Obsessive-Compulsive DisorderOC-GoPhaseINCT03126305
Initial Development and Dissemination of OC-Go
An observational study of Obsessive-Compulsive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The clinical component of Phase I application development examines the clinical utility, feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving treatment through the pediatric OCD… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- OC-Go
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Apr 2018
- 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 9 to 17 years
- All sexes
- Child
Study population: Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents
Who may be able to join
- Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ. of California / Los Angeles / Semel Inst.
Los Angeles, California, 90024-1759
About this study
Official title: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
The clinical component of Phase I application development examines the clinical utility, feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving treatment through the pediatric OCD treatment programs in the UCLA Division of Child and Adolescent Psychiatry
Read the detailed description
This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for Obsessive Compulsive Disorder (OCD), a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- OC-Go
- Keywords
- exposure, response prevention, web-based application
- 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.
OC-GoOther
OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices
| Study group | Role | What they receive |
|---|---|---|
| OC-Go | Approximately 10-20 9-17 year-olds receiving exposure based cognitive behavior therapy for OCD through the UCLA Division of Child and Adolescent Psychiatry OCD treatment programs Receives: Other: OC-Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
10-item self-report measure assessing the usability of the OC-Go application
Measured: 6 weeks
Usability Evaluation for e-Learning Applications (UELA),
54-item self-report measure assessing the usability of the OC-Go application
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 May 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Virtually Better, Inc.
- Responsible party
- Principal investigator, John Piacentini, University of California, Los Angeles
- Investigators
- John Piacentini, Ph.D., Principal investigator, University of California, Los AngelesPeter Tuerk, Ph.D., Principal investigator, Virtually Better, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126305
- Sponsor's protocol ID
- R42MH111277-01A1
- Acronym
- OC-GoPhaseI
- Status last verified
- Nov 2020
- First submitted
- 19 Apr 2017
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
- ClinicalTrials.gov ID
- NCT03126305
- Acronym / sponsor ID
- OC-GoPhaseI / R42MH111277-01A1
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- exposure, response prevention, web-based application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Virtually Better, Inc.
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 24 Apr 2017 (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 clinical component of Phase I application development examines the clinical utility, feasibility, and functionality of the OC-Go application via an 8-month pilot trial consisting of 50 standard CBT sessions augmented with OC-Go in OCD-diagnosed children who are receiving treatment through the pediatric OCD treatment programs in the UCLA Division of Child and Adolescent Psychiatry
Detailed description
This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for Obsessive Compulsive Disorder (OCD), a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OC-Go | – | Other: OC-GoApproximately 10-20 9-17 year-olds receiving exposure based cognitive behavior therapy for OCD through the UCLA Division of Child and Adolescent Psychiatry OCD treatment programs |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents
Key inclusion criteria (1 listed)
- Children receiving exposure based CBT through the UCLA Child OCD, Anxiety and Tic Disorders Clinic or Pediatric OCD Intensive Outpatient Program and their parents
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 |
|---|---|---|
| OC-GoOC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices | Other | OC-Go |
Primary outcome
System Usability Scale (SUS)
Time frame: 6 weeks
10-item self-report measure assessing the usability of the OC-Go application
Usability Evaluation for e-Learning Applications (UELA),
Time frame: 6 weeks
54-item self-report measure assessing the usability of the OC-Go application
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 18 Nov 2020.
- Individual participant dataSharing planned: No
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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.
John Piacentini, Ph.D. principal investigator
University of California, Los Angeles
Peter Tuerk, Ph.D. principal investigator
Virtually Better, Inc.
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 University of California, Los Angeles 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 18 Nov 2020. 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?
System Usability Scale (SUS) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 18 Nov 2020.