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Trial registered on ANZCTR


Trial ID
ACTRN12615000196549
Ethics application status
Approved
Date submitted
9/08/2014
Date registered
2/03/2015
Date last updated
2/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phototherapy in young people with depression
Scientific title
Phototherapy in young people with depression; Investigating associations between changes in actigraphic sleep-wake profile and depressive symptoms
Secondary ID [1] 285132 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292692 0
Condition category
Condition code
Mental Health 293008 293008 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times.

Participants are encouraged to complete the light exposure sessions for 60 minutes each day, but are asked to engage in these sessions even if they do have to interrupt them earlier. Participants are also instructed to progressively shift their schedule 15 minutes earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7.30am is reached (in which case, participants are instructed to keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they are instructed to keep their wake-up times stable and do the light exposure sessions upon awakening across the four weeks of the intervention.

During the intervention, participants are asked to note down the start and stop times of each bright light exposure session in a daily diary. Adherence is also monitored and promoted through weekly phone calls.
Intervention code [1] 289981 0
Treatment: Devices
Intervention code [2] 289982 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292866 0
Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)

Timepoint [1] 292866 0
between baseline and post (4 weeks) intervention
Secondary outcome [1] 309839 0
Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Timepoint [1] 309839 0
score between baseline and follow up (8 weeks)
Secondary outcome [2] 309840 0
Associations between changes in sleep wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Timepoint [2] 309840 0
between baseline and post (4 weeks) intervention
Secondary outcome [3] 309841 0
Associations between the initial sleep wake profile (mean sleep onset time, offset time efficiency and acrophase), as measured by actigraphy, and change in depression severity as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)
Timepoint [3] 309841 0
baseline and post (4 weeks) intervention
Secondary outcome [4] 309842 0
Change in Leeds Sleep Evaluation Questionnaire score
Timepoint [4] 309842 0
between baseline and post (4 weeks) intervention
Secondary outcome [5] 309863 0
Change in Fatigue Severity Scale score
Timepoint [5] 309863 0
between baseline and post (4 weeks) intervention

Eligibility
Key inclusion criteria
Quick Inventory of Depressive Symptomatology score > 6
First episode of depression before age 25
Currently engaged in, or about to start psychosocial treatment in one of the BMRI clinics.
Minimum age
16 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
b) Other primary psychiatric disorders aside from anxiety disorders;
c) Significant alcohol or other substance dependence;
d) Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study)
e) Use of medications that may interact with light to produce a photoallergic reaction.
f) Eye or skin condition which may interact with bright light exposure;
g) Regular shift-work within 60-days prior to entry into the study;
h) Recent transmeridian travel.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The core analyses will consist of:
a) Assessment of changes in level of depression (QIDS)

b) Correlations between changes in sleep-phase actigraphy variables (i.e. sleep onset, sleep offset, acrophase; i.e. baseline measure minus week-4 measure) and changes in QIDS scores (i.e. baseline measure minus week-4 measure)

c) Correlations between initial sleep-phase actigraphy variables (i.e. sleep onset, sleep offset, acrophase at baseline) and changes in self-reported depressive symptoms (i.e. baseline measure minus week-4 measure)

d) Correlations between changes in subjective sleep and fatigue (i.e. Leeds Sleep Evaluation Questionnaire score
and Fatigue Severity Scale score) (i.e. baseline measure minus week-4 measure) and changes in self-reported depressive symptoms (i.e. baseline measure minus week-4 measure)

e) Repeated measures ANOVAs comparing QIDS scores, Leeds Sleep Evaluation Questionnaire scores and Fatigue Severity Scale scores at baseline and after 2, 4 and 8 weeks of treatment.

Power calculations based on reported correlations between circadian realignment and antidepressant response after morning bright light exposure (Terman, 2001) suggest that a sample size of 38 participants would be required to detect a correlation at a = .05 with a power of 0.80.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289741 0
Government body
Name [1] 289741 0
Clinical Research Excellence in Interdisciplinary Sleep Health (571421)
Address [1] 289741 0
Centre for Integrated Research and Understanding of Sleep
PO Box M77
Missenden Road
Camperdown NSW 2050
Australia
Country [1] 289741 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 288433 0
None
Name [1] 288433 0
Address [1] 288433 0
Country [1] 288433 0
Other collaborator category [1] 278226 0
Individual
Name [1] 278226 0
Prof Nick Glozier
Address [1] 278226 0
Brain and Mind Research Institute
94 Mallett St, Camperdown
NSW 2050
Country [1] 278226 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291474 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291474 0
Research Integrity
Research Portfolio
Level 2, Margaret Telfer
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 291474 0
Australia
Date submitted for ethics approval [1] 291474 0
Approval date [1] 291474 0
24/04/2013
Ethics approval number [1] 291474 0
2013/208 and 2013/986

Summary
Brief summary
Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered.

The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50558 0
Dr Rebecca Robillard
Address 50558 0
Sleep and Depression Research Units,
Institute of Mental Health Research, University of Ottawa
1145 Carling Avenue
Ottawa, Ontario K1Z 7K4
Country 50558 0
Canada
Phone 50558 0
+1 613 722 6521 ext 6279
Fax 50558 0
Email 50558 0
reb.robillard@gmail.com
Contact person for public queries
Name 50559 0
Dr Rebecca Robillard
Address 50559 0
Sleep and Depression Research Units,
Institute of Mental Health Research, University of Ottawa
1145 Carling Avenue
Ottawa, Ontario K1Z 7K4
Country 50559 0
Canada
Phone 50559 0
+1 613 722 6521 ext 6279
Fax 50559 0
Email 50559 0
reb.robillard@gmail.com
Contact person for scientific queries
Name 50560 0
Dr Rebecca Robillard
Address 50560 0
Sleep and Depression Research Units,
Institute of Mental Health Research, University of Ottawa
1145 Carling Avenue
Ottawa, Ontario K1Z 7K4
Country 50560 0
Canada
Phone 50560 0
+1 613 722 6521 ext 6279
Fax 50560 0
Email 50560 0
reb.robillard@gmail.com