NCT01909193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

July 24, 2013

Last Update Submit

February 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Social Phobia Inventory (SPIN) - self-report questionnaire

    Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 months follow-up

Study Arms (2)

Attention Bias Modification (ABM)

EXPERIMENTAL

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

Behavioral: Attention Bias Modification (ABM)

Cognitive Behavior Therapy

EXPERIMENTAL

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

Behavioral: Cognitive Behavior Therapy

Interventions

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

Attention Bias Modification (ABM)

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

Cognitive Behavior Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hebrew University of Jerusalem

Jerusalem, Israel

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jonathan D Huppert, PhD

    Hebrew University of Jerusalem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Psychology

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations