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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

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

noa.tauber@mail.huji.ac.il

First Name & Middle Initial & Last Name & Degree

Noa Tauber, MA

12. IPD Sharing Statement

Plan to Share IPD

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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