Personalized Inhibitory Control Training for Compulsive Behavior Change

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 Overview

• Status: Unknown
• Conditions: OCD
• Intervention / Treatment: Behavioral: P-CIT protocol; Behavioral: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • The Hebrew University of Jerusalem
    • Contact: Shahaf Leshem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P-CIT protocol; OCD patients who receive the P-CIT intervention.	Behavioral: P-CIT protocol; Personalized inhibitory control training for one week.
Placebo Comparator: Placebo; OCD patients who don't receive the P-CIT intervention.	Behavioral: Placebo; without personalized inhibitory control training for one week.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training

Collaborators and Investigators

• Sponsor: Hebrew University of Jerusalem

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): August 30, 2019

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Impulsive Behavior; Compulsive Behavior
• Other Study ID Numbers: 0105-18-HMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No