Bright Light: A Novel Treatment for Anxiety

NCT01064700 | Completed Phase 1

• 1 other identifier: HSA-3469
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Sleep

Keywords

Anxiety; Phototherapy; Psychic Anxiety

Outcome Measures

Primary Outcomes (2)

• Spielberger State Anxiety Inventory

  state anxiety questionnaire

  5 weeks

• Hamilton Anxiety

  Hamilton Anxiety Questionnaire

  5 weeks

Secondary Outcomes (2)

• Beck Depression Inventory

  5 weeks

• Pittsburgh Sleep Quality Inventory

  5 weeks

Study Arms (2)

Baseline

NO INTERVENTION

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 Intervention

EXPERIMENTAL

Randomized exposure to the 4-week experimental treatments.

Device: Litebook Bright Light Box; Device: Litebook inactivated negation ion generator (the placebo)

Interventions

Litebook Bright Light Box DEVICE

Four weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.

Also known as: Phototherapy

Experimental Intervention

Litebook inactivated negation ion generator (the placebo) DEVICE

Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising

Also known as: Placebo

Experimental Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Carolina: lead
• Liteboook Company: collaborator

Study Sites (1)

Chronobiology Lab, University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• 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.

  PMID: 21254315 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shawn D Youngstedt

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: October 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

US (1)