Light Therapy for Obsessive-compulsive Disorder (OCD)

Sponsor

University of Colorado, Boulder (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05391503

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Behavioral: Light therapy Behavioral: Placebo light therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Obsessive-Compulsive Inventory-Revised score [3 weeks]
Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome

Secondary Outcome Measures

Yale-Brown Obsessive-Compulsive Scale score [5 weeks]
Interviewer-assessed OCD symptoms. Minimum score=0, maximum score=40. Higher scores indicate worse outcome

Other Outcome Measures

Circadian phase [3 weeks]
Circadian phase assessed by dim light melatonin onset (DLMO)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Colorado, Boulder

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rebecca Cox, Postdoctoral fellow, University of Colorado, Boulder

ClinicalTrials.gov Identifier:

NCT05391503

Other Study ID Numbers:

270-FP-22

First Posted:

May 26, 2022

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rebecca Cox, Postdoctoral fellow, University of Colorado, Boulder

Additional relevant MeSH terms:

Compulsive Personality Disorder

Obsessive-Compulsive Disorder

Study Results

No Results Posted as of May 31, 2022