- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06720090
Light Therapy for Obsessive-compulsive Disorder (OCD) (KLTO)
Light Therapy for Obsessive-compulsive Disorder: A Circadian Medicine Approach
The goal of this clinical trial is to test whether light therapy is effective for reducing symptoms in young adults with OCD and late bedtimes (1am or later). The main question[s] it aims to answer are:
Does light therapy reduce OCD symptoms? Does light therapy advance the circadian clock? If there is a comparison group: Researchers will compare a higher dose of light therapy to a lower dose to see if dose amount affects symptom reduction.
Participants will asked to:
- Wear light therapy glasses for 1 hour each morning and complete a daily light therapy log for 5 weeks
- Track their sleep every day with a wearable monitor and an electronic sleep diary for 5 weeks
- Complete a 1-time assessment of sensitivity to light exposure
- Complete self-report measures of OCD 4 times/day at baseline (2 weeks), mid-treatment (1 week), and end of treatment (1 week)
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Rebecca Cox, BA
- Phone Number: 314-935-8111
- Email: scraplab@wustl.edu
Study Locations
-
-
Missouri
-
St. Louis, Missouri, United States, 63130
- Recruiting
- Washington University
-
Contact:
- Rebecca Cox, PhD
- Phone Number: 314-935-8111
- Email: cox.r@wustl.edu
-
Principal Investigator:
- Rebecca Cox
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary DSM-5 OCD diagnosis
- Bedtime 0100 or later
- Age 18-35
- English speaking
Exclusion Criteria:
- Subjects must not be currently participating in another research study that would influence their participation in our study.
- Diagnostic status
- Treatment status
- Night shift work or travel more than 1 time zone outside of Central Standard Time (CST) in the past month
- Pregnancy status
- Medication status
- Regular nicotine or marijuana use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Higher dose
Participants will be given wearable light therapy devices that emit a higher light intensity.
|
5 weeks of light therapy administered via wearable light therapy glasses worn for 1 hour each morning after awakening.
|
|
Sham Comparator: Lower dose
Participants will be given wearable light therapy devices that emit a lower light intensity.
|
5 weeks of light therapy administered via wearable light therapy glasses worn for 1 hour each morning after awakening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yale Brown Obsessive-Compulsive Scale (YBOCS)
Time Frame: Administered at baseline, in treatment week 3, and post-treatment (3 administrations over 7 weeks)
|
A retrospective clinical interview of OCD symptom severity.
Score range from 0 to 40 and higher scores indicate more severe OCD symptoms.
|
Administered at baseline, in treatment week 3, and post-treatment (3 administrations over 7 weeks)
|
|
Daily Perseverative Thinking Questionnaire
Time Frame: Administered 4 times/day for 2 weeks at baseline, 4 times/day for 1 week in treatment week 3, and 4 times/day for 1 week in treatment week 5
|
Self-report measure of momentary transdiagnostic repetitive negative thinking.
Score range from 6 to 42 and higher scores indicate more severe repetitive negative thinking.
|
Administered 4 times/day for 2 weeks at baseline, 4 times/day for 1 week in treatment week 3, and 4 times/day for 1 week in treatment week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circadian melatonin phase
Time Frame: At baseline and post-treatment (after 5 weeks of treament)
|
Dim light melatonin onset assessed by taking hourly saliva samples in dim light conditions for 10 hours beginning 7 hours before typical bedtime and ending 2 hours after typical bedtime.
|
At baseline and post-treatment (after 5 weeks of treament)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rebecca Cox, PhD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23MH137376 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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