NCT04900675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

June 26, 2025

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

April 29, 2021

Last Update Submit

June 25, 2025

Conditions

Keywords

stresslight therapy

Outcome Measures

Primary Outcomes (3)

  • 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

    Change from baseline PSS-10 sum score at the end of week 3

  • 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

    Change from baseline PSQ-20 sum score at the end of week 3

  • 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

    Change of daily PSQ-20 sum score at each weekday during the light intervention period up to 3 weeks

Secondary Outcomes (12)

  • anxiety

    Change from baseline STAI-trait sum score at the end of week 3

  • mood

    Change from baseline CES-D sum score at the end of week 3

  • sleep quality

    Change from baseline global PSQI score at the end of week 3

  • sleep quality - total sleep time

    Change of TST at each night during the light intervention period up to 3 weeks

  • sleep quality - sleep onset latency

    change of SOL at each night during the light intervention period up to 3 weeks

  • +7 more secondary outcomes

Other Outcomes (12)

  • resilience

    Change from baseline RS-11 sum score at the end of week 3

  • stress coping

    Change from baseline multidimensional CISS scale at the end of week 3

  • learning strategies

    Change from baseline multidimensional LIST-K scale at the end of week 3

  • +9 more other outcomes

Study Arms (3)

bright white light intervention

EXPERIMENTAL

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

dim reddish light intervention

PLACEBO COMPARATOR

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

no light intervention

NO INTERVENTION

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

Interventions

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.

bright white light intervention

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

dim reddish light intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • students from the faculty of medicine, pharmacy, and law
  • major exam at least 5 weeks ahead
  • major depressive disorder (PHQ-9): Score \> 4
  • possession of smartphone and data plan

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Stress, PsychologicalSleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Officials

  • Markus Canazei, PhD

    University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: placebo-controlled, randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 25, 2021

Study Start

October 1, 2020

Primary Completion

March 31, 2024

Study Completion

October 31, 2024

Last Updated

June 26, 2025

Record last verified: 2024-12

Locations