BLISS: Bright Light Intervention to Reduce Students' Stress

Sponsor
Universitaet Innsbruck (Other)
Overall Status
Recruiting
CT.gov ID
NCT04900675
Collaborator
Bartenbach GmbH (Other)
100
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2
19.9
5

Study Details

Study Description

Brief Summary

Increased stress levels are a significant problem for many students and represent a risk factor for impaired mental and physical health as well as academic performance. Stress levels are particularly high during the preparation phase for major exams.

There is good evidence that light therapy is an effective treatment option to improve mood in affective disorders.

The present study aims at investigating the psychophysiological effects of a 3-week morning bright light exposure in reducing stress and stress-related problems in students preparing for major exams.

Condition or Disease Intervention/Treatment Phase
  • Other: Bright light intervention
  • Other: Reddish placebo light
N/A

Detailed Description

Increased students' stress represents a significant risk factor for impaired mental and physical health as well as academic performance. The World Mental Health Survey (WHO) reports a 12-month prevalence of mental illness of 20.3% among students, with anxiety disorders (14.7%), affective disorders (9.9%), and substance abuse (6.7%) being particularly prominent. Moreover, six out of 10 students suffer from impaired sleep quality.

Offering an effective treatment for stress-related symptoms in students is a challenge. In situations of intense stress, conventional methods such as relaxation and mindfulness-based programs often fail because of poor prior practice. Only a few students apply cognitive behavioral interventions. Although medication might decrease stress symptoms within days, the side effects of drugs cannot be ignored. Therefore, there is a need for effective and efficient treatment of acute stress symptoms in students.

Bright light therapy is an effective treatment for several mental disorders, e.g. affective disorders and sleep disorders. There is some evidence, that exposure to bright light may even reduce stress in patients with burnout symptoms. Thus, exposure to bright light may be a promising new option to reduce academic stress and improve mood and sleep parameters.

In the present study, a large-area desk lamp, which emits diffuse light and is controllable in its luminance and correlated color temperature is used. Study participants are randomly assigned to one of two study arms: exposure to polychromatic light of (a) 5,000 lux and 5,300 Kelvin or (b) 50 lux and 2,200 Kelvin. Light exposure takes place in two winter periods.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
placebo-controlled, randomized trialplacebo-controlled, randomized trial
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
At inclusion, it is only explained to the test persons that the influence of regular exposure to light in the morning is being investigated. The control light condition comprises dim, reddish light. The reddish color tone in this light intervention should mask allocation to the study arm. Data analysis is carried out by a person in the project team who is blinded to the light interventions.
Primary Purpose:
Treatment
Official Title:
Effects of Bright Morning Light Exposure on Students' Stress, Mood, Anxiety, Sleep and, Circadian Rest-activity Cycle
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: bright white light intervention

exposure to 5,000 lux with polychromatic white light with 5,300 Kelvin at eye level; light exposure starts immediately after awakening; light exposure takes place on weekdays (Monday till Friday) over a period of 3 weeks

Other: Bright light intervention
Exposure with 5,000 lux at eye level for one hour and a Correlated Color Temperature of 5,300 Kelvin every morning for three weeks.

Placebo Comparator: dim reddish light intervention

exposure to 50 lux with polychromatic reddish light with 2,200 Kelvin at eye level; light exposure starts immediately after awakening; light exposure takes place on weekdays (Monday till Friday) over a period of 3 weeks

Other: Reddish placebo light
Exposure with 50 lux at eye level for one hour and a Correlated Color Temperature of 2,200 Kelvin every morning for three weeks.

Outcome Measures

Primary Outcome Measures

  1. subjective stress level - baseline/post [Change from baseline PSS-10 sum score at the end of week 3]

    Perceived Stress Scale (PSS-10); scale: PSS-10 sum score; range:0 - 40; higher scores mean a higher subjective stress level

  2. subjective stress level - baseline/post [Change from baseline PSQ-20 sum score at the end of week 3]

    Perceived Stress Questionnaire (PSQ-20); scale: PSQ-20 sum score; range: 20 - 80; higher scores mean a higher subjective stress level

  3. subjective stress level - on weekdays [Change of daily PSQ-20 sum score at each weekday during the light intervention period up to 3 weeks]

    Perceived Stress Questionnaire (PSQ-20); scale: PSQ-20 sum score; range: 20 - 80; higher scores mean a higher subjective stress level

Secondary Outcome Measures

  1. anxiety [Change from baseline STAI-trait sum score at the end of week 3]

    State-Trait Anxiety Inventory (STAI - form Y) - 20 trait items; scale: STAI-trait sum score; range: 20 - 80; higher scores mean a higher subjective anxiety level

  2. mood [Change from baseline CES-D sum score at the end of week 3]

    Center for Epidemiologic Studies Depression Scale (CES--D); scale: CES-D sum score; range: 0 - 60; higher scores mean a higher subjective depression level

  3. sleep quality [Change from baseline global PSQI score at the end of week 3]

    Pittsburgh Sleep Quality Index (PSQI); scale: global PSQI score; range: 0 - 21; higher scores mean a lower subjective sleep quality

  4. sleep quality - total sleep time [Change of TST at each night during the light intervention period up to 3 weeks]

    Wrist actimetry to measure daily total sleep time (TST); scale: sleep duration; range: >0 (minutes); higher TST means longer sleep period

  5. sleep quality - sleep onset latency [change of SOL at each night during the light intervention period up to 3 weeks]

    Wrist actimetry to measure daily sleep onset latency (SOL); scale: duration to fall asleep; range: >0 (minutes); higher SOL means longer period to fall asleep

  6. sleep quality - wake after sleep onset [change of WASO at each night during the light intervention period up to 3 weeks]

    Wrist actimetry to measure daily wake after sleep onset (WASO); scale: duration of being awake during sleep period; range: greater than or equal to 0 (minutes); higher WASO means longer wake periods after sleep onset

  7. sleep quality - sleep efficiency [change of SE at each night during the light intervention period up to 3 weeks]

    Wrist actimetry to measure daily sleep efficiency (SE); scale: percentage; range: 0 - 100; higher SE means a higher undisturbed sleep

  8. circadian rest/activity rhythm - interdaily stability [change of IV at each of the three light intervention weeks up to 3 weeks]

    Circadian rest-activity cycle parameter interdaily stability (IS) derived from weekly wrist actimetry data; scale: real number; range: 0 -1; higher IS means a higher stability in daily rest-activity cycles

  9. circadian rest/activity rhythm - intradaily variability [change of IS at each of the three light intervention weeks up to 3 weeks]

    Circadian rest-activity cycle parameter intradaily variability (IV) derived from averaged wrist actimetry data over a period of 1 week; scale: real number; range: 0 - 2; higher IV means a higher variability in 24-h rest-activity cycle

  10. physiological stress reaction [Change from baseline hair cortisol level at the end of week 3]

    cortisol level measured from hair sample; scale: real number (pg/mg); range: >0; higher hair cortisol level means higher physiological stress

  11. adverse effects - short-term [day 5]

    astenopic complaints measured with 12 items; scale: sum score; range: 10 - 60; higher sum score means more astenopic complaints

  12. adverse effects - long-term [day 15]

    astenopic complaints scale measured with 12 items: sum score; range: 10 - 60; higher sum score means more astenopic complaints

Other Outcome Measures

  1. resilience [Change from baseline RS-11 sum score at the end of week 3]

    Resilience Scale (RS-11); scale: RS-11 sum score; range: 11 - 77; higher RS-11 sum score means more perceived resilience

  2. stress coping [Change from baseline multidimensional CISS scale at the end of week 3]

    Coping Inventory for Stressful Situations (CISS) - 24 items; three-dimensional CISS scale: (a) task-oriented coping; (b) emotion-oriented coping, and (c) avoidance-oriented coping; range for each dimension: 8 - 40; higher score in each dimension means higher preference for particular stress coping style

  3. learning strategies [Change from baseline multidimensional LIST-K scale at the end of week 3]

    Learning Strategies of University Students (LIST-K) - 36 items; multidimensional LIST-K scale: 13 subscales; range for each dimension: 3 - 15; higher score in each dimension means higher preference for particular learning strategy

  4. psychological distress [Change from baseline BSI-18 overall score at the end of week 3]

    Brief Symptom Inventory (BSI-18); scale: BSI-18 sum score; range: 18 - 90; higher BSI-18 sum score means higher psychological distress

  5. somatic symptoms [Change from baseline SSS-8 sum score at the end of week 3]

    The somatic symptom scale (SSS-8); scale: SSS-8 sum score; range: 0 - 32; higher SSS-8 sum score means higher somatic complaints

  6. satisfaction with light intervention - short-term [day 5]

    2 items: (a) recommendation of light intervention to a friend and (b) follow-up usage of light intervention for own purposes; scale: binary score ('yes', 'no'); range: 0 - 1; higher binary scores indicate recommendation and follow-up usage of the light intervention

  7. satisfaction with light intervention - long-term [day 15]

    2 items: (a) recommendation of light intervention to a friend and (b) follow-up usage of light intervention for own purposes; scale: binary score ('yes', 'no'); range: 0 - 1; higher binary scores indicate recommendation and follow-up usage of the light intervention

  8. daily mood state [changes from before the light intervention of the two-dimensional PANAS scale at the end of light intervention at each weekday during the light intervention period up to 3 weeks]

    Positive and Negative Affect Schedule (PANAS); two-dimensional PANAS scale: sum score for positive and negative mood state; range for each dimension: 10 - 50; higher PANAS scores mean higher positive and negative mood state, respectively

  9. weekly social rhythms [changes in SRM scores in week 1, week 2, and week 3]

    The Social Rhythm Metric (SRM) measures the regularity in the occurance of 17 daily events; scale: SRM score; range: 0 - 7; higher SRM scores mean more regular occurance of daily events

  10. anxiety state [changes from before the light intervention STAI-state sum score at the end of light intervention in week 1, week 2, and week 3]

    State-Trait Anxiety Inventory (STAI - form Y) - 20 state items; scale: STAI-state sum score; range: 20 - 80; higher scores mean a higher subjective current anxiety level

  11. cognitive performance [changes from before the light intervention NLT number of correct answers at the end of light intervention in week 1, week 2, and week 3]

    The Number Letter Task (NLT) measures task switching performance; scale: number of correct answers; range: integer greater than or equal to 0; higher NLT scores means a better task switching performance

  12. exam anxiety [changes of multidimensional PAF scale at week 1, week 2, and week 3]

    German Test Anxiety Inventory (PAF); four-dimensional PAF scale: (a) excitement, (b) concern, (c) interference, and (d) lack of confidence; range for each dimension: 5 - 20; higher scale means higher test anxiety in the corresponding dimension

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • students from the faculty of medicine, pharmacy, and law

  • major exam at least 5 weeks ahead

  • possession of smartphone and data plan

Exclusion Criteria:
  • major depressive disorder (PHQ-9): Score > 4

  • suicidal ideation (BDI, Item i): Rating > 1

  • seasonal affective disorder (PIDS-A): Score > 11

  • taking medication which increases photo-sensitivity

  • taking medication to increase cognitive performance

  • starting or changing pharmacotherapy for affective disorders and anxiety disorders within the last two weeks

  • changing of all kinds of medication within the last two weeks

  • headache (PHQ-D, Item f): Rating "severly impaired"

  • increased light sensitivity: Item "Wearing sunglasses outside on sunny days" is answered with 'often' or 'very often'

  • currently undergoing psychotherapeutic treatment

  • the presence of an eye disease for which light therapy is contraindicated

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Innsbruck Innsbruck Tyrol Austria 6020

Sponsors and Collaborators

  • Universitaet Innsbruck
  • Bartenbach GmbH

Investigators

  • Principal Investigator: Markus Canazei, PhD, University of Innsbruck

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Markus Canazei, Principal Investigator, Universitaet Innsbruck
ClinicalTrials.gov Identifier:
NCT04900675
Other Study ID Numbers:
  • 878649
First Posted:
May 25, 2021
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Markus Canazei, Principal Investigator, Universitaet Innsbruck
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2021