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Personalized Inhibitory Control Training for Compulsive Behavior Change

Primary Purpose

OCD

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
P-CIT protocol
Placebo
Sponsored by
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OCD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hebrew University of JerusalemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

P-CIT protocol

Placebo

Arm Description

OCD patients who receive the P-CIT intervention.

OCD patients who don't receive the P-CIT intervention.

Outcomes

Primary Outcome Measures

fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
During tasks that require inhibition
fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
During tasks that require inhibition

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 23, 2018
Last Updated
September 25, 2018
Sponsor
Hebrew University of Jerusalem
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1. Study Identification

Unique Protocol Identification Number
NCT03682913
Brief Title
Personalized Inhibitory Control Training for Compulsive Behavior Change
Official Title
Personalized Inhibitory Control Training for Compulsive Behavior Change
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P-CIT protocol
Arm Type
Experimental
Arm Description
OCD patients who receive the P-CIT intervention.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
OCD patients who don't receive the P-CIT intervention.
Intervention Type
Behavioral
Intervention Name(s)
P-CIT protocol
Intervention Description
Personalized inhibitory control training for one week.
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
without personalized inhibitory control training for one week.
Primary Outcome Measure Information:
Title
fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
Description
During tasks that require inhibition
Time Frame
One week after P-CIT training starts
Title
fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
Description
During tasks that require inhibition
Time Frame
One week after P-CIT training starts
Secondary Outcome Measure Information:
Title
Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo group
Description
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.
Time Frame
One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Title
Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo group
Description
Clinical assessment. Structural interview.
Time Frame
One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Title
Behavioural- OCI-R (Obsessive-Compulsive Inventory) score- change in OCD symptoms in experimental group in comparison to placebo group
Description
Clinical assessment. Cutoff score of 21 is distinguish individuals with OCD from those without anxiety disorders.
Time Frame
One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahaf Leshem, B.A.
Phone
0545455509
Email
shahaf.leshem@mail.huji.ac.il
Facility Information:
Facility Name
The Hebrew University of Jerusalem
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahaf Leshem

12. IPD Sharing Statement

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Personalized Inhibitory Control Training for Compulsive Behavior Change

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