Back to resultsVisual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety
Primary Purpose
Social Anxiety Disorder, Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ABMT
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring ABMT, social anxiety, generalized anxiety
Eligibility Criteria
Inclusion Criteria:
- A signed consent form
- Men and women between the ages of 18 and 65.
- Meeting a current diagnosis of Social Anxiety Disorder (SP) or Generalized Anxiety Disorder according to the DSM-IV
- SP/GAD as the primary diagnosis: In cases of co-morbidity, SP/GAD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.
- Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.
Exclusion Criteria:
- A diagnosis of psychotic or bipolar disorders.
- A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- Drug or alcohol abuse.
- A pharmacological treatment that is not stabilized in the past 3 months.
- Another psychotherapeutic treatment.
- Change in treatment during the study.
- Poor judgment capacity (i.e., children under 18 and special populations).
Sites / Locations
- Tel Aviv University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABMT
Arm Description
The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
Outcomes
Primary Outcome Measures
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern.
Change from baseline - The Generalized Anxiety Disorder Severity Scale
The Generalized Anxiety Disorder Severity Scale (GADSS) is a 6-item interview assessment that evaluates the severity of each of the DSM-IV symptoms of generalized anxiety disorder. It begins with a target worry list to identify situations that are the focus of worry, and continues with six 5-point-scale items to evaluate levels of generalized anxiety severity.
Secondary Outcome Measures
Change from baseline - the Social Phobia Inventory scores
This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68.
Change from baseline - the Penn State Worry Questionnaire
This is a 16-item self-report measure of the worry dimension of generalized anxiety disorder. the questionnaire is composed of statements, and subjects are request to rate how typical each item is of them, ona 5-point scale ranging from "not typical at all" to "very typical". the PSWQ includes 5 reverse questions.
Change from baseline - the GAD-7
This is a 7-item self-report measure of generalized anxiety. Each item is rated on a 4-point scale with a possible score of 0-21. Increasing scores indicating increased functional impairment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03016052
Brief Title
Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety
Official Title
Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in response to deviations from the embedded contingency in attention bias modification treatment (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and clinical improvement.
***As of September 2017, recruitment of SAD participants has concluded.
Detailed Description
all participants, suffering from either social anxiety disorder or generalized anxiety disorder, will receive 6 sessions of ABMT, adapted for an oddball paradigm. two of the sessions will also include simultaneous EEG measurement. the goal of the study is to determine the emergence of vMMN in response to trials deviating the embedded contingency and to examine the correlation between vMMN emergence and clinical improvement of anxiety symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Generalized Anxiety Disorder
Keywords
ABMT, social anxiety, generalized anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABMT
Arm Type
Experimental
Arm Description
The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.
Intervention Type
Behavioral
Intervention Name(s)
ABMT
Other Intervention Name(s)
attention bias modification
Intervention Description
Participants will be trained with a dot-probe task including angry-neutral faces. The task will be adapted for the oddball paradigm, such that in 80% of trials the probe will appear in place of the neutral face, and in 20% of trials in place of the angry face.
Primary Outcome Measure Information:
Title
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
Description
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern.
Time Frame
1 week after treatment completion and 2 months after treatment completion
Title
Change from baseline - The Generalized Anxiety Disorder Severity Scale
Description
The Generalized Anxiety Disorder Severity Scale (GADSS) is a 6-item interview assessment that evaluates the severity of each of the DSM-IV symptoms of generalized anxiety disorder. It begins with a target worry list to identify situations that are the focus of worry, and continues with six 5-point-scale items to evaluate levels of generalized anxiety severity.
Time Frame
1 week after treatment completion and 2 months after treatment completion
Secondary Outcome Measure Information:
Title
Change from baseline - the Social Phobia Inventory scores
Description
This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68.
Time Frame
1 week after treatment completion and 2 months after treatment completion
Title
Change from baseline - the Penn State Worry Questionnaire
Description
This is a 16-item self-report measure of the worry dimension of generalized anxiety disorder. the questionnaire is composed of statements, and subjects are request to rate how typical each item is of them, ona 5-point scale ranging from "not typical at all" to "very typical". the PSWQ includes 5 reverse questions.
Time Frame
1 week after treatment completion and 2 months after treatment completion
Title
Change from baseline - the GAD-7
Description
This is a 7-item self-report measure of generalized anxiety. Each item is rated on a 4-point scale with a possible score of 0-21. Increasing scores indicating increased functional impairment.
Time Frame
1 week after treatment completion and 2 months after treatment completion
Other Pre-specified Outcome Measures:
Title
changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis
Description
structured diagnostic interview for DSM - IV and ICD-10 psychiatric disorders, which takes approximately 20 min to administer and is a valid and time-efficient alternative to the SCID-P and CIDI.
Time Frame
1 week after treatment completion and 2 months after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A signed consent form
Men and women between the ages of 18 and 65.
Meeting a current diagnosis of Social Anxiety Disorder (SP) or Generalized Anxiety Disorder according to the DSM-IV
SP/GAD as the primary diagnosis: In cases of co-morbidity, SP/GAD will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.
Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.
Exclusion Criteria:
A diagnosis of psychotic or bipolar disorders.
A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
Drug or alcohol abuse.
A pharmacological treatment that is not stabilized in the past 3 months.
Another psychotherapeutic treatment.
Change in treatment during the study.
Poor judgment capacity (i.e., children under 18 and special populations).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
69978
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Anxiety
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