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Completed

NCT Number: NCT03513848

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Retimer

Device

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.

Retimer placebo

Device

The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.

Primary outcomes

  1. Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment

    Time frame: 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 outcomes

  1. Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment

    Time frame: 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 outcomes

  1. Change in Sleep Duration Over 4 Weeks of Treatment

    Time frame: 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].

  2. Change in Sleep Quality Over 4 Weeks of Treatment

    Time frame: 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].

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 2, 2018
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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