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

Sponsor
Hebrew University of Jerusalem (Other)
Overall Status
Recruiting
CT.gov ID
NCT03855943
Collaborator
(none)
100
1
1
61.7
1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personalized Computer Program
  • Behavioral: CBT
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Personalized Computerized Inhibitory Control Training for OCD
Actual Study Start Date :
Apr 11, 2019
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hebrew University of Jerusalem Jerusalem Israel 9190501

Sponsors and Collaborators

  • Hebrew University of Jerusalem

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noa Tauber, Research Assistant, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier:
NCT03855943
Other Study ID Numbers:
  • ISF 1341/18
First Posted:
Feb 27, 2019
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022