Light Therapy for Obsessive-compulsive Disorder (OCD)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light therapy
Placebo light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring circadian, sleep, anxiety, OCD
Eligibility Criteria
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
Sites / Locations
- Sleep and Chronobiology LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active treatment
Control treatment
Arm Description
Active light therapy
Placebo light therapy
Outcomes
Primary Outcome Measures
Obsessive-Compulsive Inventory-Revised score
Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome
Secondary Outcome Measures
Yale-Brown Obsessive-Compulsive Scale score
Interviewer-assessed OCD symptoms. Minimum score=0, maximum score=40. Higher scores indicate worse outcome
Full Information
NCT ID
NCT05391503
First Posted
May 20, 2022
Last Updated
October 12, 2023
Sponsor
University of Colorado, Boulder
1. Study Identification
Unique Protocol Identification Number
NCT05391503
Brief Title
Light Therapy for Obsessive-compulsive Disorder (OCD)
Official Title
A Circadian Medicine Light-based Intervention for Obsessive-compulsive Disorder (OCD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
circadian, sleep, anxiety, OCD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
Active light therapy
Arm Title
Control treatment
Arm Type
Placebo Comparator
Arm Description
Placebo light therapy
Intervention Type
Behavioral
Intervention Name(s)
Light therapy
Intervention Description
Morning bright light for 60 minutes after awakening
Intervention Type
Behavioral
Intervention Name(s)
Placebo light therapy
Intervention Description
Placebo morning bright light for 60 minutes after awakening
Primary Outcome Measure Information:
Title
Obsessive-Compulsive Inventory-Revised score
Description
Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale score
Description
Interviewer-assessed OCD symptoms. Minimum score=0, maximum score=40. Higher scores indicate worse outcome
Time Frame
5 weeks
Other Pre-specified Outcome Measures:
Title
Circadian phase
Description
Circadian phase assessed by dim light melatonin onset (DLMO)
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca C Cox, PhD
Phone
303-735-1923
Email
sleep.study@colorado.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca C Cox, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep and Chronobiology Laboratory
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309-0554
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Cox, PhD
Phone
303-735-1923
Email
rebecca.cox@colorado.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Light Therapy for Obsessive-compulsive Disorder (OCD)
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