Effect of Morning Light Exposure on Mood

NCT05616819 | Recruiting DMC

• 1 other identifier: STUDY00002038
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Suicidal Ideation; Regulation, Emotion

Keywords

Circadian Rhythm; Blue Light

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Total Sleep Time

  During both intervention periods, consisting of 14 days of daily measures each (28 days total).

Study Arms (2)

Treatment Order A

ACTIVE COMPARATOR

Active light condition for 2 weeks, a 2-week washout period, and 2 weeks of placebo light treatment.

Other: Active light exposure

Treatment Order B

PLACEBO COMPARATOR

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

Other: Placebo light exposure

Interventions

Active light exposure OTHER

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.

Treatment Order A

Placebo light exposure OTHER

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.

Treatment Order B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• U.S. Army Medical Research Acquisition Activity: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Suicidal Ideation; Emotional Regulation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Central Study Contacts

William D Killgore, Ph.D.

CONTACT

(520) 621-0605; killgore@arizona.edu

Camryn Wellman

CONTACT

camrynwellman@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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) Active Light Condition Therapy (ALT) for 2 weeks, a 2-week washout period, and 2 weeks of Placebo Light therapy, or Order B) PLT for 2 weeks, a 2-week washout period, and 2 weeks of ALT.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 15, 2022
• Study Start: July 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)