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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61MH117157-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light therapy A via the Re-Timer® | Experimental | -15 minutes/day |
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| Light therapy B via the Re-Timer® | Experimental | -30 minutes/day |
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| Light therapy C via the Re-Timer® | Experimental | -60 minutes/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light therapy A via the Re-Timer® | Device | Subjects will conduct light treatment in the mornings at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Burgess | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39316998 | Result | 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. |
| Label | URL |
|---|---|
| doi | View source |
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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)
After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
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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Four participants withdrew after study enrollment but before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Therapy A Via the Re-Timer® | -15 minutes/day Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| FG001 | Light Therapy B Via the Re-Timer® | -30 minutes/day Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| FG002 | Light Therapy C Via the Re-Timer® | -60 minutes/day Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Therapy A Via the Re-Timer® | -15 minutes/day Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| BG001 | Light Therapy B Via the Re-Timer® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | beta weights | Baseline and treatment week 2 and treatment week 4 |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Light Therapy A Via the Re-Timer® | -15 minutes/day Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light-triggered headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helen Burgess | University of Michigan | 734-615-8303 | bhelen@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2022 | Feb 23, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2022 | Apr 11, 2023 | ICF_000.pdf |
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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.
| Light therapy B via the Re-Timer® | Device | Subjects will conduct light treatment in the mornings at home. |
|
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| Light therapy C via the Re-Timer® | Device | Subjects will conduct light treatment in the mornings at home. |
|
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| Family emergency |
|
-30 minutes/day
Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home.
| BG002 | Light Therapy C Via the Re-Timer® | -60 minutes/day Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| fMRI BOLD signal change in amygdala | 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. | Data from some participants were lost due to poor task performance in the fMRI. This included 0 participants in the Light Therapy A group (15 minute), 1 participant in the Light Therapy B group (30 minute) and 2 participants in the Light Therapy C group (60 minute). | Mean | Standard Deviation | beta weight |
|
-15 minutes/day Light therapy A via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| OG001 | Light Therapy B Via the Re-Timer® | -30 minutes/day Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
| OG002 | Light Therapy C Via the Re-Timer® | -60 minutes/day Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Light Therapy B Via the Re-Timer® | -30 minutes/day Light therapy B via the Re-Timer®: Subjects conducted light treatment in the mornings at home. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Light Therapy C Via the Re-Timer® | -60 minutes/day Light therapy C via the Re-Timer®: Subjects conducted light treatment in the mornings at home. | 0 | 16 | 0 | 16 | 1 | 16 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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