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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117347
• Other study ID #: HUM00161267
• Secondary ID: 1R61MH117157-01A
• Status: Completed
• Phase: N/A
• Start date: January 24, 2020
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Stress

Intervention

Device:
• Light therapy A via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
• Light therapy B via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
• Light therapy C via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal	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