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Completed

NCT Number: NCT04117347

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

The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.

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Key information

Conditions

Stress

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Light therapy A via the Re-Timer®

Device

Subjects will conduct light treatment in the mornings at home.

Other names: Re-Timer®

Light therapy B via the Re-Timer®

Device

Subjects will conduct light treatment in the mornings at home.

Other names: Re-Timer®

Light therapy C via the Re-Timer®

Device

Subjects will conduct light treatment in the mornings at home.

Other names: Re-Timer®

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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