Personalized Inhibitory Control Training for Compulsive Behavior Change

Not Applicable

• Conditions: OCD
• Interventions: Behavioral: P-CIT protocol; Behavioral: Placebo

• Registration Number: NCT03682913
• Lead Sponsor: Hebrew University of Jerusalem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-08-23
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-25
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27
• Primary Completion: 2019-07-30
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P-CIT protocol	P-CIT protocol	OCD patients who receive the P-CIT intervention.
Placebo	Placebo	OCD patients who don't receive the P-CIT intervention.

Primary Outcome Measures

Name	Time	Method
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group	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	One week after P-CIT training starts	During tasks that require inhibition

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Hebrew University of Jerusalem; 🇮🇱 Jerusalem, Israel