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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Personalized Computerized Inhibitory Control Training for OCD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855943
• Other study ID #: ISF 1341/18
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: June 2024

Study information

• Verified date: March 2022
• Source: Hebrew University of Jerusalem
• Contact: Noa Tauber, MA
• Phone: 559714264
• Email: noa.tauber[@]mail.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Personalized Computer Program
Training with a personalized computerized inhibitory training program
• CBT
Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy

Locations

Country	Name	City	State
Israel	Hebrew University of Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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