Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.
Primary Purpose
Obsessive-Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Personalized Computer Program
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Principal diagnosis of OCD (assessed by SCID).
- Clinically significant OCD symptoms (Y-BOCS score of at least 14).
- Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
- Have access to a computer or laptop.
Exclusion Criteria:
- Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
- Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
- Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
- Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
- Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
- Active suicidality warranting immediate clinical care.
Sites / Locations
- Hebrew University of JerusalemRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT + Personalized Computer Program
Arm Description
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program
Outcomes
Primary Outcome Measures
Obsessive-compulsive symptoms measured after 3 weeks of treatment
Measured by Yale-Brown Obsessive Compulsive Scale (YBOCS), considered the gold standard assessment tool.
Y-BOCS comprises a Symptom Checklist and Severity Scale to consecutively rate obsessions and compulsions. The Checklist includes 54 common obsessions and compulsive behaviors, which are grouped according to thematic content. Symptoms that are endorsed over the past week are then globally rated by the clinician using a five-point scale ranging from 0 (none) to 4 (extreme) across five dimensions: (1) time/frequency, (2) interference, (3) distress, (4) resistance, and (5) degree of control. Obsessive and compulsive symptom severity are rated separately (scores range from 0 to 25) with these scores summed to create a total OCD severity score (range, 0-50).
Symptom severity scores: mild symptoms (0-13), moderate symptoms (14-25), moderate-severe symptoms (26-34), and severe symptoms (35-40).26
Secondary Outcome Measures
Full Information
NCT ID
NCT03855943
First Posted
February 25, 2019
Last Updated
March 21, 2022
Sponsor
Hebrew University of Jerusalem
1. Study Identification
Unique Protocol Identification Number
NCT03855943
Brief Title
Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.
Official Title
Personalized Computerized Inhibitory Control Training for OCD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (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
5. Study Description
Brief Summary
This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.
Detailed Description
This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT + Personalized Computer Program
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program
Intervention Type
Behavioral
Intervention Name(s)
Personalized Computer Program
Intervention Description
Training with a personalized computerized inhibitory training program
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy
Primary Outcome Measure Information:
Title
Obsessive-compulsive symptoms measured after 3 weeks of treatment
Description
Measured by Yale-Brown Obsessive Compulsive Scale (YBOCS), considered the gold standard assessment tool.
Y-BOCS comprises a Symptom Checklist and Severity Scale to consecutively rate obsessions and compulsions. The Checklist includes 54 common obsessions and compulsive behaviors, which are grouped according to thematic content. Symptoms that are endorsed over the past week are then globally rated by the clinician using a five-point scale ranging from 0 (none) to 4 (extreme) across five dimensions: (1) time/frequency, (2) interference, (3) distress, (4) resistance, and (5) degree of control. Obsessive and compulsive symptom severity are rated separately (scores range from 0 to 25) with these scores summed to create a total OCD severity score (range, 0-50).
Symptom severity scores: mild symptoms (0-13), moderate symptoms (14-25), moderate-severe symptoms (26-34), and severe symptoms (35-40).26
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Principal diagnosis of OCD (assessed by SCID).
Clinically significant OCD symptoms (Y-BOCS score of at least 14).
Allowed to be on medications if they have been on a stable dose for at least 12 weeks prior to the study and will remain on a stable dose during this study.
Have access to a computer or laptop.
Exclusion Criteria:
Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
Patients with a history of more than 8 hours of therapist-assisted ERP for OCD in the past 6 months,
Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
Active suicidality warranting immediate clinical care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noa Tauber, MA
Phone
559714264
Ext
00972
Email
noa.tauber@mail.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noa Tauber, MA
Organizational Affiliation
Hebrew University of Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebrew University of Jerusalem
City
Jerusalem
ZIP/Postal Code
9190501
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noa Tauber, MA
Phone
559714264
Ext
00972
Email
noa.tauber@mail.huji.ac.il
First Name & Middle Initial & Last Name & Degree
Noa Tauber, MA
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.
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