Bright Light: A Novel Treatment for Anxiety

NCT ID: NCT01064700

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Intervention

Randomized exposure to the 4-week experimental treatments.

Group Type EXPERIMENTAL

Litebook Bright Light Box

Intervention Type DEVICE

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

Litebook inactivated negation ion generator (the placebo)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Phototherapy Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Liteboook Company

UNKNOWN

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shawn Youngstedt

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shawn D Youngstedt

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chronobiology Lab, University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21254315 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSA-3469

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Light Sensitization Study
NCT01327040 COMPLETED NA
Green Light Effect on Sleep
NCT04828473 UNKNOWN NA