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

NCT03855943 | Unknown

• 1 other identifier: ISF 1341/18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CBT + Personalized Computer Program

EXPERIMENTAL

Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program

Behavioral: Personalized Computer Program; Behavioral: CBT

Interventions

Personalized Computer Program BEHAVIORAL

Training with a personalized computerized inhibitory training program

CBT + Personalized Computer Program

CBT BEHAVIORAL

Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy

CBT + Personalized Computer Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

Hebrew University of Jerusalem

Jerusalem, 9190501, Israel

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Noa Tauber, MA

  Hebrew University of Jerusalem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noa Tauber, MA

CONTACT

559714264; noa.tauber@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: April 11, 2019
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)