Effect of Morning Light Exposure on Mood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Arizona
About this trial
Mood dysregulation and suicidal ideation are closely associated with disruption of sleep and circadian rhythms. Moreover, sleep problems and circadian disruption are commonplace features of military life. Critically, specifically timed light exposure plays a powerful role in regulating mood, circadian rhythms, and sleep-wake patterns. Therefore, investigators propose to conduct a large-scale clinical trial on the effectiveness of morning light exposure treatment for improving sleep-wake patterns, emotional and mental health, and suicidal thoughts in military personnel.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18-60 years
At least an 8th grade reading level
Score ≥ 5 (i.e., mild depression or greater) on the Patient Health Questionnaire 9 (PHQ-9)
Service member of any Armed Forces branch, including active duty, Reserve, or National Guard
Disqualifiers
Not actively serving in an Armed Force branch
Scored (i.e., < 5) range on the PHQ-9 (non-depressed)
Pregnant or trying to become pregnant
Breastfeeding
Trial design
Design model
Crossover
Treatments tested in this trial
Active light exposure
Other interventionActive light at the wave length of 470nm will be emitted for 30 minutes over a 2 week time frame, from commercially available ayo glasses, as a method to regulated circadian rhythm.
Placebo light exposure
Other interventionPlacebo light at the wave length of 578nm will be emitted for 30 minutes over a 2 week time frame, from commercially available ayo glasses, as a control to investigate the regulation of circadian rhythm.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Treatment Order AActive comparator 1 intervention
Group B: Treatment Order BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Suicidal Ideation: Depression
The mean response on the Beck Depression Inventory (BDI), which measures key symptoms of clinical depression. Higher scores on this measure indicate the presence of more severe depressive symptoms.
Time frame
Participants will be assessed the day before the initiation of the first two-week intervention period and the day following the conclusion of the first two-week intervention period. This will be repeated for the second two-week intervention period.2
Suicidal Ideation: Association with Death
The mean response on the Death Implicit Association Test (D-IAT), which measures the strength of an individuals implicit association between themselves and death. Positive scores: support a stronger association between 'Me-Death' and 'Not Me-Life' than for the opposite pairings; Negative scores: support a stronger association between 'Me-Life' and 'Not Me-Death' than for the opposite pairings. Scores closer to 1/-1 indicate a stronger association than those near 0.
Time frame
Participants will be assessed the day before the initiation of the first two-week intervention period and the day following the conclusion of the first two-week intervention period. This will be repeated for the second two-week intervention period.3
Suicidal Ideation: Hopelessness
The mean response on the Beck Hopelessness Scale (BHS), which measures hopelessness with a series of optimistic or pessimistic statements regarding thoughts about the future, motivation, and expectations. Higher scores on this scale indicate more severe hopelessness.
Time frame
Participants will be assessed the day before the initiation of the first two-week intervention period and the day following the conclusion of the first two-week intervention period. This will be repeated for the second two-week intervention period.4
Suicidal Ideation: Suicidal Cognitions
The mean response on the Suicidal Cognitions Revised (SCS-R), which predicts future suicidal attempts in patients who deny suicidal ideation and prior suicide attempts. Higher scores on this scale are associated with a greater likelihood of an individual attempting suicide in the future.
Time frame
Participants will be assessed the day before the initiation of the first two-week intervention period and the day following the conclusion of the first two-week intervention period. This will be repeated for the second two-week intervention period.Secondary outcomes
1
Total Sleep Time
The total time individuals are asleep during intervention.
Time frame
During both intervention periods, consisting of 14 days of daily measures each (28 days total).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
U.S. Army Medical Research Acquisition Activity
Collaborator
Source ClinicalTrials.gov