Phototherapy in young people with depression

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000196549
• Date of registration: 02/03/2015
• Prospective Registration: No
• Primary sponsor: University of Sydney
• 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
• Date of first enrolment: 24/05/2013
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000196549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Rebecca Robillard

• Name: Dr Rebecca Robillard

Key inclusion & exclusion criteria

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.

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.


Age minimum: 16 Years
Age maximum: 30 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Depression;
Depression

Mental Health - Depression

Intervention(s)

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.

Primary Outcome(s)

Change in severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR)

[between baseline and post (4 weeks) intervention ]

Secondary Outcome(s)

Change in Leeds Sleep Evaluation Questionnaire score[between baseline and post (4 weeks) intervention]

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) [baseline and post (4 weeks) intervention]

Change in depression as measured by the Quick Inventory of Depressive Symptomatology (QIDSA17-SR) [score between baseline and follow up (8 weeks) ]

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) [between baseline and post (4 weeks) intervention]

Change in Fatigue Severity Scale score
[between baseline and post (4 weeks) intervention ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Clinical Research Excellence in Interdisciplinary Sleep Health (571421)

Ethics review

Status: Approved
Approval date:
Contact:

The University of Sydney Human Research Ethics Committee