Morning Light Treatment at Home to Reduce PTSD Symptoms

NCT ID: NCT03513848

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2018-06-28

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bright Light

Group Type: EXPERIMENTAL

Retimer

Intervention Type: 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.

Dim Light

Group Type: PLACEBO_COMPARATOR

Retimer placebo

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Retimer placebo

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alyson Zalta

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alyson Zalta, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15122102

Identifier Type: -

Identifier Source: org_study_id