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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117347
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Burgess, 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.

Condition or disease Intervention/treatment Phase
Stress Device: Light therapy A via the Re-Timer® Device: Light therapy B via the Re-Timer® Device: Light therapy C via the Re-Timer® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will be blinded to study arm. The PI, study coordinator and research assistants will remain unblinded to perform safety assessments and provide feedback on intervention adherence. Blinded staff will wear buttons as an upfront visual cue to remind participants not to talk about their treatment.
Primary Purpose: Treatment
Official Title: Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

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 Name: 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 Name: 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 Name: Re-Timer®




Primary Outcome Measures :
  1. Change in amygdala reactivity as measured by whole-brain oxygen-level dependent functional magnetic resonance imaging (fMRI) signal [ Time Frame: Baseline and treatment week 2 and treatment week 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117347


Contacts
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Contact: Emily Spence 734-647-6657 morninglightstress@med.umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Helen Burgess, PhD         
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Helen Burgess University of Michigan

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Responsible Party: Helen Burgess, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT04117347    
Other Study ID Numbers: HUM00161267
1R61MH117157-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
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.

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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
Keywords provided by Helen Burgess, University of Michigan:
Circadian timing
Mood
Light