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Clinical Trials/NCT03855943
NCT03855943UnknownNot Applicable

Personalized Computerized Inhibitory Control Training for OCD

Hebrew University of Jerusalem2 sites in 1 country100 target enrollmentStarted: April 11, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
2
Primary Endpoint
Obsessive-compulsive symptoms measured after 3 weeks of treatment

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Noa Tauber

Research Assistant

Hebrew University of Jerusalem

Study Sites (2)

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