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Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder

This study is currently recruiting participants.
Verified May 2016 by Roseli Shavitt, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02014194
First Posted: December 18, 2013
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Roseli Shavitt, University of Sao Paulo
  Purpose
Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. Already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate knowledge on attentional bias in individuals with OCD through the use of a standardized protocol developed for OCD; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with OCD.

Condition Intervention
Obsessive-compulsive Disorder Behavioral: attentional bias modification treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Roseli Shavitt, University of Sao Paulo:

Primary Outcome Measures:
  • Percentage of reduction of attentional bias [ Time Frame: Patients will be followed an expected average of 7 weeks (baseline, 2 sessions per week - totalizing 5 weeks, 10 sessions and a session after end of treatment). Measures of attentional bias will be assessed in baseline, session 5 and after session 10. ]

Secondary Outcome Measures:
  • Reduction of anxiety symptoms [ Time Frame: Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks) ]

Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: attentional bias modification, placebo
Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms). There are two arms with 15 OCD patients each one.
Behavioral: attentional bias modification treatment
The attentional bias modification treatment is a behavioral computerized program (software e-prime)
Active Comparator: attentional bias modification, active group
Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms).
Behavioral: attentional bias modification treatment
The attentional bias modification treatment is a behavioral computerized program (software e-prime)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: - 30 patients with obsessive-compulsive diagnosis according to DSM-V (with cleaning and or symmetry dimensions)

  • 30 health controls

Exclusion Criteria: - doing any kind of behavioral therapy in the moment

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014194


Locations
Brazil
University of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403010
Contact: Maria Alice Mathis, Phd    55 11 26616972    alicedemathis@gmail.com   
Sponsors and Collaborators
Roseli Shavitt
  More Information

Responsible Party: Roseli Shavitt, MD, Phd, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02014194     History of Changes
Other Study ID Numbers: 13674113.2.0000.0068
First Submitted: November 25, 2013
First Posted: December 18, 2013
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Roseli Shavitt, University of Sao Paulo:
Attentional Bias
Attentional Bias modification treatment

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders