BLM: Effect of Blue Light Exposure on Mood

Sponsor

University of Arizona (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05616819

Collaborator

U.S. Army Medical Research Acquisition Activity (U.S. Fed)

480

Enrollment

Arms

34.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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, we 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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation Regulation, Emotion	Other: Blue light exposure Other: Amber light exposure	N/A

Detailed Description

The objective is to determine the effectiveness of daily morning blue light therapy (BLT) for regulating the circadian rhythm to improve mood and reduce suicidal thinking. Our working hypotheses are that daily exposure to morning blue light for two weeks will 1) lead to a phase advance entrainment of sleep timing relative to a placebo light therapy, 2) lead to improved/sustained mental health outcomes, including suicidal ideation, relative to a placebo light therapy, and that 3) most military Service members will rate the use of a light "headset" device acceptable as a treatment option after their experience.

Over a 3-year period of performance, we aim to 1) determine the effectiveness of daily morning BLT for regulating circadian timing and sleep, 2) determine the effectiveness of daily morning BLT for sustaining or improving mental health outcomes, including suicidal ideation, relative to placebo light therapy, and 3) determine the acceptability and "buy-in" from military personnel using a daily light headset device.

During this study, 400 military personnel will complete a double-blind, placebo-controlled, counterbalanced, crossover design study of the effects of 30-minutes of daily morning blue light therapy (BLT) versus amber placebo light therapy (PLT) on measured sleep and mental health outcomes. Participants will complete two weeks of morning BLT with a commercially available headset with four built-in light-emitting diode (LEDs) and internal compliance monitors, and two weeks wearing the same type of glasses fit with amber placebo light-emitting diode (LEDs), in a counterbalanced order, separated by a four-week washout period. An online assessment battery for mental health and suicidal ideation will be completed before and after each treatment period, and sleep/circadian rhythms will be monitored throughout via 5-channel at-home EEG recordings, continuous actigraphy and daily brief sleep/mood/suicidal ideation logs.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

All recruitment, data collection, and testing will occur online, through remote interactions. Via a web-based portal, participants will complete a baseline assessment battery to document their sleep habits, mental health, and suicidal ideation. After the baseline assessment, participants will be randomly assigned to one of two treatment orders: Order A) BLT for 2 weeks, a 4-week washout period, and 2 weeks of PLT, or Order B) PLT for 2 weeks, a 4-week washout period, and 2 weeks of BLT.All recruitment, data collection, and testing will occur online, through remote interactions. Via a web-based portal, participants will complete a baseline assessment battery to document their sleep habits, mental health, and suicidal ideation. After the baseline assessment, participants will be randomly assigned to one of two treatment orders: Order A) BLT for 2 weeks, a 4-week washout period, and 2 weeks of PLT, or Order B) PLT for 2 weeks, a 4-week washout period, and 2 weeks of BLT.

Masking:

Double (Participant, Investigator)

Masking Description:

Participants will not have any knowledge of which of the two condition groups they are apart of during or after the study. The investigator will not have any knowledge of which of the two condition groups the participant is apart of during or after the study. Condition groups will be randomly assigned via the web-based portal used for recruitment, data collection, and testing.

Primary Purpose:

Prevention

Official Title:

Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Order A Blue light treatment for 2 weeks, a 4-week washout period, and 2 weeks of placebo (amber) light treatment.	Other: Blue light exposure Blue 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 Comparator: Treatment Order B Placebo light treatment for 2 weeks, a 4-week washout period, and 2 weeks of blue light treatment.	Other: Amber light exposure Amber 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.

Arm

Intervention/Treatment

Active Comparator: Treatment Order A

Blue light treatment for 2 weeks, a 4-week washout period, and 2 weeks of placebo (amber) light treatment.

Other: Blue light exposure

Blue 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 Comparator: Treatment Order B

Placebo light treatment for 2 weeks, a 4-week washout period, and 2 weeks of blue light treatment.

Other: Amber light exposure

Amber 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.

Outcome Measures

Primary Outcome Measures

Suicidal Ideation: Depression [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.]
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.
Suicidal Ideation: Association with Death [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.]
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.
Suicidal Ideation: Hopelessness [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.]
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.
Suicidal Ideation: Suicidal Cognitions [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.]
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.
Suicidal Ideation: Loneliness [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.]
The mean response on the University of California Los Angeles Loneliness Scale (UCLALS), which measures an individuals subjective feelings of loneliness and social isolation. Higher scores indicate a greater feeling of loneliness.
Suicidal Ideation: Burdensomeness [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.]
The mean response on the Interpersonal Needs Questionnaire (INQ),which measures individual sense of perceived burdensomeness (PB) and thwarted belongingness (TB). Higher scores on these sub-scales indicate a greater desire for death/suicide.
Suicidal Ideation: Resilience [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.]
The mean response on the Connor-Davidson Resilience Scale (CD-RISC), which measures an individuals adaptability and ability to thrive in adversity. Higher scores on this scale indicated higher resilience which is inversely associated with suicidal ideation.

Secondary Outcome Measures

Total Sleep Time [During both intervention periods, consisting of 14 days of daily measures each (28 days total).]
The total time individuals are asleep during intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ages 18-60 years
English as primary language
At least an 8th grade reading level
Score ≥ 5 (i.e., mild depression or greater) on the Patient Health Questionnaire 9 (PHQ-9)

Exclusion Criteria:

Score in non-depressed range on Patient Health Questionnaire 9 (PHQ-9) (< 5)
History of psychotic disorder or manic episodes
Current or prior history of eye disease
History of migraine headaches
Current or prior history of sleep-related breathing disorders
Self-reported use of sedative hypnotic sleep medications or melatonin supplements
Self-reported use of prescription stimulants
Self-reported excessive use of caffeine (i.e., > 500 mg per day)
Plans to engage in nightshift work during the 8-week course of the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arizona
U.S. Army Medical Research Acquisition Activity

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT05616819

Other Study ID Numbers:

STUDY00002038

First Posted:

Nov 15, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arizona

Circadian Rhythm

Blue Light

Additional relevant MeSH terms:

Suicidal Ideation

Study Results

No Results Posted as of Nov 15, 2022