Effect of Morning Light Exposure on Mood

Suicidal Ideation Clinical Trial

Official title:

Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616819
• Other study ID #: STUDY00002038
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: University of Arizona
• Contact: William D Killgore, Ph.D.
• Phone: (520) 621-0605
• Email: killgore[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 use of prescription stimulants

• Self-reported plan to engage in nightshift work during the 6-week course of the study

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	U.S. Army Medical Research Acquisition Activity

Country where clinical trial is conducted

United States, 

References & Publications (36)

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Alkozei A, Dailey NS, Bajaj S, Vanuk JR, Raikes AC, Killgore WDS. Exposure to Blue Wavelength Light Is Associated With Increases in Bidirectional Amygdala-DLPFC Connectivity at Rest. Front Neurol. 2021 Mar 26;12:625443. doi: 10.3389/fneur.2021.625443. eCollection 2021. — View Citation

Alkozei A, Smith R, Killgore WD. Exposure to blue wavelength light modulates anterior cingulate cortex activation in response to 'uncertain' versus 'certain' anticipation of positive stimuli. Neurosci Lett. 2016 Mar 11;616:5-10. doi: 10.1016/j.neulet.2016.01.034. Epub 2016 Jan 22. — View Citation

Alkozei A, Smith R, Pisner DA, Vanuk JR, Berryhill SM, Fridman A, Shane BR, Knight SA, Killgore WD. Exposure to Blue Light Increases Subsequent Functional Activation of the Prefrontal Cortex During Performance of a Working Memory Task. Sleep. 2016 Sep 1;39(9):1671-80. doi: 10.5665/sleep.6090. — View Citation

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Killgore WDS, Vanuk JR, Shane BR, Weber M, Bajaj S. A randomized, double-blind, placebo-controlled trial of blue wavelength light exposure on sleep and recovery of brain structure, function, and cognition following mild traumatic brain injury. Neurobiol Dis. 2020 Feb;134:104679. doi: 10.1016/j.nbd.2019.104679. Epub 2019 Nov 18. — View Citation

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Raikes AC, Dailey NS, Forbeck B, Alkozei A, Killgore WDS. Daily Morning Blue Light Therapy for Post-mTBI Sleep Disruption: Effects on Brain Structure and Function. Front Neurol. 2021 Feb 5;12:625431. doi: 10.3389/fneur.2021.625431. eCollection 2021. — View Citation

Raikes AC, Dailey NS, Shane BR, Forbeck B, Alkozei A, Killgore WDS. Daily Morning Blue Light Therapy Improves Daytime Sleepiness, Sleep Quality, and Quality of Life Following a Mild Traumatic Brain Injury. J Head Trauma Rehabil. 2020 Sep/Oct;35(5):E405-E421. doi: 10.1097/HTR.0000000000000579. — View Citation

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Total Sleep Time	The total time individuals are asleep during intervention.	During both intervention periods, consisting of 14 days of daily measures each (28 days total).