NCT06027944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2023

Last Update Submit

September 5, 2023

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 minutes

Secondary Outcomes (4)

  • Change in fast brain electrical activity

    15 minutes

  • Change in systolic blood pressure (SBP)

    15 minutes

  • Change in heart rate variability (HRV)

    15 minutes

  • Change in sympathetic activity

    15 minutes

Study Arms (2)

Scene

EXPERIMENTAL

High fidelity scene of nature emitted from a monitor

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

Other: Light exposure

Interventions

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)

SceneScrambled scene

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-60
  • Mild depressive symptomatology

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 7, 2023

Study Start

October 1, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

After completion of data collection, cleaning, and publication, all experimental data will be made available via Dryad

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
within three months of publication, no time limit

Locations

US(1)