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Personalized Inhibitory Control Training for Compulsive Behavior Change

Personalized Inhibitory Control Training for Compulsive Behavior Change

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03682913
Enrollment
50
Registered
2018-09-25
Start date
2018-07-01
Completion date
2019-08-30
Last updated
2018-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OCD

Brief 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. 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.

Interventions

BEHAVIORALP-CIT protocol

Personalized inhibitory control training for one week.

BEHAVIORALPlacebo

without personalized inhibitory control training for one week.

Sponsors

Hebrew University of Jerusalem
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* OCD patients

Exclusion criteria

* Metal/ electronic device * Under the age of 18 * Pregnant women * Tattoos that cover over 10% of body mass * Chronically ill patients * Psychosis/ Bi-polar * Substance abuse * Sever depression * Active suicide thoughts * Hearing loss

Design outcomes

Primary

MeasureTime frameDescription
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control groupOne week after P-CIT training startsDuring tasks that require inhibition
fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control groupOne week after P-CIT training startsDuring tasks that require inhibition

Secondary

MeasureTime frameDescription
Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo groupOne week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) trainingClinical 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.
Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo groupOne week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) trainingClinical assessment. Structural interview.
Behavioural- OCI-R (Obsessive-Compulsive Inventory) score- change in OCD symptoms in experimental group in comparison to placebo groupOne week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) trainingClinical assessment. Cutoff score of 21 is distinguish individuals with OCD from those without anxiety disorders.

Countries

Israel

Contacts

Primary ContactShahaf Leshem, B.A.
shahaf.leshem@mail.huji.ac.il0545455509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026