Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001693819
Ethics application status
Approved
Date submitted
11/11/2021
Date registered
10/12/2021
Date last updated
1/06/2024
Date data sharing statement initially provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Bright Light Therapy for Adolescent Depression
Scientific title
Bright Light Therapy for Adolescent Depression: Effects on Sleep and Mental Health
Secondary ID [1] 305774 0
Nil
Universal Trial Number (UTN)
U1111-1271-5133
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 324279 0
Condition category
Condition code
Mental Health 321772 321772 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bright Light Therapy
Participants allocated to receive Bright Light Therapy will be given basic (age appropriate) information (designed for this study) regarding sleep and the circadian rhythm. Treatment will involve individualised behavioural instructions, including how and when to use the Re-timer glasses and when to avoid bright light in the evening. The participants will be instructed to wear Re-Timer bright light glasses for between 30-60 minutes daily, for three weeks total. Behavioural instructions will differ for each participant, depending on the severity of sleep timing delay and desired bed and wake up times. Wake up times will be advanced by half an hour each morning until a wake up time of 6am is achieved (bright light therapy treatment sessions 1 and 2). Any issues that arise, regarding treatment implementation (e.g., social obligations conflicting with treatment etc.), can be discussed with the psychologist in bright light therapy treatment sessions 2 and 3. Once this desired wake up time is achieved, a period of consolidation will occur, where the participant maintains a consistent sleep schedule (e.g., set bed times and wake up times), whilst still using the bright light glasses (bright light therapy treatment session 2 and 3), and relapse prevention instructions will be provided (bright light therapy treatment session 3).
Brief Behavioural Activation for Adolescent Depression
Brief behavioural activation (Brief BA) for adolescent depression is a low-intensity, brief, structured behavioural intervention that can be delivered by a range of healthcare professionals (Pass, Lejuez & Reynolds, 2017). Brief BA is delivered over 8 1-hour sessions across 6 weeks (separate from bright light therapy sessions, yet commencing immediately after completion of the 3 week bright light therapy intervention/ sleep monitoring). Psychologists work with adolescents and their parent, following a structured workbook. Brief BA involves identifying how young people spend their time (activity monitoring) and what matters most to them (i.e., their values). This information is then used to schedule valued activities into the young person’s daily life, to increase rewarding experiences. Adolescents will complete an activity log out of session (approx. 10 mins daily, returned in session) and will complete valued activities (duration will vary per participant).
Participants will be randomly allocated to receive either bright light therapy plus brief behavioural activation or brief behavioural activation alone. Whilst participants in the bright light therapy (BLT) group receive undergo BLT (3 weeks), participants in the brief behavioural activation alone group will monitor their sleep. Treatment will be delivered online via videoconferencing.
Intervention code [1] 322175 0
Behaviour
Intervention code [2] 322176 0
Treatment: Devices
Comparator / control treatment
Participants in the brief behavioural activation alone group (control) will monitor their sleep for three weeks prior to receiving brief behavioural activation.
Control group
Active

Outcomes
Primary outcome [1] 329526 0
Depression:

Change in Revised Child Anxiety and Depression Scale scores.
Timepoint [1] 329526 0
RCADS: Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation (primary endpoint), 1 month follow-up, 6 month follow-up.
Primary outcome [2] 329771 0
Depression:

Percentage with Schedule for Affective Disorders and Schizophrenia or School aged Children (K-SADS) diagnosed depression
Timepoint [2] 329771 0
K-SADS: Pre-treatment, Post-treatment (primary endpoint), 1 month follow-up and 6 month follow-up.
Secondary outcome [1] 402868 0
Anxiety:

Change in Revised Child Anxiety and Depression Scale scores.

Timepoint [1] 402868 0
RCADS: Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation, 1 month follow-up, 6 month follow-up.
Secondary outcome [2] 402869 0
Sleep:

Change in sleep diary sleep parameters (e.g., bed time, rise time, sleep onset latency, total sleep time, sleep efficiency).
Timepoint [2] 402869 0
Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation, 1 month follow-up, 6 month follow-up.
Secondary outcome [3] 402870 0
Daytime Functioning:

Change in Pediatric Daytime Sleepiness Scale scores.
Timepoint [3] 402870 0
Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation, 1 month follow-up, 6 month follow-up.
Secondary outcome [4] 403720 0
Sleep:

Change in objective (Dreem) sleep parameters (e.g., sleep onset latency, total sleep time, sleep efficiency, percentage/time spent in REM, N3 etc.).
Timepoint [4] 403720 0
Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation, 1 month follow-up, 6 month follow-up.
Secondary outcome [5] 403721 0
Sleep:

Change in Insomnia Severity Index scores.
Timepoint [5] 403721 0
Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation, 1 month follow-up, 6 month follow-up.
Secondary outcome [6] 404049 0
Daytime Functioning:

Change in Flinders Fatigue Scale scores.
Timepoint [6] 404049 0
Pre-treatment, post-bright light therapy/ control, post-brief behavioural activation, 1 month follow-up, 6 month follow-up.

Eligibility
Key inclusion criteria
Meet diagnostic criteria for Major or Persistent Depressive Disorder.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be ineligible to participate if they have Bipolar Disorder, unmanaged psychotic symptoms, a history of seizure disorder and/or if they have vision problems (i.e., no light perception, glaucoma). To minimise risk, individuals who are actively suicidal and/or are in physically or sexually abusive environments will not be eligible to participate.

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)
After eligibility is determined, allocation will involve contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (block size 4, 6)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
120 participants are needed to detect small-to-medium differences between the two groups across 5 time-points with 80% power.

Linear Mixed Model Regressions will be used for statistical analysis.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/02/2022
Actual
2/09/2022
Date of last participant enrolment
Anticipated
1/02/2026
Actual
9/10/2023
Date of last data collection
Anticipated
20/09/2026
Actual
Sample size
Target
120
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310131 0
Charities/Societies/Foundations
Name [1] 310131 0
Raine Medical Research Foundation
Country [1] 310131 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Highway, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 311203 0
None
Name [1] 311203 0
Address [1] 311203 0
Country [1] 311203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309819 0
University of Western Australia Human Ethics Committee
Ethics committee address [1] 309819 0
Stirling Highway, Crawley WA 6009
Ethics committee country [1] 309819 0
Australia
Date submitted for ethics approval [1] 309819 0
Approval date [1] 309819 0
23/06/2021
Ethics approval number [1] 309819 0
2021/ET000061

Summary
Brief summary
The current study aims to evaluate to what extent inclusion of bright light therapy as an adjunct to the treatment for depression, improves sleep and mental health outcomes for young people with depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115498 0
Dr Cele Richardson
Address 115498 0
University of Western Australia, Stirling Highway, Crawley WA 6009
Country 115498 0
Australia
Phone 115498 0
+61864883141
Fax 115498 0
Email 115498 0
cele.richardson@uwa.edu.au
Contact person for public queries
Name 115499 0
Dr Cele Richardson
Address 115499 0
University of Western Australia. Stirling Highway, Crawley WA 6009
Country 115499 0
Australia
Phone 115499 0
+61864883141
Fax 115499 0
Email 115499 0
cele.richardson@uwa.edu.au
Contact person for scientific queries
Name 115500 0
Dr Cele Richardson
Address 115500 0
University of Western Australia. Stirling Highway, Crawley WA 6009
Country 115500 0
Australia
Phone 115500 0
+61864883141
Fax 115500 0
Email 115500 0
cele.richardson@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data will be shared after de-identification only. Participant data of published results and other available data will be shared upon reasonable request.
When will data be available (start and end dates)?
Data will be made available following publication of outcomes, and will remain available as long as data is stored (in compliance with retention policies).
Available to whom?
Only researchers who provide a methodologically sound proposal will have access to the data.
Available for what types of analyses?
Methodologically sound projects and meta-analyses.
How or where can data be obtained?
By contacting principal investigator at cele.richardson@uwa.edu.au.


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.