Effect of Morning Light Exposure on Mood

Официальное название

Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Suicidal Ideation: Depression [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (1)

• Total Sleep Time [Срок оценки: During both intervention periods, consisting of 14 days of daily measures each (28 days total).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Arizona — Tucson

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 27253770
• Baron KG, Reid KJ. Circadian misalignment and health. Int Rev Psychiatry. 2014 Apr;26(2):139-54. doi: 10.3109/09540261.2014.911149. PMID 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. PMID 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. PMID 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. PMID 31534436

Идентификаторы

NCT: NCT05616819 · STUDY00002038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗