Morning Light Treatment at Home to Reduce PTSD Symptoms

NCT03513848 | Completed Results FDA Device

• 1 other identifier: 15122102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Week 2 and Week 6

Other Outcomes (2)

• Change in Sleep Duration Over 4 Weeks of Treatment

  Week 2 and Week 6

• Change in Sleep Quality Over 4 Weeks of Treatment

  Week 2 and Week 6

Study Arms (2)

Bright Light

EXPERIMENTAL

Device: Retimer

Dim Light

PLACEBO COMPARATOR

Device: Retimer placebo

Interventions

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.

Bright Light

Retimer placebo DEVICE

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

Dim Light

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Probable PTSD based on the PCL-5 score
• Fluent in English
• Willingness and ability to comply with the protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Alyson Zalta
• Organization: University of California, Irvine

azalta@uci.edu

949-824-3409

Study Officials

• Alyson Zalta, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: May 2, 2018
• Study Start: April 1, 2016
• Primary Completion: June 27, 2018
• Study Completion: June 28, 2018
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)