Personalized Inhibitory Control Training for Compulsive Behavior Change
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 23, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedSeptember 27, 2018
September 1, 2018
1.1 years
August 23, 2018
September 25, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
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
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
Study Arms (2)
P-CIT protocol
EXPERIMENTALOCD patients who receive the P-CIT intervention.
Placebo
PLACEBO COMPARATOROCD patients who don't receive the P-CIT intervention.
Interventions
Eligibility Criteria
You may qualify if:
- OCD patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hebrew University of Jerusalem
Jerusalem, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 23, 2018
First Posted
September 25, 2018
Study Start
July 1, 2018
Primary Completion
July 30, 2019
Study Completion
August 30, 2019
Last Updated
September 27, 2018
Record last verified: 2018-09