Obsessive-Compulsive DisorderNCT03855943
Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.
A study testing Personalized Computer Program and CBT in people with Obsessive-Compulsive Disorder, run by Hebrew University of Jerusalem at 1 site in Israel.
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 CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Apr 2019to Jun 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 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 14).
- Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
- 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.
- Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
- 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.
Israel1 site, 1 recruiting
- Recruiting
Hebrew University of Jerusalem
Jerusalem, 9190501
Noa Tauber, MA, 559714264 ext. 00972, noa.tauber@mail.huji.ac.il
Noa Tauber, MA
About this study
Official title: Personalized Computerized Inhibitory Control Training for OCD
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, CBT
- 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
CBTBehavioural
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: CBT |
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), considered the gold standard assessment tool.
Y-BOCS comprises a Symptom Checklist and Severity Scale to consecutively rate obsessions and compulsions. The Checklist includes 54 common obsessions and compulsive behaviors, which are grouped according to thematic content. Symptoms that are endorsed over the past week are then globally rated by the clinician using a five-point scale ranging from 0 (none) to 4 (extreme) across five dimensions: (1) time/frequency, (2) interference, (3) distress, (4) resistance, and (5) degree of control. Obsessive and compulsive symptom severity are rated separately (scores range from 0 to 25) with these scores summed to create a total OCD severity score (range, 0-50).
Symptom severity scores: mild symptoms (0-13), moderate symptoms (14-25), moderate-severe symptoms (26-34), and severe symptoms (35-40).26
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 posted27 Feb 2019
- Study start11 Apr 2019
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noa Tauber, Hebrew University of Jerusalem
- Investigators
- Noa Tauber, MA, Principal investigator, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855943
- Sponsor's protocol ID
- ISF 1341/18
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2019
- Last updated
- 1 Apr 2022
- Results posted
- 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 1 Apr 2022. 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
- NCT03855943
- Acronym / sponsor ID
- ISF 1341/18
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Feb 2019 (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 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: CBTCognitive 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 14).
- Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
- Have access to a computer or laptop.
Key exclusion criteria (6 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.
- Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
- Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
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 |
| CBTCognitive 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), considered the gold standard assessment tool. Y-BOCS comprises a Symptom Checklist and Severity Scale to consecutively rate obsessions and compulsions. The Checklist includes 54 common obsessions and compulsive behaviors, which are grouped according to thematic content. Symptoms that are endorsed over the past week are then globally rated by the clinician using a five-point scale ranging from 0 (none) to 4 (extreme) across five dimensions: (1) time/frequency, (2) interference, (3) distress, (4) resistance, and (5) degree of control. Obsessive and compulsive symptom severity are rated separately (scores range from 0 to 25) with these scores summed to create a total OCD severity score (range, 0-50). Symptom severity scores: mild symptoms (0-13), moderate symptoms (14-25), moderate-severe symptoms (26-34), and severe symptoms (35-40).26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Noa Tauber, MA principal investigator
Hebrew University of Jerusalem
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 CBT in people with Obsessive-Compulsive Disorder, run by Hebrew University of Jerusalem at 1 site in Israel.
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 6 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: status not confirmed, as of the sponsor's last update on 1 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noa Tauber, MA (559714264 ext. 00972, noa.tauber@mail.huji.ac.il), or a site near the patient. 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 1 Apr 2022.