Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
2 other identifiers
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedStudy Start
First participant enrolled
January 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2023
CompletedResults Posted
Study results publicly available
March 26, 2024
CompletedDecember 27, 2024
December 1, 2024
3.1 years
October 3, 2019
March 1, 2024
December 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Light therapy A via the Re-Timer®
EXPERIMENTAL-15 minutes/day
Light therapy B via the Re-Timer®
EXPERIMENTAL-30 minutes/day
Light therapy C via the Re-Timer®
EXPERIMENTAL-60 minutes/day
Interventions
Subjects will conduct light treatment in the mornings at home.
Subjects will conduct light treatment in the mornings at home.
Subjects will conduct light treatment in the mornings at home.
Eligibility Criteria
You may qualify if:
- Meets criteria for traumatic stress
- Normal or corrected to normal vision
- Right-handed
- Fluency in English
- Physically able to travel for study visit attendance
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
The University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Burgess HJ, Rizvydeen M, Huizenga B, Prasad M, Bahl S, Duval ER, Kim HM, Phan KL, Liberzon I, Abelson J, Klumpp H, Horwitz A, Mooney A, Raglan GB, Zalta AK. A 4-week morning light treatment reduces amygdala reactivity and clinical symptoms in adults with traumatic stress. Psychiatry Res. 2024 Dec;342:116209. doi: 10.1016/j.psychres.2024.116209. Epub 2024 Sep 21.
PMID: 39316998RESULT
Related Links
Results Point of Contact
- Title
- Dr. Helen Burgess
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Burgess
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 7, 2019
Study Start
January 24, 2020
Primary Completion
March 8, 2023
Study Completion
March 8, 2023
Last Updated
December 27, 2024
Results First Posted
March 26, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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)