Effect of Morning Light Exposure on Mood
- Conditions
- Suicidal IdeationRegulation, Emotion
- Interventions
- Other: Active light exposureOther: Placebo light exposure
- Registration Number
- NCT05616819
- Lead Sponsor
- University of Arizona
- 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 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Order A Active light exposure Active light condition for 2 weeks, a 2-week washout period, and 2 weeks of placebo light treatment. Treatment Order B Placebo light exposure Placebo light treatment for 2 weeks, a 2-week washout period, and 2 weeks of active light treatment.
- Primary Outcome Measures
Name Time Method Suicidal Ideation: Resilience 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 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.
Suicidal Ideation: 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. 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.
Suicidal Ideation: Burdensomeness 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 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.
Suicidal Ideation: 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. 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.
Suicidal Ideation: Suicidal Cognitions 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 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.
Suicidal Ideation: Depression 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 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.
Suicidal Ideation: Association with Death 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 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.
- Secondary Outcome Measures
Name Time Method Total Sleep Time During both intervention periods, consisting of 14 days of daily measures each (28 days total). The total time individuals are asleep during intervention.
Trial Locations
- Locations (1)
University of Arizona
🇺🇸Tucson, Arizona, United States