NCT05391503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

May 20, 2022

Last Update Submit

September 16, 2024

Conditions

Keywords

circadiansleepanxietyOCD

Outcome Measures

Primary Outcomes (1)

  • Obsessive-Compulsive Inventory-Revised score

    Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome

    3 weeks

Secondary Outcomes (1)

  • Yale-Brown Obsessive-Compulsive Scale score

    5 weeks

Other Outcomes (1)

  • Circadian phase

    3 weeks

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Active light therapy

Behavioral: Light therapy

Control treatment

PLACEBO COMPARATOR

Placebo light therapy

Behavioral: Placebo light therapy

Interventions

Light therapyBEHAVIORAL

Morning bright light for 60 minutes after awakening

Active treatment

Placebo morning bright light for 60 minutes after awakening

Control treatment

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary OCD diagnosis (according to the Diagnostic and Statistical Manual of Mental Disorders 5)
  • Bedtime 0100 or later
  • Age 18-35
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80309-0554, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Rebecca C Cox, PhD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral fellow

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 26, 2022

Study Start

September 23, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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.

Locations