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Bright Light: A Novel Treatment for Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064700
First Posted: February 8, 2010
Last Update Posted: February 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Liteboook Company
Information provided by:
University of South Carolina
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bright Light: A Novel Treatment for Anxiety

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Spielberger State Anxiety Inventory [ Time Frame: 5 weeks ]
  • Hamilton Anxiety [ Time Frame: 5 weeks ]

Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 5 weeks ]
  • Pittsburgh Sleep Quality Inventory [ Time Frame: 5 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 4, 2010
First Posted: February 8, 2010
Last Update Posted: February 8, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders