Obsessive-Compulsive DisorderNCT04701372
Clinical Outcomes From NOCD Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention
An observational study of Obsessive-Compulsive Disorder, run by NOCD at 1 site in United States.
Trial summary
This is a naturalistic, observational study of individuals with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy, augmented with between-session support with text messaging and an online community forum. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Exposure and response prevention therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,069 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 8 Nov 2020
- Phase
- Observational
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a naturalistic sample of children, adolescents, and adults with obsessive-compulsive disorder (OCD) who sought treatment for OCD from NOCD, LLC, a digital behavioral health company.
Who may be able to join
- obsessive-compulsive disorder
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes From NOCD Digital Behavioral Health Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention
This is a naturalistic, observational study of individuals with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy, augmented with between-session support with text messaging and an online community forum.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Exposure and response prevention therapy
- Keywords
- exposure and response prevention, digital behavioral health, remote treatment, video therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and response prevention therapyBehavioural
Exposures and response prevention therapy (a type of cognitive-behavioral therapy for obsessive-compulsive disorder), delivered in real-time by licensed therapists remotely via video. The treatment was augmented by between-session text messaging and online community support.
| Study group | Role | What they receive |
|---|---|---|
| Obsessive-Compulsive Disorder | adults, adolescents, and children with obsessive-compulsive disorder Receives: Behavioral: Exposure and response prevention therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional Obsessive-Compulsive Scale
self-rated psychometric instrument to measure symptom severity of multiple OCD subtypes
Measured: change from pre-treatment to post-treatment (after 11 weeks)
Secondary outcomes (3)
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) OCD severity scale
clinician-rated psychometric instrument to measure overall OCD symptom severity
Measured: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Depression Anxiety and Stress Scale (DASS-21)
self-rated psychometric instrument to measure depression, anxiety, and stress
Measured: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (QLES-Q)
self-rated psychometric instrument to measure quality of life
Measured: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jan 2020
- Primary completion8 Nov 2020
- Study completion8 Nov 2020
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- NOCD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701372
- Sponsor's protocol ID
- NOCD001
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes From NOCD Digital Behavioral Health Treatment of Obsessive-Compulsive Disorder Using Exposure and Response Prevention
- ClinicalTrials.gov ID
- NCT04701372
- Acronym / sponsor ID
- NOCD001
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- exposure and response prevention, digital behavioral health, remote treatment, video therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,069 participants (actual)
- Lead sponsor
- NOCDIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 8 Nov 2020 (actual)
- Study completion
- 8 Nov 2020 (actual)
- First posted
- 8 Jan 2021 (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.
This is a naturalistic, observational study of individuals with obsessive-compulsive disorder who were treated with exposure and response prevention via video teletherapy, augmented with between-session support with text messaging and an online community forum.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obsessive-Compulsive Disorder | – | Behavioral: Exposure and response prevention therapyadults, adolescents, and children with obsessive-compulsive disorder |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a naturalistic sample of children, adolescents, and adults with obsessive-compulsive disorder (OCD) who sought treatment for OCD from NOCD, LLC, a digital behavioral health company.
Key inclusion criteria (1 listed)
- obsessive-compulsive disorder
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Exposure and response prevention therapyExposures and response prevention therapy (a type of cognitive-behavioral therapy for obsessive-compulsive disorder), delivered in real-time by licensed therapists remotely via video. The treatment was augmented by between-session text messaging and online community support. | Behavioural | Obsessive-Compulsive Disorder |
Primary outcome
Dimensional Obsessive-Compulsive Scale
Time frame: change from pre-treatment to post-treatment (after 11 weeks)
self-rated psychometric instrument to measure symptom severity of multiple OCD subtypes
3 secondary outcomes
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) OCD severity scale
Time frame: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Depression Anxiety and Stress Scale (DASS-21)
Time frame: pre-treatment, after 4 weeks, and post-treatment (after 11 weeks)
Quality of Life Enjoyment and Satisfaction Questionnaire -- Short Form (QLES-Q)
Time frame: pre-treatment, after 4 weeks, and post-treatment (after 11 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 8 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by NOCD 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 1 inclusion and 1 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 8 Jan 2021. 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. 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?
Dimensional Obsessive-Compulsive Scale (time frame: change from pre-treatment to post-treatment (after 11 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 8 Jan 2021.