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Bright Light: A Novel Treatment for Anxiety

This study has been completed.
Sponsor:
Collaborator:
Liteboook Company
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01064700
First received: February 4, 2010
Last updated: February 5, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Anxiety
Depression
Sleep
 Device: Litebook Bright Light Box
Device: Litebook inactivated negation ion generator (the placebo)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bright Light: A Novel Treatment for Anxiety

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Spielberger State Anxiety Inventory [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Hamilton Anxiety [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Pittsburgh Sleep Quality Inventory [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
Other Name: Phototherapy
Device: 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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064700

Locations
United States, South Carolina
Chronobiology Lab, University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Liteboook Company
Investigators
Principal Investigator: Shawn D Youngstedt University of Southern California
  More Information

No publications provided by University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shawn Youngstedt, Associate Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT01064700     History of Changes
Other Study ID Numbers: HSA-3469
Study First Received: February 4, 2010
Last Updated: February 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
Anxiety
Phototherapy
Psychic Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 19, 2013