Clinical trial NCT05616819: Effect of Morning Light Exposure on Mood
Official title: Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Regulation, Emotion
Keywords: Circadian Rhythm
Blue Light
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research Acquisition Activity
First posted: 2022-11-15
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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, 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.

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, we 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 we also monitored sleep/circadian rhythms via 5-channel at-home EEG recordings for the first few participants who completed the study before we removed the use of the EEG recording device from the study protocol due to prohibitive costs associated with using the manufacturer's software.

Eligibility criteria: 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

Primary outcomes:
measure: Suicidal Ideation: Depression
timeFrame: 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.
measure: Suicidal Ideation: Association with Death
timeFrame: 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.
measure: Suicidal Ideation: Hopelessness
timeFrame: 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.
measure: Suicidal Ideation: Suicidal Cognitions
timeFrame: 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.
measure: Suicidal Ideation: Loneliness
timeFrame: 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.
measure: Suicidal Ideation: Burdensomeness
timeFrame: 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.
measure: Suicidal Ideation: Resilience
timeFrame: 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:
measure: Total Sleep Time
timeFrame: During both intervention periods, consisting of 14 days of daily measures each (28 days total).
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
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