search
Back to results

Bright Light Intervention to Reduce Students' Stress (BLISS)

Primary Purpose

Psychological Stress, Physiological Stress, Sleep Disorders, Circadian Rhythm

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Bright light intervention
Reddish placebo light
Sponsored by
Universitaet Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Stress focused on measuring stress, light therapy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

bright white light intervention

dim reddish light intervention

no light intervention

Arm Description

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

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

no light intervention takes place in the morning; the study participants follow their natural rhythm of life

Outcomes

Primary Outcome Measures

subjective stress level - baseline/post
Perceived Stress Scale (PSS-10); scale: PSS-10 sum score; range:0 - 40; higher scores mean a higher subjective stress level
subjective stress level - baseline/post
Perceived Stress Questionnaire (PSQ-20); scale: PSQ-20 sum score; range: 20 - 80; higher scores mean a higher subjective stress level
subjective stress level - on weekdays
Perceived Stress Questionnaire (PSQ-20); scale: PSQ-20 sum score; range: 20 - 80; higher scores mean a higher subjective stress level

Secondary Outcome Measures

anxiety
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
mood
Center for Epidemiologic Studies Depression Scale (CES--D); scale: CES-D sum score; range: 0 - 60; higher scores mean a higher subjective depression level
sleep quality
Pittsburgh Sleep Quality Index (PSQI); scale: global PSQI score; range: 0 - 21; higher scores mean a lower subjective sleep quality
sleep quality - total sleep time
Wrist actimetry to measure daily total sleep time (TST); scale: sleep duration; range: >0 (minutes); higher TST means longer sleep period
sleep quality - sleep onset latency
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
sleep quality - wake after sleep onset
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
sleep quality - sleep efficiency
Wrist actimetry to measure daily sleep efficiency (SE); scale: percentage; range: 0 - 100; higher SE means a higher undisturbed sleep
circadian rest/activity rhythm - interdaily stability
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
circadian rest/activity rhythm - intradaily variability
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
physiological stress reaction
cortisol level measured from hair sample; scale: real number (pg/mg); range: >0; higher hair cortisol level means higher physiological stress
adverse effects - short-term
astenopic complaints measured with 12 items; scale: sum score; range: 10 - 60; higher sum score means more astenopic complaints
adverse effects - long-term
astenopic complaints scale measured with 12 items: sum score; range: 10 - 60; higher sum score means more astenopic complaints

Full Information

First Posted
April 29, 2021
Last Updated
September 14, 2023
Sponsor
Universitaet Innsbruck
Collaborators
Bartenbach GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT04900675
Brief Title
Bright Light Intervention to Reduce Students' Stress
Acronym
BLISS
Official Title
Effects of Bright Morning Light Exposure on Students' Stress, Mood, Anxiety, Sleep and, Circadian Rest-activity Cycle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaet Innsbruck
Collaborators
Bartenbach GmbH

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
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.
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 three study arms: (i) exposure to polychromatic light of 5,000 lux and 5,300 Kelvin, (ii) exposure to polychromatic light of 50 lux and 2,200 Kelvin, or (iii) no light intervention. Data collection takes place in winter periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Physiological Stress, Sleep Disorders, Circadian Rhythm
Keywords
stress, light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
placebo-controlled, randomized trial
Masking
ParticipantOutcomes Assessor
Masking Description
After randomisation to the two light intervention study arms, 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. A no-light intervention group (study arm 3) will be established as an additional control condition. Data analysis will be carried out by a member of the project team who is blinded to study arm allocation.
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bright white light intervention
Arm Type
Experimental
Arm Description
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
Arm Title
dim reddish light intervention
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
no light intervention
Arm Type
No Intervention
Arm Description
no light intervention takes place in the morning; the study participants follow their natural rhythm of life
Intervention Type
Other
Intervention Name(s)
Bright light intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Reddish placebo light
Intervention Description
Exposure with 50 lux at eye level for one hour and a Correlated Color Temperature of 2,200 Kelvin every morning for three weeks.
Primary Outcome Measure Information:
Title
subjective stress level - baseline/post
Description
Perceived Stress Scale (PSS-10); scale: PSS-10 sum score; range:0 - 40; higher scores mean a higher subjective stress level
Time Frame
Change from baseline PSS-10 sum score at the end of week 3
Title
subjective stress level - baseline/post
Description
Perceived Stress Questionnaire (PSQ-20); scale: PSQ-20 sum score; range: 20 - 80; higher scores mean a higher subjective stress level
Time Frame
Change from baseline PSQ-20 sum score at the end of week 3
Title
subjective stress level - on weekdays
Description
Perceived Stress Questionnaire (PSQ-20); scale: PSQ-20 sum score; range: 20 - 80; higher scores mean a higher subjective stress level
Time Frame
Change of daily PSQ-20 sum score at each weekday during the light intervention period up to 3 weeks
Secondary Outcome Measure Information:
Title
anxiety
Description
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
Time Frame
Change from baseline STAI-trait sum score at the end of week 3
Title
mood
Description
Center for Epidemiologic Studies Depression Scale (CES--D); scale: CES-D sum score; range: 0 - 60; higher scores mean a higher subjective depression level
Time Frame
Change from baseline CES-D sum score at the end of week 3
Title
sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI); scale: global PSQI score; range: 0 - 21; higher scores mean a lower subjective sleep quality
Time Frame
Change from baseline global PSQI score at the end of week 3
Title
sleep quality - total sleep time
Description
Wrist actimetry to measure daily total sleep time (TST); scale: sleep duration; range: >0 (minutes); higher TST means longer sleep period
Time Frame
Change of TST at each night during the light intervention period up to 3 weeks
Title
sleep quality - sleep onset latency
Description
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
Time Frame
change of SOL at each night during the light intervention period up to 3 weeks
Title
sleep quality - wake after sleep onset
Description
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
Time Frame
change of WASO at each night during the light intervention period up to 3 weeks
Title
sleep quality - sleep efficiency
Description
Wrist actimetry to measure daily sleep efficiency (SE); scale: percentage; range: 0 - 100; higher SE means a higher undisturbed sleep
Time Frame
change of SE at each night during the light intervention period up to 3 weeks
Title
circadian rest/activity rhythm - interdaily stability
Description
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
Time Frame
change of IV at each of the three light intervention weeks up to 3 weeks
Title
circadian rest/activity rhythm - intradaily variability
Description
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
Time Frame
change of IS at each of the three light intervention weeks up to 3 weeks
Title
physiological stress reaction
Description
cortisol level measured from hair sample; scale: real number (pg/mg); range: >0; higher hair cortisol level means higher physiological stress
Time Frame
Change from baseline hair cortisol level at the end of week 3
Title
adverse effects - short-term
Description
astenopic complaints measured with 12 items; scale: sum score; range: 10 - 60; higher sum score means more astenopic complaints
Time Frame
day 5
Title
adverse effects - long-term
Description
astenopic complaints scale measured with 12 items: sum score; range: 10 - 60; higher sum score means more astenopic complaints
Time Frame
day 15
Other Pre-specified Outcome Measures:
Title
resilience
Description
Resilience Scale (RS-11); scale: RS-11 sum score; range: 11 - 77; higher RS-11 sum score means more perceived resilience
Time Frame
Change from baseline RS-11 sum score at the end of week 3
Title
stress coping
Description
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
Time Frame
Change from baseline multidimensional CISS scale at the end of week 3
Title
learning strategies
Description
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
Time Frame
Change from baseline multidimensional LIST-K scale at the end of week 3
Title
psychological distress
Description
Brief Symptom Inventory (BSI-18); scale: BSI-18 sum score; range: 18 - 90; higher BSI-18 sum score means higher psychological distress
Time Frame
Change from baseline BSI-18 overall score at the end of week 3
Title
somatic symptoms
Description
The somatic symptom scale (SSS-8); scale: SSS-8 sum score; range: 0 - 32; higher SSS-8 sum score means higher somatic complaints
Time Frame
Change from baseline SSS-8 sum score at the end of week 3
Title
satisfaction with light intervention - short-term
Description
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
Time Frame
day 5
Title
satisfaction with light intervention - long-term
Description
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
Time Frame
day 15
Title
daily mood state
Description
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
Time Frame
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
Title
weekly social rhythms
Description
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
Time Frame
changes in SRM scores in week 1, week 2, and week 3
Title
anxiety state
Description
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
Time Frame
changes from before the light intervention STAI-state sum score at the end of light intervention in week 1, week 2, and week 3
Title
cognitive performance
Description
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
Time Frame
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
Title
exam anxiety
Description
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
Time Frame
changes of multidimensional PAF scale at week 1, week 2, and week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Canazei, PhD
Phone
0043-512-507
Ext
56060
Email
markus.canazei@uibk.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Canazei, PhD
Organizational Affiliation
University of Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Canazei, PhD
Phone
0043-512-507
Ext
56060
Email
markus.canazei@uibk.ac.at
First Name & Middle Initial & Last Name & Degree
Inge Pfanzelt
Phone
0043-512-507
Ext
56005
Email
Inge.Pfanzelt@uibk.ac.at

12. IPD Sharing Statement

Learn more about this trial

Bright Light Intervention to Reduce Students' Stress

We'll reach out to this number within 24 hrs