Phototherapy in Young People With Depression

NCT ID: NCT02448433

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phototherapy

Group Type: OTHER

Phototherapy light-emitting glasses

Intervention Type: DEVICE

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 min each day. Participants are also instructed to progressively shift their schedule 15 min 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 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 do the light exposure sessions upon awakening across the four weeks of the intervention.

During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.

Interventions

Phototherapy light-emitting glasses

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 min each day. Participants are also instructed to progressively shift their schedule 15 min 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 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 do the light exposure sessions upon awakening across the four weeks of the intervention.

During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls.

Intervention Type: DEVICE

Other Intervention Names

Re-timer

Eligibility Criteria

Inclusion Criteria

1. Quick Inventory of Depressive Symptomatology score > 6;

2. First episode of depression before age 25;

3. Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.

Exclusion Criteria

1. Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;

2. Other primary psychiatric disorders aside from anxiety disorders;

3. Significant alcohol or other substance dependence;

4. 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);

5. Use of medications that may interact with light to produce a photoallergic reaction;

6. Eye or skin condition which may interact with bright light exposure;

7. Regular shift-work within 60-days prior to entry into the study;

8. Recent transmeridian travel.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Rébecca Robillard

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brain and Mind Research Insitute, The University of Sydney

Camperdown, New South Wales, Australia

Site Status: SUSPENDED

Sleep and Depression Research Units, Institute of Mental Health Research, University of Ottawa

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Australia; Canada

Central Contacts

Rébecca Robillard, PhD

Role: CONTACT

reb.robillard@gmail.com

+1 613 722 6521 ext. 6279

Facility Contacts

Rébecca Robillard, PhD

Role: primary

reb.robillard@gmail.com

+1 613 722 6521 ext. 6279

Other Identifiers

2015007

Identifier Type: -

Identifier Source: org_study_id