Morning Light Treatment at Home to Reduce PTSD Symptoms

Study Overview
=================
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.

Official Title
-----------------
Morning Light Treatment at Home to Reduce PTSD Symptoms

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Device: Retimer
* Device: Retimer placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright Light<br> | Device: Retimer<br>* 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.<br>|
| Placebo Comparator: Dim Light<br> | Device: Retimer placebo<br>* The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | Week 2 and Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | Week 2 and Week 6 |