Personalized Inhibitory Control Training for Compulsive Behavior Change

OCD Clinical Trial

Official title:

Personalized Inhibitory Control Training for Compulsive Behavior Change

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03682913
• Other study ID #: 0105-18-HMO
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2018
• Source: Hebrew University of Jerusalem
• Contact: Shahaf Leshem, B.A.
• Phone: 0545455509
• Email: shahaf.leshem[@]mail.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Compulsive Behavior
• OCD

Intervention

Behavioral:
• P-CIT protocol
Personalized inhibitory control training for one week.
• Placebo
without personalized inhibitory control training for one week.

Locations

Country	Name	City	State
Israel	The Hebrew University of Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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