- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01064700
Bright Light: A Novel Treatment for Anxiety
The primary aim of this research was to examine the influence of bright light on anxiety in high-anxious young adults. In an acute exposure study, participants were randomly assigned to 45 min of either (1) bright light (3,000 lux) or (2) a placebo inactivated negative ion generator. Treatments were initiated ≤1 hr after awakening. At 10 min before and 30 min after the treatments, state anxiety, mood, and blood pressure were assessed.
Following the acute exposure study, participants performed a 5-week study. Following a a 1-week baseline, participants were randomly assigned to four weeks of daily exposure to either (1) bright light (45 min/day; 3,000 lux) or (2) placebo inactivated negative ion generator, which were initiated ≤1 hr after awakening. Before and after the experiment, clinical ratings were conducted with the Hamilton Anxiety Scale, the Hamilton Depression Scale, and the Clinical Global Impressions scale (CGI). Following baseline, and following each week of treatment, blood pressure, as well as questionnaires for state anxiety, depression, mood, sleep, and side effects were assessed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- Chronobiology Lab, University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having a level of trait anxiety [Spielberger State-Trait Anxiety Inventory (Form Y1)]{23642} that was ≥ the 75th percentile for their age (i.e., ≥ 46 and ≥ 44 for women and men, respectively)
Exclusion Criteria:
- Current treatment for anxiety or depression;
- History of bipolar disorder, mania, or psychotic disorders;
- History of winter depression, which might bias towards positive response to light;
- Hypertension;
- Ophthalmic abnormalities; and
- Usual exposure to high levels of light such that the intervention would add little to usual exposure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Baseline
1 week period, in which subjects followed usual schedule, though they were asked to maintain a fairly stable sleep schedule.
The baseline period was used for comparison with the experimental intervention.
|
|
Experimental: Experimental Intervention
Randomized exposure to the 4-week experimental treatments.
|
Four weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.
Other Names:
Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spielberger State Anxiety Inventory
Time Frame: 5 weeks
|
state anxiety questionnaire
|
5 weeks
|
Hamilton Anxiety
Time Frame: 5 weeks
|
Hamilton Anxiety Questionnaire
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory
Time Frame: 5 weeks
|
self-report depression questionnaire
|
5 weeks
|
Pittsburgh Sleep Quality Inventory
Time Frame: 5 weeks
|
PSQI, a common sleep quality questionnaire
|
5 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shawn D Youngstedt, University of Southern California
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSA-3469
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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