Clinical trial NCT03016052: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Generalized Anxiety Disorder
Keywords: ABMT
social anxiety
generalized anxiety
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
timeFrame: 1 week after treatment completion and 2 months after treatment completion
measure: Change from baseline - The Generalized Anxiety Disorder Severity Scale
timeFrame: 1 week after treatment completion and 2 months after treatment completion
Secondary outcomes:
measure: Change from baseline - the Social Phobia Inventory scores
timeFrame: 1 week after treatment completion and 2 months after treatment completion
measure: Change from baseline - the Penn State Worry Questionnaire
timeFrame: 1 week after treatment completion and 2 months after treatment completion
measure: Change from baseline - the GAD-7
timeFrame: 1 week after treatment completion and 2 months after treatment completion
Other outcomes:
measure: changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis
timeFrame: 1 week after treatment completion and 2 months after treatment completion
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References: