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

Not Applicable

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Personalized Computer Program; Behavioral: CBT

• Registration Number: NCT03855943
• Lead Sponsor: Hebrew University of Jerusalem

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.

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Study Start: 2019-04-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01
• Primary Completion: 2024-03
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT + Personalized Computer Program	CBT	Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program
CBT + Personalized Computer Program	Personalized Computer Program	Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program

Primary Outcome Measures

Name	Time	Method
Obsessive-compulsive symptoms measured after 3 weeks of treatment	3 weeks	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

Trial Locations

Locations (1)

Hebrew University of Jerusalem; 🇮🇱 Jerusalem, Israel