Obsessive-Compulsive DisorderNCT05391503
Light Therapy for Obsessive-compulsive Disorder (OCD)
A study testing Light therapy in people with Obsessive-Compulsive Disorder, run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Light therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary OCD diagnosis (according to the Diagnostic and Statistical Manual of Mental Disorders 5)
- Bedtime 0100 or later
- Age 18-35
- English speaking
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep and Chronobiology Laboratory
Boulder, Colorado, 80309-0554
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Light therapy, Placebo light therapy
- Keywords
- circadian, sleep, anxiety, OCD
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyBehavioural
Morning bright light for 60 minutes after awakening
Placebo light therapyBehavioural
Placebo morning bright light for 60 minutes after awakening
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Active light therapy Receives: Behavioral: Light therapy |
| Control treatment | Placebo comparator | Placebo light therapy Receives: Behavioral: Placebo light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-Compulsive Inventory-Revised score
Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome
Measured: 3 weeks
Secondary outcomes (1)
Yale-Brown Obsessive-Compulsive Scale score
Interviewer-assessed OCD symptoms. Minimum score=0, maximum score=40. Higher scores indicate worse outcome
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start23 Sep 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Cox, University of Colorado, Boulder
- Investigators
- Rebecca C Cox, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391503
- Sponsor's protocol ID
- 270-FP-22
- Status last verified
- Sep 2024
- First submitted
- 20 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Circadian Medicine Light-based Intervention for Obsessive-compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT05391503
- Acronym / sponsor ID
- 270-FP-22
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- circadian, sleep, anxiety, OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Behavioral: Light therapyActive light therapy |
| Control treatment | Placebo comparator | Behavioral: Placebo light therapyPlacebo light therapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary OCD diagnosis (according to the Diagnostic and Statistical Manual of Mental Disorders 5)
- Bedtime 0100 or later
- Age 18-35
- English speaking
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapyMorning bright light for 60 minutes after awakening | Behavioural | Active treatment |
| Placebo light therapyPlacebo morning bright light for 60 minutes after awakening | Behavioural | Control treatment |
Primary outcome
Obsessive-Compulsive Inventory-Revised score
Time frame: 3 weeks
Self-reported OCD symptoms. Minimum score=0, maximum score=74. Higher scores indicate worse outcome
1 secondary outcome
Yale-Brown Obsessive-Compulsive Scale score
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obsessive-Compulsive Disorder
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Not yet recruiting
tDCS and Symptom Provocation in Treatment-Resistant OCD
Obsessive - Compulsive Disorder
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca C Cox, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy in people with Obsessive-Compulsive Disorder, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsessive-Compulsive Inventory-Revised score (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.