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Effect of Blue Light Exposure on Mood (BLM)

Primary Purpose

Suicidal Ideation, Regulation, Emotion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blue light exposure
Amber light exposure
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Circadian Rhythm, Blue Light

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ages 18-60 years English as primary language At least an 8th grade reading level Score ≥ 5 (i.e., mild depression or greater) on the Patient Health Questionnaire 9 (PHQ-9) Exclusion Criteria: Score in non-depressed range on Patient Health Questionnaire 9 (PHQ-9) (< 5) History of psychotic disorder or manic episodes Current or prior history of eye disease History of migraine headaches Current or prior history of sleep-related breathing disorders Self-reported use of sedative hypnotic sleep medications or melatonin supplements Self-reported use of prescription stimulants Self-reported excessive use of caffeine (i.e., > 500 mg per day) Plans to engage in nightshift work during the 8-week course of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Treatment Order A

    Treatment Order B

    Arm Description

    Blue light treatment for 2 weeks, a 4-week washout period, and 2 weeks of placebo (amber) light treatment.

    Placebo light treatment for 2 weeks, a 4-week washout period, and 2 weeks of blue light treatment.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Total Sleep Time
    The total time individuals are asleep during intervention.

    Full Information

    First Posted
    October 20, 2022
    Last Updated
    November 7, 2022
    Sponsor
    University of Arizona
    Collaborators
    U.S. Army Medical Research Acquisition Activity
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05616819
    Brief Title
    Effect of Blue Light Exposure on Mood
    Acronym
    BLM
    Official Title
    Regulating Mood and Suicidal Ideation With Morning Light Exposure Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2026 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arizona
    Collaborators
    U.S. Army Medical Research Acquisition Activity

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation, Regulation, Emotion
    Keywords
    Circadian Rhythm, Blue Light

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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) BLT for 2 weeks, a 4-week washout period, and 2 weeks of PLT, or Order B) PLT for 2 weeks, a 4-week washout period, and 2 weeks of BLT.
    Masking
    ParticipantInvestigator
    Masking Description
    Participants will not have any knowledge of which of the two condition groups they are apart of during or after the study. The investigator will not have any knowledge of which of the two condition groups the participant is apart of during or after the study. Condition groups will be randomly assigned via the web-based portal used for recruitment, data collection, and testing.
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Order A
    Arm Type
    Active Comparator
    Arm Description
    Blue light treatment for 2 weeks, a 4-week washout period, and 2 weeks of placebo (amber) light treatment.
    Arm Title
    Treatment Order B
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo light treatment for 2 weeks, a 4-week washout period, and 2 weeks of blue light treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Blue light exposure
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Amber light exposure
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Suicidal Ideation: Depression
    Description
    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.
    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.
    Title
    Suicidal Ideation: Association with Death
    Description
    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.
    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.
    Title
    Suicidal Ideation: Hopelessness
    Description
    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.
    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.
    Title
    Suicidal Ideation: Suicidal Cognitions
    Description
    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.
    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.
    Title
    Suicidal Ideation: Loneliness
    Description
    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.
    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.
    Title
    Suicidal Ideation: Burdensomeness
    Description
    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.
    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.
    Title
    Suicidal Ideation: Resilience
    Description
    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.
    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.
    Secondary Outcome Measure Information:
    Title
    Total Sleep Time
    Description
    The total time individuals are asleep during intervention.
    Time Frame
    During both intervention periods, consisting of 14 days of daily measures each (28 days total).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ages 18-60 years English as primary language At least an 8th grade reading level Score ≥ 5 (i.e., mild depression or greater) on the Patient Health Questionnaire 9 (PHQ-9) Exclusion Criteria: Score in non-depressed range on Patient Health Questionnaire 9 (PHQ-9) (< 5) History of psychotic disorder or manic episodes Current or prior history of eye disease History of migraine headaches Current or prior history of sleep-related breathing disorders Self-reported use of sedative hypnotic sleep medications or melatonin supplements Self-reported use of prescription stimulants Self-reported excessive use of caffeine (i.e., > 500 mg per day) Plans to engage in nightshift work during the 8-week course of the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    William D Killgore, Ph.D.
    Phone
    (520) 621-0605
    Email
    killgore@arizona.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lindsey Hildebrand, MA
    Phone
    (520) 626-2203
    Email
    hildebrandll@arizona.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.
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