AnxietyPhase 1NCT01064700

Bright Light: A Novel Treatment for Anxiety

A Phase 1 study testing Litebook Bright Light Box in people with Anxiety and Depression, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety, Depression, Sleep
What is being tested?: Litebook Bright Light Box
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Dec 2007
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Chronobiology Lab, University of South Carolina
Columbia, South Carolina, 29208

Other trials in United States

About this study

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
Being tested: Litebook Bright Light Box, Litebook inactivated negation ion generator (the placebo)
Keywords: Anxiety, Phototherapy, Psychic Anxiety
Medical subject headings: Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Litebook Bright Light BoxDevice
Also called Phototherapy
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)Device
Also called Placebo
Four weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising

Study groups in NCT01064700
Study group	Role	What they receive
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. Receives: Device: Litebook Bright Light Box; Device: Litebook inactivated negation ion generator (the placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Spielberger State Anxiety Inventory
state anxiety questionnaire
Measured: 5 weeks
Hamilton Anxiety
Hamilton Anxiety Questionnaire
Measured: 5 weeks

Secondary outcomes (2)

Beck Depression Inventory
self-report depression questionnaire
Measured: 5 weeks
Pittsburgh Sleep Quality Inventory
PSQI, a common sleep quality questionnaire
Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Dec 2007

First posted8 Feb 2010 (estimated)
Study startOct 2006
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01064700
Sponsor's protocol ID: HSA-3469
Status last verified: Apr 2021
First submitted: 4 Feb 2010
Last updated: 28 Apr 2021
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 21254315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bright Light: A Novel Treatment for Anxiety
ClinicalTrials.gov ID: NCT01064700
Acronym / sponsor ID: HSA-3469
Conditions: Anxiety, Depression, Sleep
Keywords: Anxiety, Phototherapy, Psychic Anxiety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: University of South CarolinaUniversity, hospital or other
Collaborators: Liteboook Company
Study start: Oct 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 8 Feb 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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	Device: Litebook Bright Light Box, Device: Litebook inactivated negation ion generator (the placebo)Randomized exposure to the 4-week experimental treatments.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Litebook Bright Light BoxAlso: PhototherapyFour weeks of daily exposure to bright light (3,000 lux) for 45 min/day, beginning within 60 min of arising.	Device	Experimental Intervention
Litebook inactivated negation ion generator (the placebo)Also: PlaceboFour weeks of daily exposure to inactivated negative ion generator for 45 min/day, beginning within 60 min of arising	Device	Experimental Intervention

Primary outcome

Spielberger State Anxiety Inventory
Time frame: 5 weeks
state anxiety questionnaire
Hamilton Anxiety
Time frame: 5 weeks
Hamilton Anxiety Questionnaire

2 secondary outcomes

Beck Depression Inventory
Time frame: 5 weeks
Pittsburgh Sleep Quality Inventory
Time frame: 5 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Derived from this study: PubMed 21254315Youngstedt 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shawn D Youngstedt principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Litebook Bright Light Box in people with Anxiety and Depression, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spielberger State Anxiety Inventory (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.