DepressionNCT06027944

Impact of Light on Mood

A study testing Light exposure in people with Depression, run by VA Palo Alto Health Care System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Depression
What is being tested?: Light exposure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2023to 30 Sep 2024
Phase: Interventional
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18-60
Mild depressive symptomatology

Who cannot join

No depressive symptomatology
Severe depressive symptomatology
Active or unstable medical condition
Diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health Care System
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: More Than Meets the Eye? The Impact of Light on Mood Regulation in Humans

The investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light.

Conditions: Depression
Being tested: Light exposure
Medical subject headings: Depression

What participants receive

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

Light exposureOther
Participants will be exposed to 15 minutes of each arm. They will be exposed twice and a randomized order (1/2/1/2 or 2/1/2/1)

Study groups in NCT06027944
Study group	Role	What they receive
Scene	Experimental	High fidelity scene of nature emitted from a monitor Receives: Other: Light exposure
Scrambled scene	Active comparator	The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor Receives: Other: Light exposure

What is being measured

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

Change in mood
Change in subjective mood as recored by the Positive and Negative Affect Schedule (PANAS). The PANAS ranges 10-50 on a positive mood scale (higher = more positive) and 10-50 on a negative mood scale (higher = more negative)
Measured: 15 minutes

Secondary outcomes (4)

Change in fast brain electrical activity
Change in the beta power spectrum (12.5-30 Hz) of the electroencephalogram (brain waves, measured in microvolts)
Measured: 15 minutes
Change in systolic blood pressure (SBP)
Change in SBP (mm Hg) as measured by finger plethysmography
Measured: 15 minutes
Change in heart rate variability (HRV)
Shift in the ratio of the power of low frequency to high frequency components in heart rate variability
Measured: 15 minutes
Change in sympathetic activity
Sympathetic activity will be imputed through the galvanic skin response (GSR). Change in skin conductance (the electrical activity on the skin) will be measured in microsiemens
Measured: 15 minutes

Timeline

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

1 Oct 202330 Sep 2024

First posted7 Sep 2023
Study start1 Oct 2023 (estimated)
Primary completion30 Sep 2024 (estimated)
Study completion30 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
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 N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06027944
Sponsor's protocol ID: IRB-71791
Status last verified: Sep 2023
First submitted: 23 Aug 2023
Last updated: 7 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After completion of data collection, cleaning, and publication, all experimental data will be made available via Dryad

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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: More Than Meets the Eye? The Impact of Light on Mood Regulation in Humans
ClinicalTrials.gov ID: NCT06027944
Acronym / sponsor ID: IRB-71791
Conditions: Depression
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: VA Palo Alto Health Care SystemUS federal agency
Collaborators: Stanford University
Study start: 1 Oct 2023 (estimated)
Primary completion: 30 Sep 2024 (estimated)
Study completion: 30 Sep 2024 (estimated)
First posted: 7 Sep 2023 (actual)
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.

The investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Scene	Experimental	Other: Light exposureHigh fidelity scene of nature emitted from a monitor
Scrambled scene	Active comparator	Other: Light exposureThe same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Aged 18-60
Mild depressive symptomatology

Key exclusion criteria (4 listed)

No depressive symptomatology
Severe depressive symptomatology
Active or unstable medical condition
Diabetes

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
Light exposureParticipants will be exposed to 15 minutes of each arm. They will be exposed twice and a randomized order (1/2/1/2 or 2/1/2/1)	Other	Scene, Scrambled scene

Primary outcome

Change in mood
Time frame: 15 minutes
Change in subjective mood as recored by the Positive and Negative Affect Schedule (PANAS). The PANAS ranges 10-50 on a positive mood scale (higher = more positive) and 10-50 on a negative mood scale (higher = more negative)

4 secondary outcomes

Change in fast brain electrical activity
Time frame: 15 minutes
Change in systolic blood pressure (SBP)
Time frame: 15 minutes
Change in heart rate variability (HRV)
Time frame: 15 minutes
Change in sympathetic activity
Time frame: 15 minutes

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Individual participant dataSharing planned: Yes. After completion of data collection, cleaning, and publication, all experimental data will be made available via Dryad

Related trials for Depression

Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
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Not yet recruitingObservational study
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Depression Disorder, Post Traumatic Stress Disorder PTSD
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Light exposure in people with Depression, run by VA Palo Alto Health Care System 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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.

Are results available for this study?

Results are not available in the source record.

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?

Change in mood (time frame: 15 minutes). 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 NCT06027944.

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 7 Sep 2023.