Clinical trial NCT03513848: Morning Light Treatment at Home to Reduce PTSD Symptoms
Official title: Morning Light Treatment at Home to Reduce PTSD Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment
timeFrame: Week 2 and Week 6
Secondary outcomes:
measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment
timeFrame: Week 2 and Week 6
Other outcomes:
measure: Change in Sleep Duration Over 4 Weeks of Treatment
timeFrame: Week 2 and Week 6
measure: Change in Sleep Quality Over 4 Weeks of Treatment
timeFrame: Week 2 and Week 6
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Alyson Zalta, PhD
role: PRINCIPAL_INVESTIGATOR
References: