PTSD
Conditions
Brief summary
There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and depression.
Interventions
DEVICERetimer placebo
The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
DEVICERetimer
The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (\ 500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Probable PTSD based on the PCL-5 score * Fluent in English * Willingness and ability to comply with the protocol
Exclusion criteria
* Current or recent (past 6 months) alcohol or substance abuse problems * Past or present psychotic or bipolar disorders * Significant suicidal ideation or suicidal behaviors in past 6 months * Unable or unwilling to give written informed consent. * Severe hearing and memory problems. * Cognitive impairment or mental retardation that interferes with subject being able to understand study requirements, consent form, etc. * Special events (e.g. weddings, exams, surgery) planned during 5 weeks of study * Unable to travel for study visits * Pending legal cases/litigation * Has a serious or unstable medical illness (including but not limited to cardiovascular disease, uncontrolled diabetes, advanced liver disease, kidney failure, seizures, cancer which is likely to result in hospitalization in next year). * Reports significant chronic migraine. For migraines, subjects will only be excluded if they report that bright light can trigger migraines. * Vision problems, retinal disease, or history of eye surgery. * Taking photosensitizing medications * Have previously had light treatment. * Uncontrolled narcolepsy, sleep apnea or restless leg syndrome * Likely to have undiagnosed, significant sleep apnea * Likely to have undiagnosed, significant restless leg syndrome * Prescribed hypnotics, over the counter sleep aids and antidepressants permitted providing all medications stable for 30 days before and during the study). All current medications must be non-photosensitizing. * If in psychotherapy must have been for at least 30 days. * People taking melatonin will be asked to abstain for a month before and during the study * Has traveled outside the central time zone * Have worked a night-shift the past month. * Has winter depression * Is pregnant, trying to get pregnant or breastfeeding. * Household has a child \<2 years old or a child that does not sleep through the night * Is unavailable for a 5 week period * Fail urine drug test at screening visit (after prescribed medication accounted for)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment | Week 2 and Week 6 | The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment \[Week 2 through Week 6 of the study\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment | Week 2 and Week 6 | The Patient Health Questionnaire - 9 (PHQ-9) is the gold standard measure of depression symptom severity. Range: 0-27. Higher scores indicate worse outcomes. We will assess change in PHQ-9 scores over 4 weeks of treatment \[Week 2 through Week 6 of the study\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Duration Over 4 Weeks of Treatment | Week 2 and Week 6 | Sleep duration will be captured using actigraphy data collected by the wrist actigraphy monitor worn by subjects throughout the intervention. We will assess change in sleep duration over 4 weeks of treatment \[Week 2 through Week 6 of the study\]. |
| Change in Sleep Quality Over 4 Weeks of Treatment | Week 2 and Week 6 | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) with PTSD addendum. We will assess change in sleep quality over 4 weeks of treatment \[Week 2 through Week 6 of the study\]. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bright Light Retimer: The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (\
500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors. | 9 |
| Dim Light Retimer placebo: The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing. | 6 |
| Total | 15 |
Baseline characteristics
| Characteristic | Bright Light | Dim Light | Total |
|---|---|---|---|
| Age, Continuous | 40.89 years STANDARD_DEVIATION 9.36 | 51.00 years STANDARD_DEVIATION 13.33 | 44.93 years STANDARD_DEVIATION 11.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United States | 9 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 6 |
| other Total, other adverse events | 1 / 9 | 0 / 6 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 |
Outcome results
Primary
Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment
The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment \[Week 2 through Week 6 of the study\].
Time frame: Week 2 and Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light | Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment | 15.11 units on a scale | Standard Deviation 14.38 |
| Dim Light | Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment | 2.50 units on a scale | Standard Deviation 7.5 |
Secondary
Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment
The Patient Health Questionnaire - 9 (PHQ-9) is the gold standard measure of depression symptom severity. Range: 0-27. Higher scores indicate worse outcomes. We will assess change in PHQ-9 scores over 4 weeks of treatment \[Week 2 through Week 6 of the study\].
Time frame: Week 2 and Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light | Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment | 4.78 units on a scale | Standard Deviation 3.73 |
| Dim Light | Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment | 1.17 units on a scale | Standard Deviation 5.95 |
Other Pre-specified
Change in Sleep Duration Over 4 Weeks of Treatment
Sleep duration will be captured using actigraphy data collected by the wrist actigraphy monitor worn by subjects throughout the intervention. We will assess change in sleep duration over 4 weeks of treatment \[Week 2 through Week 6 of the study\].
Time frame: Week 2 and Week 6
Other Pre-specified
Change in Sleep Quality Over 4 Weeks of Treatment
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) with PTSD addendum. We will assess change in sleep quality over 4 weeks of treatment \[Week 2 through Week 6 of the study\].
Time frame: Week 2 and Week 6