Obsessive-Compulsive DisorderOC-GoPhaseIINCT03601312
Randomized Controlled Trial of Standard ERP and OC-Go
A study testing Exposure and Response Prevention and OC-Go in people with Obsessive-Compulsive Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Phase II of this study will examine the efficacy of the OC-Go application via a randomized controlled trial comparing standard exposure and response prevention (ERP) treatment for pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented with OC-Go. 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?
- Exposure and Response Prevention and OC-Go
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 11 Aug 2021
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 9-17 years old
- Primary diagnosis of OCD based on diagnostic interview (ADIS)
- CGI-Severity score > 3
Who cannot join
- Anti-OCD medication/unstable dose (with changes expected during the study)
- Significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low IQ, etc.) precluding the child's ability to complete all study procedures
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: OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
Phase II of this study will examine the efficacy of the OC-Go application via a randomized controlled trial comparing standard exposure and response prevention (ERP) treatment for pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented with OC-Go. A cross-over design will be implemented for these 12 sessions of treatment, in which participants that were randomized to standard ERP will receive OC-Go augmented ERP for the second half of treatment, and vice versa. Efficacy will be investigated in a sample of 32 children with OCD.
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 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
- Exposure and Response Prevention, OC-Go
- 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 PreventionBehavioural
Exposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies.
OC-GoBehavioural
OC-Go is 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. Individuals receiving this intervention will receive exposure and response prevention with OC-Go.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-As-Usual | Active comparator | Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD. Receives: Behavioral: Exposure and Response Prevention |
| OC-Go | Experimental | Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application. Receives: Behavioral: OC-Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homework compliance
Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100
Measured: End of Week 14
Secondary outcomes (2)
Clinical Global Impression - Improvement Scale (acute)
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Measured: End of Week 6
Clinical Global Impression - Improvement Scale (crossover)
The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
Measured: End of Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Nov 2018
- Primary completion18 Jun 2021
- Study completion11 Aug 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will receive 12 weeks of exposure/response/prevention (ERP). Sessions 1 (psychoeducation/hierarchy creation) and 12 (relapse prevention \& generalization training) will be identical across both randomization groups. Treatment sequences for the randomization groups will be as follows: OC-GO-FIRST - Sessions 2-6: ERP+OC-Go, Sessions 7-11: Standard ERP STANDARD ERP-FIRST - Sessions 2-6: Standard ERP, Sessions 7-11: ERP+OC-Go
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 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 Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601312
- Sponsor's protocol ID
- R42MH111277-02
- Acronym
- OC-GoPhaseII
- Status last verified
- Apr 2022
- First submitted
- 5 Jun 2018
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool
- ClinicalTrials.gov ID
- NCT03601312
- Acronym / sponsor ID
- OC-GoPhaseII / R42MH111277-02
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Virtually Better, Inc.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 26 Jul 2018 (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.
Phase II of this study will examine the efficacy of the OC-Go application via a randomized controlled trial comparing standard exposure and response prevention (ERP) treatment for pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented with OC-Go. A cross-over design will be implemented for these 12 sessions of treatment, in which participants that were randomized to standard ERP will receive OC-Go augmented ERP for the second half of treatment, and vice versa. Efficacy will be investigated in a sample of 32 children with OCD.
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive 12 weeks of exposure/response/prevention (ERP). Sessions 1 (psychoeducation/hierarchy creation) and 12 (relapse prevention \& generalization training) will be identical across both randomization groups. Treatment sequences for the randomization groups will be as follows: OC-GO-FIRST - Sessions 2-6: ERP+OC-Go, Sessions 7-11: Standard ERP STANDARD ERP-FIRST - Sessions 2-6: Standard ERP, Sessions 7-11: ERP+OC-Go
| Arm | Type | Receives |
|---|---|---|
| Treatment-As-Usual | Active comparator | Behavioral: Exposure and Response PreventionIndividuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD. |
| OC-Go | Experimental | Behavioral: OC-GoIndividuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 9-17 years old
- Primary diagnosis of OCD based on diagnostic interview (ADIS)
- CGI-Severity score > 3
Key exclusion criteria (2 listed)
- Anti-OCD medication/unstable dose (with changes expected during the study)
- Significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low IQ, etc.) precluding the child's ability to complete all study procedures
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 PreventionExposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies. | Behavioural | Treatment-As-Usual |
| OC-GoOC-Go is 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. Individuals receiving this intervention will receive exposure and response prevention with OC-Go. | Behavioural | OC-Go |
Primary outcome
Homework compliance
Time frame: End of Week 14
Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100
2 secondary outcomes
Clinical Global Impression - Improvement Scale (acute)
Time frame: End of Week 6
Clinical Global Impression - Improvement Scale (crossover)
Time frame: End of Week 14
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 11 Apr 2022.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Response Prevention and OC-Go in people with 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 3 inclusion and 2 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 11 Apr 2022. 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?
Homework compliance (time frame: End of Week 14). 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 11 Apr 2022.