N/A
N=15
Morning Light Treatment at Home to Reduce PTSD Symptoms
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT03513848 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment — 15.11; 2.50 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Retimer (Device); Retimer placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment |
15.11; 2.50 | — |
| SECONDARY Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment |
4.78; 1.17 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03513848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.