Light Therapy for Obsessive-compulsive Disorder (OCD)

A Circadian Medicine Light-based Intervention for Obsessive-compulsive Disorder (OCD)

The purpose of this study is to examine the effect of a light-based circadian treatment on OCD symptoms in adults with OCD and late bedtimes. This study will have important implications for understanding the role of circadian rhythms in the etiology and treatment of OCD.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Light therapy; Behavioral: Placebo light therapy

Detailed Description

Prior to the start of this study, there are screening procedures to ensure participants meet the criteria for the study. At the first consent screening appointment, participants will learn more about the study and answer questionnaires. All of the results of the screening procedures are confidential and will only be used by the study staff to determine eligibility for the study.

This study is 5 weeks long and involves 4 in-person lab visits at the Sleep and Chronobiology Lab. Participants will be randomly assigned to either an active or placebo light therapy treatment condition. Visit 1 will involve additional screening to determine eligibility, including questionnaires and interviews. If eligible, participants will then track their sleep for 2 weeks at home with a wrist-worn activity monitor and a sleep diary. Visit 2 will take place in the lab from 5:30pm until 1 hour after participants typical bedtime. The investigators will ask participants to provide saliva samples hourly to measure melatonin and complete questionnaires. The investigators will provide treatment instructions at this visit. Investigators will then ask participants to engage in the treatment at home for 3 weeks. Investigators will schedule 1 in-person visit (Visit 3) and 1 phone call to assess adherence to the treatment during these 3 weeks. Visit 4 will take place in the lab after the treatment is finished. Visit 4 will last from 5:30pm until 1.5 hours after participants typical bedtime and will involve hourly saliva samples to measure melatonin, questionnaires, and interviews.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca C Cox, PhD; Phone Number: 303-735-1923; Email: sleep.study@colorado.edu

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309-0554
      • Recruiting
      • Sleep and Chronobiology Laboratory
      • Contact: Rebecca Cox, PhD; Phone Number: 303-735-1923; Email: rebecca.cox@colorado.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary OCD diagnosis (according to the Diagnostic and Statistical Manual of Mental Disorders 5)
• 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.
• Past 6-month substance use disorder
• Lifetime psychosis or bipolar disorder
• Current sleep disorder (DSWPD and insomnia excepted)
• Significant, active suicidal ideation or behaviors in the past 6 months
• Intellectual disability
• Engaged in evidence-based psychotherapy for OCD
• History of light therapy or cognitive behavior therapy for insomnia
• Night shift work or travel outside of Mountain Standard Time in the past month
• Pregnant, trying to become pregnant, or breastfeeding
• Change in psychotropic medication in the past month
• Prescribed or over the counter sleep medication use in the past month
• Beta-block or monoamine oxidase inhibitor use in the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active treatment; Active light therapy	Behavioral: Light therapy; Morning bright light for 60 minutes after awakening
Placebo Comparator: Control treatment; Placebo light therapy	Behavioral: Placebo light therapy; Placebo morning bright light for 60 minutes after awakening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessive-Compulsive Inventory-Revised score	Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale-Brown Obsessive-Compulsive Scale score	Interviewer-assessed OCD symptoms. Minimum score=0, maximum score=40. Higher scores indicate worse outcome	5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circadian phase	Circadian phase assessed by dim light melatonin onset (DLMO)	3 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Investigators: Principal Investigator: Rebecca C Cox, PhD, University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: OCD; sleep; anxiety; circadian
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 270-FP-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Any data generated from the proposed work that is presented in a peer reviewed journal will be de-identified.

Other data that is presented in a peer reviewed journal will be archived indefinitely and made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No