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

Not Applicable

Completed

• Conditions: Stress
• Interventions: Device: Light therapy B via the Re-Timer®; Device: Light therapy C via the Re-Timer®; Device: Light therapy A via the Re-Timer®

• Registration Number: NCT04117347
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Study Start: 2020-01-24
• Primary Completion: 2023-03-08
• Study Completion: 2023-03-08
• Results First Submitted: 2024-03-01
• Results First Submitted QC: 2024-03-01
• Results First Posted: 2024-03-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light therapy B via the Re-Timer®	Light therapy B via the Re-Timer®	-30 minutes/day
Light therapy C via the Re-Timer®	Light therapy C via the Re-Timer®	-60 minutes/day
Light therapy A via the Re-Timer®	Light therapy A via the Re-Timer®	-15 minutes/day

Primary Outcome Measures

Name	Time	Method
Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal	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.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States