Evaluating the Effects of a Computerized Training Program Coupled With Cognitive Behavioral Therapy (CBT) for OCD.

Personalized Computerized Inhibitory Control Training for OCD

This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Personalized Computer Program; Behavioral: CBT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noa Tauber, MA; Phone Number: 00972 559714264; Email: noa.tauber@mail.huji.ac.il

Study Locations

• Israel
  • Jerusalem, Israel, 9190501
    • Recruiting
    • Hebrew University of Jerusalem
    • Contact: Noa Tauber, MA; Phone Number: 00972 559714264; Email: noa.tauber@mail.huji.ac.il
    • Principal Investigator: Noa Tauber, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CBT + Personalized Computer Program; Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program	Behavioral: Personalized Computer Program; Training with a personalized computerized inhibitory training program; Behavioral: CBT; Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 weeks

Collaborators and Investigators

• Sponsor: Hebrew University of Jerusalem
• Investigators: Principal Investigator: Noa Tauber, MA, Hebrew University of Jerusalem

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2019
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (ACTUAL): February 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: ISF 1341/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No