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

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ClinicalTrials.gov Identifier: NCT03855943
Recruitment Status : Not yet recruiting
First Posted : February 27, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Noa Tauber, Hebrew University of Jerusalem

Study Description
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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
Obsessive-Compulsive Disorder Behavioral: Personalized Computer Program Behavioral: CBT Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Obsessive-compulsive symptoms measured after 3 weeks of treatment [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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No Contacts or Locations Provided
More Information
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Responsible Party: Noa Tauber, Research Assistant, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier: NCT03855943    
Other Study ID Numbers: ISF 1341/18
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obsessive-Compulsive Disorder
Mental Disorders
Anxiety Disorders