OCDNCT03682913
Personalized Inhibitory Control Training for Compulsive Behavior Change
A study testing P-CIT protocol in people with OCD, run by Hebrew University of Jerusalem at 1 site in Israel.
Trial summary
Obsessive-compulsive disorder (OCD) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform. It has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the OCD cycle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- OCD
- What is being tested?
- P-CIT protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 30 Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OCD patients
Who cannot join
- Metal/ electronic device
- Under the age of 18
- Pregnant women
- Tattoos that cover over 10% of body mass
- Chronically ill patients
- Psychosis/ Bi-polar
Show all 10Show fewer
- Substance abuse
- Sever depression
- Active suicide thoughts
- Hearing loss
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Hebrew University of Jerusalem
Jerusalem
Shahaf Leshem
About this study
Obsessive-compulsive disorder (OCD) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform. It has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the OCD cycle. The main goal of the current proposal, which is based on exciting pilot data, is to test a novel computerized training program to create an association between OCD-related stimuli, which typically trigger the compulsive urge, and the brain system responsible for stopping. The idea is that once this system is triggered, it will be easier for patients to stop the compulsive urge.
- Conditions
- OCD
- Being tested
- P-CIT protocol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-CIT protocolBehavioural
Personalized inhibitory control training for one week.
PlaceboBehavioural
without personalized inhibitory control training for one week.
| Study group | Role | What they receive |
|---|---|---|
| P-CIT protocol | Experimental | OCD patients who receive the P-CIT intervention. Receives: Behavioral: P-CIT protocol |
| Placebo | Placebo comparator | OCD patients who don't receive the P-CIT intervention. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
During tasks that require inhibition
Measured: One week after P-CIT training starts
fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
During tasks that require inhibition
Measured: One week after P-CIT training starts
Secondary outcomes (3)
Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo group
Clinical assessment. Semi-structured interview that assesses the presence and severity of obsessions and compulsions over the past week. The 5-item Obsession Severity and Compulsion Severity subscales are summed to produce a Total Severity score. Symptoms endorsed are rated on a scale from none (0) to extreme (5). The 5-item Obsession Severity and Compulsion Severity subscales are summed to produce a Total Severity score.
Measured: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo group
Clinical assessment. Structural interview.
Measured: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Behavioural- OCI-R (Obsessive-Compulsive Inventory) score- change in OCD symptoms in experimental group in comparison to placebo group
Clinical assessment. Cutoff score of 21 is distinguish individuals with OCD from those without anxiety disorders.
Measured: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jul 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahaf Leshem, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682913
- Sponsor's protocol ID
- 0105-18-HMO
- Status last verified
- Sep 2018
- First submitted
- 23 Aug 2018
- Last updated
- 27 Sep 2018
- 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 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Inhibitory Control Training for Compulsive Behavior Change
- ClinicalTrials.gov ID
- NCT03682913
- Acronym / sponsor ID
- 0105-18-HMO
- Conditions
- OCD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 25 Sep 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.
Obsessive-compulsive disorder (OCD) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform. It has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the OCD cycle. The main goal of the current proposal, which is based on exciting pilot data, is to test a novel computerized training program to create an association between OCD-related stimuli, which typically trigger the compulsive urge, and the brain system responsible for stopping. The idea is that once this system is triggered, it will be easier for patients to stop the compulsive urge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-CIT protocol | Experimental | Behavioral: P-CIT protocolOCD patients who receive the P-CIT intervention. |
| Placebo | Placebo comparator | Behavioral: PlaceboOCD patients who don't receive the P-CIT intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OCD patients
Key exclusion criteria (10 listed)
- Metal/ electronic device
- Under the age of 18
- Pregnant women
- Tattoos that cover over 10% of body mass
- Chronically ill patients
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 |
|---|---|---|
| P-CIT protocolPersonalized inhibitory control training for one week. | Behavioural | P-CIT protocol |
| Placebowithout personalized inhibitory control training for one week. | Behavioural | Placebo |
Primary outcome
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
Time frame: One week after P-CIT training starts
During tasks that require inhibition
fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
Time frame: One week after P-CIT training starts
During tasks that require inhibition
3 secondary outcomes
Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo group
Time frame: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo group
Time frame: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Behavioural- OCI-R (Obsessive-Compulsive Inventory) score- change in OCD symptoms in experimental group in comparison to placebo group
Time frame: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-CIT protocol in people with OCD, 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 1 inclusion and 10 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 27 Sep 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 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. Some participants in this study may receive a placebo. 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 Shahaf Leshem, B.A. (0545455509, shahaf.leshem@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group (time frame: One week after P-CIT training starts). 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 27 Sep 2018.