CBT vs. ABM vs. for Social Anxiety

Social Phobia Clinical Trial

Official title:

Cognitive Behavior Therapy vs. Attention Bias Modification Treatment for Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909193
• Other study ID #: 1624
• Status: Completed
• Phase: N/A
• First received: July 24, 2013
• Last updated: February 22, 2016
• Start date: January 2011
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: Hebrew University of Jerusalem
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Social Phobia

Intervention

Behavioral:
• Attention Bias Modification (ABM)
Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
• Cognitive Behavior Therapy
CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions

Locations

Country	Name	City	State
Israel	The Hebrew University of Jerusalem	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem	Israel Science Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview	LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social situations. The LSAS assesses a wide range of both social interaction and performance/observation situations, which are rated for degree of fear/anxiety and frequency of avoidance.	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	No
Secondary	Social Phobia Inventory (SPIN) - self-report questionnaire	The SPIN is a widely used 17-item self-report questionnaire that assesses fear, avoidance and physiological symptoms of social anxiety.	Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 months follow-up	No