Personalized Inhibitory Control Training for Compulsive Behavior Change

Study Overview
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Brief Summary
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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.

Official Title
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Personalized Inhibitory Control Training for Compulsive Behavior Change

Conditions
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OCD

Intervention / Treatment
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* Behavioral: P-CIT protocol
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |