily for the duration of the 4-week intervention
Secondary outcome [4] 434790 0
Intervention Adherence
Timepoint [4] 434790 0
Weekly for the duration of the 4-week intervention
Secondary outcome [5] 436244 0
Mood (This is an additional primary outcome)
Timepoint [5] 436244 0
Daily for the duration of the 4-week intervention
Secondary outcome [6] 436245 0
Circadian (This is an additional primary outcome)
Timepoint [6] 436245 0
baseline and immediately post 4-week intervention
Secondary outcome [7] 436246 0
Sleep (this is an additional primary outcome)
Timepoint [7] 436246 0
Daily for the duration of the 4-week intervention
Secondary outcome [8] 436279 0
cognition (memory)
Timepoint [8] 436279 0
baseline and immediately post 4-week intervention
Secondary outcome [9] 436280 0
cognition (processing speed)
Timepoint [9] 436280 0
baseline and immediately post 4-week intervention
Secondary outcome [10] 436281 0
cognition (attention and working memory)
Timepoint [10] 436281 0
baseline and immediately post 4 week intervention

Eligibility
Key inclusion criteria
1) semi-professional and/or professional athlete
2) At least 18 years of age
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316441 0
University
Name [1] 316441 0
Monash university
Country [1] 316441 0
Australia
Primary sponsor type
University
Name
Monash univeristy
Address
Country
Australia
Secondary sponsor category [1] 318611 0
None
Name [1] 318611 0
Address [1] 318611 0
Country [1] 318611 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315233 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315233 0
Ethics committee country [1] 315233 0
Australia
Date submitted for ethics approval [1] 315233 0
31/05/2024
Approval date [1] 315233 0
Ethics approval number [1] 315233 0

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

Contacts
Principal investigator
Name 134074 0
Dr Elise Facer Childs
Address 134074 0
Monash University, Building 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 134074 0
Australia
Phone 134074 0
+61415058693
Fax 134074 0
Email 134074 0
[email protected]
Contact person for public queries
Name 134075 0
Elie Walsh
Address 134075 0
Monash University, Building 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 134075 0
Australia
Phone 134075 0
+61415058693
Fax 134075 0
Email 134075 0
[email protected]
Contact person for scientific queries
Name 134076 0
Elie Walsh
Address 134076 0
Monash University, Building 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 134076 0
Australia
Phone 134076 0
+61 0415058693
Fax 134076 0
Email 134076 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.