- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06027944
Impact of Light on Mood
September 5, 2023 updated by: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- VA Palo Alto Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 18-60
- Mild depressive symptomatology
Exclusion Criteria:
- No depressive symptomatology
- Severe depressive symptomatology
- Active or unstable medical condition
- Diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Scene
High fidelity scene of nature emitted from a monitor
|
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)
|
Active Comparator: Scrambled scene
The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fast brain electrical activity
Time Frame: 15 minutes
|
Change in the beta power spectrum (12.5-30
Hz) of the electroencephalogram (brain waves, measured in microvolts)
|
15 minutes
|
Change in systolic blood pressure (SBP)
Time Frame: 15 minutes
|
Change in SBP (mm Hg) as measured by finger plethysmography
|
15 minutes
|
Change in heart rate variability (HRV)
Time Frame: 15 minutes
|
Shift in the ratio of the power of low frequency to high frequency components in heart rate variability
|
15 minutes
|
Change in sympathetic activity
Time Frame: 15 minutes
|
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
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
August 23, 2023
First Submitted That Met QC Criteria
September 5, 2023
First Posted (Actual)
September 7, 2023
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-71791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
After completion of data collection, cleaning, and publication, all experimental data will be made available via Dryad
IPD Sharing Time Frame
within three months of publication, no time limit
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Light exposure
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityNot yet recruitingSuicidal Ideation | Regulation, Emotion
-
Selcuk UniversityCompletedPost Operative Pain | Anxiety, DentalTurkey
-
University of BaselCompletedMuscle Strength | Endurance Performance | Reaction TimeSwitzerland
-
University of WyomingCompletedBinge Eating | Eating Disorder | Circadian DysregulationUnited States
-
University of BergenCompletedSleep | Circadian Rhythm Sleep Disorder, Delayed Sleep PhaseNorway
-
Access Business GroupUniversity of MichiganRecruitingUltraviolet Light BurnUnited States
-
Northwestern UniversityCompleted
-
VA Office of Research and DevelopmentCompletedInsomnia | Aging | Falls | BalanceUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)CompletedDepression | Quality of Life | Fatigue | Sleep | Hematopoietic Stem Cell Transplantation | Cognitive ImpairmentsUnited States
-
University of ArizonaActive, not recruiting