Stress
Conditions
Keywords
Circadian timing, Mood, Light
Brief summary
The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.
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.
Interventions
DEVICELight therapy A via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
DEVICELight therapy B via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
DEVICELight therapy C via the Re-Timer®
Subjects will conduct light treatment in the mornings at home.
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | 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. |
Countries
United States
Participant flow
Pre-assignment details
Four participants withdrew after study enrollment but before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| 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. | 16 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Family emergency | 1 | 0 | 0 |
| Overall Study | No time for study | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Light Therapy A Via the Re-Timer® | Light Therapy B Via the Re-Timer® | Light Therapy C Via the Re-Timer® | Total |
|---|---|---|---|---|
| Age, Continuous | 34.10 years STANDARD_DEVIATION 12.03 | 36.45 years STANDARD_DEVIATION 10.58 | 30.69 years STANDARD_DEVIATION 8.85 | 33.68 years STANDARD_DEVIATION 10.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 15 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| fMRI BOLD signal change in amygdala fMRI BOLD signal change in left amygdala | 0.1311 beta weight STANDARD_DEVIATION 0.0816 | 0.1410 beta weight STANDARD_DEVIATION 0.0822 | 0.2065 beta weight STANDARD_DEVIATION 0.1333 | 0.1589 beta weight STANDARD_DEVIATION 0.1047 |
| fMRI BOLD signal change in amygdala fMRI BOLD signal change in right amygdala | 0.1611 beta weight STANDARD_DEVIATION 0.1577 | 0.1800 beta weight STANDARD_DEVIATION 0.0936 | 0.1858 beta weight STANDARD_DEVIATION 0.0812 | 0.1753 beta weight STANDARD_DEVIATION 0.1147 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 12 Participants | 13 Participants | 37 Participants |
| Region of Enrollment United States | 15 Participants | 15 Participants | 16 Participants | 46 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 10 Participants | 34 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 1 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 16 |
Outcome results
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.
Time frame: Baseline and treatment week 2 and treatment week 4
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy A Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | Baseline (left amygdala) | 0.1287 beta weights | Standard Deviation 0.0842 |
| Light Therapy A Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 2 weeks of light treatment (left amygdala) | 0.1048 beta weights | Standard Deviation 0.077 |
| Light Therapy A Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 4 weeks of light treatment (left amygdala) | 0.1155 beta weights | Standard Deviation 0.0927 |
| Light Therapy A Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | Baseline (right amygdala) | 0.1437 beta weights | Standard Deviation 0.148 |
| Light Therapy A Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 2 weeks of light treatment (right amygdala) | 0.1104 beta weights | Standard Deviation 0.0715 |
| Light Therapy A Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 4 weeks of light treatment (right amygdala) | 0.1087 beta weights | Standard Deviation 0.1159 |
| Light Therapy B Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 4 weeks of light treatment (right amygdala) | 0.1107 beta weights | Standard Deviation 0.1141 |
| Light Therapy B Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | Baseline (left amygdala) | 0.1532 beta weights | Standard Deviation 0.0828 |
| Light Therapy B Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | Baseline (right amygdala) | 0.1969 beta weights | Standard Deviation 0.0882 |
| Light Therapy B Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 2 weeks of light treatment (right amygdala) | 0.1176 beta weights | Standard Deviation 0.1042 |
| Light Therapy B Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 2 weeks of light treatment (left amygdala) | 0.1248 beta weights | Standard Deviation 0.0855 |
| Light Therapy B Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 4 weeks of light treatment (left amygdala) | 0.1191 beta weights | Standard Deviation 0.1047 |
| Light Therapy C Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 2 weeks of light treatment (left amygdala) | 0.0806 beta weights | Standard Deviation 0.1582 |
| Light Therapy C Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 4 weeks of light treatment (left amygdala) | 0.1375 beta weights | Standard Deviation 0.1399 |
| Light Therapy C Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 4 weeks of light treatment (right amygdala) | 0.1303 beta weights | Standard Deviation 0.0905 |
| Light Therapy C Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | Baseline (right amygdala) | 0.1899 beta weights | Standard Deviation 0.083 |
| Light Therapy C Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | Baseline (left amygdala) | 0.2134 beta weights | Standard Deviation 0.1362 |
| Light Therapy C Via the Re-Timer® | Change in Amygdala Reactivity as Measured by Blood-oxygen-level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal | After 2 weeks of light treatment (right amygdala) | 0.1012 beta weights | Standard Deviation 0.0716 |
Comparison: Analysis for left amygdala.95% CI: [-0.0861723, 0.1309519]
Comparison: Analysis for left amygdala.95% CI: [-0.0363877, 0.1730965]
Comparison: Analysis for right amygdala.95% CI: [-0.0676154, 0.1545869]
Comparison: Analysis for right amygdala.95% CI: [-0.0888691, 0.1255146]