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Suicidal IdeationNCT05616819

Effect of Morning Light Exposure on Mood

A study testing Active light exposure in people with Suicidal Ideation and Regulation, Emotion, run by University of Arizona at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Suicidal Ideation, Regulation, Emotion
What is being tested?
Active light exposure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
1 siteUnited States
Study dates
1 Jul 2023to 1 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

William D Killgore, Ph.D. contact

(520) 621-0605

killgore@arizona.edu

Camryn Wellman contact

camrynwellman@arizona.edu

United States1 site, 1 recruiting
  • University of Arizona

    Tucson, Arizona, 85719

    William DS Killgore, 520-621-0605, killgore@psychiatry.arizona.edu

    Camryn Wellman, camrynwellman@arizona.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Active light exposure, Placebo light exposure
Keywords
Circadian Rhythm, Blue Light
Medical subject headings
Suicidal Ideation, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active light exposureOther

    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 light exposureOther

    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.

Study groups in NCT05616819
Study groupRoleWhat they receive
Treatment Order AActive comparatorActive light condition for 2 weeks, a 2-week washout period, and 2 weeks of placebo light treatment.
Receives: Other: Active light exposure
Treatment Order BPlacebo comparatorPlacebo light treatment for 2 weeks, a 2-week washout period, and 2 weeks of active light treatment.
Receives: Other: Placebo light exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: 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)
  1. Total Sleep Time

    The total time individuals are asleep during intervention.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2022
  2. Study start1 Jul 2023
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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) 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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616819
Sponsor's protocol ID
STUDY00002038
Status last verified
Oct 2025
First submitted
20 Oct 2022
Last updated
4 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Al-Karawi D, Jubair L. Bright light therapy for nonseasonal depression: Meta-analysis of clinical trials. J Affect Disord. 2016 Jul 1;198:64-71. doi: 10.1016/j.jad.2016.03.016. Epub 2016 Mar 15.

    PubMed 27011361
  • 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.

    PubMed 33841300
  • 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.

    PubMed 26806862
  • 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.

    PubMed 27253770
  • Baron KG, Reid KJ. Circadian misalignment and health. Int Rev Psychiatry. 2014 Apr;26(2):139-54. doi: 10.3109/09540261.2014.911149.

    PubMed 24892891
  • Bedrosian TA, Nelson RJ. Timing of light exposure affects mood and brain circuits. Transl Psychiatry. 2017 Jan 31;7(1):e1017. doi: 10.1038/tp.2016.262.

    PubMed 28140399
  • Bernert RA, Kim JS, Iwata NG, Perlis ML. Sleep disturbances as an evidence-based suicide risk factor. Curr Psychiatry Rep. 2015 Mar;17(3):554. doi: 10.1007/s11920-015-0554-4.

    PubMed 25698339
  • Blume C, Garbazza C, Spitschan M. Effects of light on human circadian rhythms, sleep and mood. Somnologie (Berl). 2019 Sep;23(3):147-156. doi: 10.1007/s11818-019-00215-x. Epub 2019 Aug 20.

    PubMed 31534436
  • Brainard GC, Sliney D, Hanifin JP, Glickman G, Byrne B, Greeson JM, Jasser S, Gerner E, Rollag MD. Sensitivity of the human circadian system to short-wavelength (420-nm) light. J Biol Rhythms. 2008 Oct;23(5):379-86. doi: 10.1177/0748730408323089.

    PubMed 18838601
  • Byrne SP, McCarthy E, DeViva JC, Southwick SM, Pietrzak RH. Prevalence, risk correlates, and health comorbidities of insomnia in US military veterans: results from the 2019-2020 National Health and Resilience in Veterans Study. J Clin Sleep Med. 2021 Jun 1;17(6):1267-1277. doi: 10.5664/jcsm.9182.

    PubMed 33656983
  • Canton JL, Smith MR, Choi HS, Eastman CI. Phase delaying the human circadian clock with a single light pulse and moderate delay of the sleep/dark episode: no influence of iris color. J Circadian Rhythms. 2009 Jul 17;7:8. doi: 10.1186/1740-3391-7-8.

    PubMed 19615064
  • Czeisler CA, Weitzman Ed, Moore-Ede MC, Zimmerman JC, Knauer RS. Human sleep: its duration and organization depend on its circadian phase. Science. 1980 Dec 12;210(4475):1264-7. doi: 10.1126/science.7434029.

    PubMed 7434029
  • Emens JS, Berman AM, Thosar SS, Butler MP, Roberts SA, Clemons NA, Herzig MX, McHill AW, Morimoto M, Bowles NP, Shea SA. Circadian rhythm in negative affect: Implications for mood disorders. Psychiatry Res. 2020 Nov;293:113337. doi: 10.1016/j.psychres.2020.113337. Epub 2020 Aug 4.

    PubMed 32777620
  • Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.

    PubMed 15800134
  • Hanifin JP, Lockley SW, Cecil K, West K, Jablonski M, Warfield B, James M, Ayers M, Byrne B, Gerner E, Pineda C, Rollag M, Brainard GC. Randomized trial of polychromatic blue-enriched light for circadian phase shifting, melatonin suppression, and alerting responses. Physiol Behav. 2019 Jan 1;198:57-66. doi: 10.1016/j.physbeh.2018.10.004. Epub 2018 Oct 5.

    PubMed 30296404

Questions about this trial

What is this clinical trial studying?

A study testing Active light exposure in people with Suicidal Ideation and Regulation, Emotion, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact William D Killgore, Ph.D. ((520) 621-0605, killgore@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05616819, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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