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Bright Light: A Novel Treatment for Anxiety

Primary Purpose

Anxiety, Depression, Sleep

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Litebook Bright Light Box
Litebook inactivated negation ion generator (the placebo)
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Phototherapy, Psychic Anxiety

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chronobiology Lab, University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Baseline

Experimental Intervention

Arm Description

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.

Randomized exposure to the 4-week experimental treatments.

Outcomes

Primary Outcome Measures

Spielberger State Anxiety Inventory
state anxiety questionnaire
Hamilton Anxiety
Hamilton Anxiety Questionnaire

Secondary Outcome Measures

Beck Depression Inventory
self-report depression questionnaire
Pittsburgh Sleep Quality Inventory
PSQI, a common sleep quality questionnaire

Full Information

First Posted
February 4, 2010
Last Updated
April 26, 2021
Sponsor
University of South Carolina
Collaborators
Liteboook Company
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1. Study Identification

Unique Protocol Identification Number
NCT01064700
Brief Title
Bright Light: A Novel Treatment for Anxiety
Official Title
Bright Light: A Novel Treatment for Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Liteboook Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Sleep
Keywords
Anxiety, Phototherapy, Psychic Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental Intervention
Arm Type
Experimental
Arm Description
Randomized exposure to the 4-week experimental treatments.
Intervention Type
Device
Intervention Name(s)
Litebook Bright Light Box
Other Intervention Name(s)
Phototherapy
Intervention Description
Four weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.
Intervention Type
Device
Intervention Name(s)
Litebook inactivated negation ion generator (the placebo)
Other Intervention Name(s)
Placebo
Intervention Description
Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising
Primary Outcome Measure Information:
Title
Spielberger State Anxiety Inventory
Description
state anxiety questionnaire
Time Frame
5 weeks
Title
Hamilton Anxiety
Description
Hamilton Anxiety Questionnaire
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
self-report depression questionnaire
Time Frame
5 weeks
Title
Pittsburgh Sleep Quality Inventory
Description
PSQI, a common sleep quality questionnaire
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D Youngstedt
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chronobiology Lab, University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21254315
Citation
Youngstedt SD, Kline CE, Ginsberg JP, Zielinski MR, Hardin JW. Bright light treatment for high-anxious young adults: a randomized controlled pilot study. Depress Anxiety. 2011 Apr;28(4):324-32. doi: 10.1002/da.20784. Epub 2011 Jan 19.
Results Reference
derived

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Bright Light: A Novel Treatment for Anxiety

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