Clinical trial NCT04900675: Bright Light Intervention to Reduce Students' Stress
Official title: Effects of Bright Morning Light Exposure on Students' Stress, Mood, Anxiety, Sleep and, Circadian Rest-activity Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Physiological Stress
Sleep Disorders, Circadian Rhythm
Keywords: stress
light therapy
Lead sponsor: Universitaet Innsbruck
Sponsor class: OTHER
Collaborators: name: Bartenbach GmbH
First posted: 2021-05-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled, randomized trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: subjective stress level - baseline/post
timeFrame: Change from baseline PSS-10 sum score at the end of week 3
measure: subjective stress level - baseline/post
timeFrame: Change from baseline PSQ-20 sum score at the end of week 3
measure: subjective stress level - on weekdays
timeFrame: Change of daily PSQ-20 sum score at each weekday during the light intervention period up to 3 weeks
Secondary outcomes:
measure: anxiety
timeFrame: Change from baseline STAI-trait sum score at the end of week 3
measure: mood
timeFrame: Change from baseline CES-D sum score at the end of week 3
measure: sleep quality
timeFrame: Change from baseline global PSQI score at the end of week 3
measure: sleep quality - total sleep time
timeFrame: Change of TST at each night during the light intervention period up to 3 weeks
measure: sleep quality - sleep onset latency
timeFrame: change of SOL at each night during the light intervention period up to 3 weeks
measure: sleep quality - wake after sleep onset
timeFrame: change of WASO at each night during the light intervention period up to 3 weeks
measure: sleep quality - sleep efficiency
timeFrame: change of SE at each night during the light intervention period up to 3 weeks
measure: circadian rest/activity rhythm - interdaily stability
timeFrame: change of IV at each of the three light intervention weeks up to 3 weeks
measure: circadian rest/activity rhythm - intradaily variability
timeFrame: change of IS at each of the three light intervention weeks up to 3 weeks
measure: physiological stress reaction
timeFrame: Change from baseline hair cortisol level at the end of week 3
measure: adverse effects - short-term
timeFrame: day 5
measure: adverse effects - long-term
timeFrame: day 15
Other outcomes:
measure: resilience
timeFrame: Change from baseline RS-11 sum score at the end of week 3
measure: stress coping
timeFrame: Change from baseline multidimensional CISS scale at the end of week 3
measure: learning strategies
timeFrame: Change from baseline multidimensional LIST-K scale at the end of week 3
measure: psychological distress
timeFrame: Change from baseline BSI-18 overall score at the end of week 3
measure: somatic symptoms
timeFrame: Change from baseline SSS-8 sum score at the end of week 3
measure: satisfaction with light intervention - short-term
timeFrame: day 5
measure: satisfaction with light intervention - long-term
timeFrame: day 15
measure: daily mood state
timeFrame: 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
measure: weekly social rhythms
timeFrame: changes in SRM scores in week 1, week 2, and week 3
measure: anxiety state
timeFrame: changes from before the light intervention STAI-state sum score at the end of light intervention in week 1, week 2, and week 3
measure: cognitive performance
timeFrame: 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
measure: exam anxiety
timeFrame: changes of multidimensional PAF scale at week 1, week 2, and week 3
Locations:
city: Innsbruck
country: Austria
facility: University of Innsbruck
state: Tyrol
Study officials:
affiliation: University of Innsbruck
name: Markus Canazei, PhD
role: PRINCIPAL_INVESTIGATOR
References: