Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity

December 10, 2024 updated by: Helen Burgess, University of Michigan
The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Brain emotional processing was determined with the Emotional Faces Assessment Task (EFAT). In this task, participants view a trio of faces and match one of the two faces (bottom) that expresses the same emotion as the target face (top). The faces display one of five expressions (angry, happy, fearful, sad, neutral) and the other (incongruent) probe face always displays a neutral (or happy if the target is neutral) expression. The paradigm consists of 20 face trials per expression and 20 shape trials, presented in pseudorandomized order, separated by a 3-7 sec intertrial blank screen with fixation cross.

Study Type

Interventional

Enrollment (Actual)

50

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meets criteria for traumatic stress
  • Normal or corrected to normal vision
  • Right-handed
  • Fluency in English
  • Physically able to travel for study visit attendance

Exclusion Criteria:

  • Significant chronic uncontrolled disease (e.g. uncontrolled diabetes, advanced liver disease, cancer, etc.)
  • Severe hearing problem
  • Intellectual disability or serious cognitive impairment
  • Inability to tolerate enclosed spaces (e.g. the MRI machine)
  • Ferrous-containing metals within the body
  • Pregnant, trying to get pregnant, or breastfeeding
  • Epilepsy
  • Other research participation
  • Frequent number of special events during study period (weddings, concerts, exams, etc.)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light therapy A via the Re-Timer®
-15 minutes/day
Device: Light therapy A via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Other Names:
  • Re-Timer®
Experimental: Light therapy B via the Re-Timer®
-30 minutes/day
Device: Light therapy B via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Other Names:
  • Re-Timer®
Experimental: Light therapy C via the Re-Timer®
-60 minutes/day
Device: Light therapy C via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Other Names:
  • Re-Timer®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal
Time Frame: Baseline and treatment week 2 and treatment week 4
Participants completed the Emotional Faces Assessment Task (EFAT) during the fMRI scan. The average blood-oxygen-level-dependent (BOLD) signal change between the display of negative faces versus display of shapes was derived for the left and right amygdala separately. Higher levels indicate greater amygdala reactivity to negative faces versus display of shapes.
Baseline and treatment week 2 and treatment week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Helen Burgess, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

January 24, 2020

Primary Completion (Actual)

March 8, 2023

Study Completion (Actual)

March 8, 2023

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00161267
  • 1R61MH117157-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff. That includes that identified research information will be entered into the National Institute of Mental Health's Database for Clinical Trials related to Mental Illness (NDCT)

IPD Sharing Time Frame

After scientific papers are accepted for publication and the data will be available for 7 years after study completion.

IPD Sharing Access Criteria

Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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

product manufactured in and exported from the U.S.

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.

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