Depression Clinical Trial
Official title:
Bright Light: A Novel Treatment for Anxiety
| 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 |
| Verified date | April 2021 |
| Source | University of South Carolina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Chronobiology Lab, University of South Carolina | Columbia | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of South Carolina | Liteboook Company |
United States,
| 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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