Morning Light Treatment at Home to Reduce PTSD Symptoms

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.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Device: Retimer; Device: Retimer placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Alyson Zalta, PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 15122102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No