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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01064700
Other study ID # HSA-3469
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2006
Est. completion date December 2007

Study information

Verified date April 2021
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Litebook Bright Light Box
Four weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.
Litebook inactivated negation ion generator (the placebo)
Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising

Locations

Country Name City State
United States Chronobiology Lab, University of South Carolina Columbia South Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of South Carolina Liteboook Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spielberger State Anxiety Inventory state anxiety questionnaire 5 weeks
Primary Hamilton Anxiety Hamilton Anxiety Questionnaire 5 weeks
Secondary Beck Depression Inventory self-report depression questionnaire 5 weeks
Secondary Pittsburgh Sleep Quality Inventory PSQI, a common sleep quality questionnaire 5 weeks
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