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Impact of Light on Mood

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light exposure
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 18-60 Mild depressive symptomatology Exclusion Criteria: No depressive symptomatology Severe depressive symptomatology Active or unstable medical condition Diabetes

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scene

Scrambled scene

Arm Description

High fidelity scene of nature emitted from a monitor

The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in fast brain electrical activity
Change in the beta power spectrum (12.5-30 Hz) of the electroencephalogram (brain waves, measured in microvolts)
Change in systolic blood pressure (SBP)
Change in SBP (mm Hg) as measured by finger plethysmography
Change in heart rate variability (HRV)
Shift in the ratio of the power of low frequency to high frequency components in heart rate variability
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

Full Information

First Posted
August 23, 2023
Last Updated
September 5, 2023
Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT06027944
Brief Title
Impact of Light on Mood
Official Title
More Than Meets the Eye? The Impact of Light on Mood Regulation in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scene
Arm Type
Experimental
Arm Description
High fidelity scene of nature emitted from a monitor
Arm Title
Scrambled scene
Arm Type
Active Comparator
Arm Description
The same pixels that are used to create the scene in the alternate arm will be randomly scrambled on the monitor
Intervention Type
Other
Intervention Name(s)
Light exposure
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in mood
Description
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)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Change in fast brain electrical activity
Description
Change in the beta power spectrum (12.5-30 Hz) of the electroencephalogram (brain waves, measured in microvolts)
Time Frame
15 minutes
Title
Change in systolic blood pressure (SBP)
Description
Change in SBP (mm Hg) as measured by finger plethysmography
Time Frame
15 minutes
Title
Change in heart rate variability (HRV)
Description
Shift in the ratio of the power of low frequency to high frequency components in heart rate variability
Time Frame
15 minutes
Title
Change in sympathetic activity
Description
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
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18-60 Mild depressive symptomatology Exclusion Criteria: No depressive symptomatology Severe depressive symptomatology Active or unstable medical condition Diabetes
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Impact of Light on Mood

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