- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01909193
CBT vs. ABM vs. for Social Anxiety
Cognitive Behavior Therapy vs. Attention Bias Modification Treatment for Social Anxiety
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel
- The Hebrew University of Jerusalem
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Attention Bias Modification (ABM)
Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
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Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
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Experimental: Cognitive Behavior Therapy
CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
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CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liebovitz Social Anxiety Scale (LSAS) - diagnostic interview
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
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Phobia Inventory (SPIN) - self-report questionnaire
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
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The SPIN is a widely used 17-item self-report questionnaire that assesses fear, avoidance and physiological symptoms of social anxiety.
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Up to 32 weeks per participant. The SPIN will be administered before and after each treatment session and at 3 months follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan D Huppert, PhD, Hebrew University of Jerusalem
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1624
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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