StressNCT04117347

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

A study testing Light therapy A via the Re-Timer®, Light therapy B via the Re-Timer® and Light therapy C via the Re-Timer® in people with Stress, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Stress
What is being tested?: Light therapy A via the Re-Timer®, Light therapy B via the Re-Timer® and Light therapy C via the Re-Timer®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2020to 8 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Meets criteria for traumatic stress
Normal or corrected to normal vision
Right-handed
Fluency in English
Physically able to travel for study visit attendance

Who cannot join

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

Show all 9Show fewer

Epilepsy
Other research participation
Frequent number of special events during study period (weddings, concerts, exams, etc.)

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

Read the 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.

Conditions: Stress
Being tested: Light therapy A via the Re-Timer®, Light therapy B via the Re-Timer®, Light therapy C via the Re-Timer®
Keywords: Circadian timing, Mood, Light

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04117347
Study group	Role	What they receive
Light therapy A via the Re-Timer®	Experimental	-15 minutes/day Receives: Device: Light therapy A via the Re-Timer®
Light therapy B via the Re-Timer®	Experimental	-30 minutes/day Receives: Device: Light therapy B via the Re-Timer®
Light therapy C via the Re-Timer®	Experimental	-60 minutes/day Receives: Device: Light therapy C via the Re-Timer®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and treatment week 2 and treatment week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20208 Mar 2023

First posted7 Oct 2019
Study start24 Jan 2020
Primary completion8 Mar 2023
Study completion8 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StressStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04117347
Sponsor's protocol ID: HUM00161267
Other IDs: 1R61MH117157-01A1
Status last verified: Dec 2024
First submitted: 3 Oct 2019
Last updated: 27 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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)

Publications

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.
PubMed 39316998

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
ClinicalTrials.gov ID: NCT04117347
Acronym / sponsor ID: HUM00161267
Conditions: Stress
Keywords: Circadian timing, Mood, Light
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 24 Jan 2020 (actual)
Primary completion: 8 Mar 2023 (actual)
Study completion: 8 Mar 2023 (actual)
First posted: 7 Oct 2019 (actual)
Results: Posted 26 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Light therapy A via the Re-Timer®	Experimental	Device: Light therapy A via the Re-Timer®-15 minutes/day
Light therapy B via the Re-Timer®	Experimental	Device: Light therapy B via the Re-Timer®-30 minutes/day
Light therapy C via the Re-Timer®	Experimental	Device: Light therapy C via the Re-Timer®-60 minutes/day

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Meets criteria for traumatic stress
Normal or corrected to normal vision
Right-handed
Fluency in English
Physically able to travel for study visit attendance

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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.

Results and safety

Results posted to the registry on 26 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Light Therapy A Via the Re-Timer®	15	14
Light Therapy B Via the Re-Timer®	15	13
Light Therapy C Via the Re-Timer®	16	15

Primary outcome: 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. Mean (Standard Deviation). Unit: beta weights

Measure	Light Therapy A Via the Re-Timer® n = 14	Light Therapy B Via the Re-Timer® n = 12	Light Therapy C Via the Re-Timer® n = 13
Baseline (left amygdala)	0.1287 (0.0842)	0.1532 (0.0828)	0.2134 (0.1362)
After 2 weeks of light treatment (left amygdala)	0.1048 (0.0770)	0.1248 (0.0855)	0.0806 (0.1582)
After 4 weeks of light treatment (left amygdala)	0.1155 (0.0927)	0.1191 (0.1047)	0.1375 (0.1399)
Baseline (right amygdala)	0.1437 (0.1480)	0.1969 (0.0882)	0.1899 (0.0830)
After 2 weeks of light treatment (right amygdala)	0.1104 (0.0715)	0.1176 (0.1042)	0.1012 (0.0716)
After 4 weeks of light treatment (right amygdala)	0.1087 (0.1159)	0.1107 (0.1141)	0.1303 (0.0905)

Light Therapy A Via the Re-Timer® vs Light Therapy B Via the Re-Timer®: Coefficient for an indicator: 0.022 (95% CI -0.0861723 to 0.1309519)
Light Therapy A Via the Re-Timer® vs Light Therapy C Via the Re-Timer®: Coefficient for an indicator: 0.068 (95% CI -0.0363877 to 0.1730965)
Light Therapy A Via the Re-Timer® vs Light Therapy B Via the Re-Timer®: Coefficient for an indicator: 0.043 (95% CI -0.0676154 to 0.1545869)

Population analysed: Four participants discontinued the study after randomization: 2 no time for study (Light Therapy B group -30 minute), 1 family emergency (Light Therapy A group - 15 minute), 1 light-triggered headaches (Light Therapy C group - 60 minute). Some participants were not scanned at week 2 due to various reasons (e.g. weather, available funding).

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Light Therapy A Via the Re-Timer®	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Light Therapy B Via the Re-Timer®	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Light Therapy C Via the Re-Timer®	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39316998Burgess 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.
doiLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Burgess principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04117347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.