Effect of Morning Light Exposure on Mood (BLM)

October 31, 2025 updated by: University of Arizona

Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective is to determine the effectiveness of daily morning light therapy for regulating the circadian rhythm to improve mood and reduce suicidal thinking. Our working hypotheses are that daily exposure to the active 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, investigators aim to 1) determine the effectiveness of daily morning active light condition therapy for regulating circadian timing and sleep, 2) determine the effectiveness of daily morning active light condition therapy 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 active light condition therapy versus a placebo light therapy on measured sleep and mental health outcomes. Participants will complete two weeks of morning active light condition therapy 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 placebo light-emitting diode (LEDs), in a counterbalanced order, separated by a two-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 continuous actigraphy and daily brief sleep/mood/suicidal ideation logs. It is important to note that investigators also monitored sleep/circadian rhythms via 5-channel at-home EEG recordings for the first few participants who completed the study before investigators removed the use of the EEG recording device from the study protocol due to prohibitive costs associated with using the manufacturer's software.

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of psychotic disorder or manic episodes
  • Bipolar disorder
  • Diseases of the eye
  • Have had cataract surgery
  • Frequent and light-sensitive migraine headaches
  • Self-reported plan to regularly engage in nightshift work during the 6-week course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment Order A
Active light condition for 2 weeks, a 2-week washout period, and 2 weeks of placebo light treatment.
Other: Active light exposure
Active 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 2-week washout period, and 2 weeks of active light treatment.
Other: Placebo light exposure
Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal Ideation: Depression
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.
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.
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.
Suicidal Ideation: Association with Death
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.
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.
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.
Suicidal Ideation: 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.
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.
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.
Suicidal Ideation: Suicidal Cognitions
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.
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.
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.
Suicidal Ideation: Loneliness
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.
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.
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.
Suicidal Ideation: Burdensomeness
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.
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.
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.
Suicidal Ideation: Resilience
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: During both intervention periods, consisting of 14 days of daily measures each (28 days total).
The total time individuals are asleep during intervention.
During both intervention periods, consisting of 14 days of daily measures each (28 days total).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

U.S. Army Medical Research Acquisition Activity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. All data that will be shared from this clinical trial will be shared in summary data sets.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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