Obsessive-Compulsive DisorderNCT02378896
Personalized Computerized Inhibitory Control Training for OCD
A study testing Personalized Computer Program and Cognitive Behavioral Therapy in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Personalized Computer Program and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Principal diagnosis of OCD (assessed by SCID).
- Clinically significant OCD symptoms (Y-BOCS score of at least 16).
- Have a history of completing a trial of at least 1 EX/RP sessions.
- Have access to a computer or laptop.
Who cannot join
- Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
- Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
- Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
- Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
- Active suicidality warranting immediate clinical care.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiactic Institute
New York, New York, 10032
About this study
This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.
Read the detailed description
This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Personalized Computer Program, Cognitive Behavioral Therapy
- Keywords
- Cognitive Behavioral 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.
Personalized Computer ProgramBehavioural
Training with a personalized computerized inhibitory training program
Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy
| Study group | Role | What they receive |
|---|---|---|
| CBT + Personalized Computer Program | Experimental | Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program Receives: Behavioral: Personalized Computer Program; Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive-compulsive symptoms measured after 3 weeks of treatment
measured by Yale Brown Obsessive Compulsive Scale (YBOCS)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionJan 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen B Simpson, M.D., PhD, Principal investigator, New York State Psychiactic Institute, Anxiety Disorders Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378896
- Sponsor's protocol ID
- #7059
- Status last verified
- Jan 2018
- First submitted
- 27 Feb 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Computerized Inhibitory Control Training for OCD
- ClinicalTrials.gov ID
- NCT02378896
- Acronym / sponsor ID
- #7059
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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 study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.
Detailed description
This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT + Personalized Computer Program | Experimental | Behavioral: Personalized Computer Program, Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Principal diagnosis of OCD (assessed by SCID).
- Clinically significant OCD symptoms (Y-BOCS score of at least 16).
- Have a history of completing a trial of at least 1 EX/RP sessions.
- Have access to a computer or laptop.
Key exclusion criteria (5 listed)
- Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
- Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
- Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
- Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
- Active suicidality warranting immediate clinical care.
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 |
|---|---|---|
| Personalized Computer ProgramTraining with a personalized computerized inhibitory training program | Behavioural | CBT + Personalized Computer Program |
| Cognitive Behavioral TherapyCognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy | Behavioural | CBT + Personalized Computer Program |
Primary outcome
Obsessive-compulsive symptoms measured after 3 weeks of treatment
Time frame: 3 weeks
measured by Yale Brown Obsessive Compulsive Scale (YBOCS)
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 29 Jan 2018.
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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.
Helen B Simpson, M.D., PhD principal investigator
New York State Psychiactic Institute, Anxiety Disorders Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Computer Program and Cognitive Behavioral Therapy in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute 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 5 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 29 Jan 2018. 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?
Obsessive-compulsive symptoms measured after 3 weeks of treatment (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 29 Jan 2018; AzTrials last refreshed its copy on 28 Oct 2026.