Clinical trial NCT01909193: CBT vs. ABM vs. for Social Anxiety
Official title: Cognitive Behavior Therapy vs. Attention Bias Modification Treatment for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
Collaborators: name: Israel Science Foundation
First posted: 2013-07-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy, attention bias modification treatment (allocation ratio - 1.5:1).

Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on Diagnostic and Statistical Manual (DSM) IV criteria.

The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

Detailed description: 120 Adults with Social Anxiety Disorder will be pseudo randomly assigned to either an individual cognitive behavior therapy (CBT), attention bias modification treatment (ABM)).

Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social anxiety disorder derived from structured clinical interviews based on DSM-IV criteria.

The investigators expect to find significant reduction in social anxiety symptoms in all of the groups, with the cognitive behavior therapy group showing greater reduction in symptoms than the other groups. Mechanisms of change in all of the groups will be examined via measures of cognitive biases, affect, and other common and specific factors.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Generalized Social Anxiety Disorder, LSAS\>50
* If on medication, patients must be on a stable dose
* Hebrew language fluency

Exclusion Criteria:

* Primary Axis I or Axis II disorder other than SAD
* suicidal ideation
* Substance dependence within the past three months or current substance abuse
* Mental retardation or another pervasive developmental disability
* Current or past schizophrenia or psychosis, current bipolar disorder, or organic brain syndrome

Primary outcomes:
measure: Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview
timeFrame: Expected time frame of up to 32 weeks per participant. Participants will be assessed before and after the administration of the treatment, every 4 weeks during treatment and at 3 months follow-up
Secondary outcomes:
measure: Social Phobia Inventory (SPIN) - self-report questionnaire
timeFrame: Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 months follow-up
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Hebrew University of Jerusalem
Study officials:
affiliation: Hebrew University of Jerusalem
name: Jonathan D Huppert, PhD
role: PRINCIPAL_INVESTIGATOR
References: