- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014194
Attentional Bias Modification Treatment in OCD
January 23, 2018 updated by: Roseli Shavitt
Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 05403010
- University of Sao Paulo Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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The attentional bias modification treatment is a behavioral computerized program (software e-prime)
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Active Comparator: attentional bias modification, active group
Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms).
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The attentional bias modification treatment is a behavioral computerized program (software e-prime)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of anxiety symptoms
Time Frame: Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)
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Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
November 25, 2013
First Submitted That Met QC Criteria
December 17, 2013
First Posted (Estimate)
December 18, 2013
Study Record Updates
Last Update Posted (Actual)
January 25, 2018
Last Update Submitted That Met QC Criteria
January 23, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13674113.2.0000.0068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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