Back to resultsAttentional Bias Modification Treatment in OCD
Primary Purpose
Obsessive-compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
attentional bias modification treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring Attentional Bias, Attentional Bias modification treatment
Eligibility 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
Sites / Locations
- University of Sao Paulo Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
attentional bias modification, placebo
attentional bias modification, active group
Arm Description
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.
Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms).
Outcomes
Primary Outcome Measures
Percentage of reduction of attentional bias
Secondary Outcome Measures
Reduction of anxiety symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02014194
Brief Title
Attentional Bias Modification Treatment in OCD
Official Title
Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roseli Shavitt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
Attentional Bias, Attentional Bias modification treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
attentional bias modification, placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
attentional bias modification, active group
Arm Type
Active Comparator
Arm Description
Measure of attentional bias modification treatment after 10 sessions of attentional bias modification (two arms).
Intervention Type
Behavioral
Intervention Name(s)
attentional bias modification treatment
Intervention Description
The attentional bias modification treatment is a behavioral computerized program (software e-prime)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Reduction of anxiety symptoms
Time Frame
Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Sao Paulo Medical School
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil
12. IPD Sharing Statement
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Attentional Bias Modification Treatment in OCD
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