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CBT vs. ABM vs. for Social Anxiety

Primary Purpose

Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention Bias Modification (ABM)
Cognitive Behavior Therapy
Sponsored by
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hebrew University of Jerusalem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Attention Bias Modification (ABM)

Cognitive Behavior Therapy

Arm Description

Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.

CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 24, 2013
Last Updated
February 22, 2016
Sponsor
Hebrew University of Jerusalem
Collaborators
Israel Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01909193
Brief Title
CBT vs. ABM vs. for Social Anxiety
Official Title
Cognitive Behavior Therapy vs. Attention Bias Modification Treatment for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem
Collaborators
Israel Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Bias Modification (ABM)
Arm Type
Experimental
Arm Description
Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Arm Title
Cognitive Behavior Therapy
Arm Type
Experimental
Arm Description
CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification (ABM)
Intervention Description
Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
Primary Outcome Measure Information:
Title
Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Social Phobia Inventory (SPIN) - self-report questionnaire
Description
The SPIN is a widely used 17-item self-report questionnaire that assesses fear, avoidance and physiological symptoms of social anxiety.
Time Frame
Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Huppert, PhD
Organizational Affiliation
Hebrew University of Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hebrew University of Jerusalem
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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CBT vs. ABM vs. for Social Anxiety

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