Cognitive Biases Modification Treatment for Social Anxiety (CBMSP)

This study is currently recruiting participants.
Verified December 2011 by Tel Aviv University
Sponsor:
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01503151
First received: December 29, 2011
Last updated: January 12, 2012
Last verified: December 2011
  Purpose

Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.

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

The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.


Condition Intervention Phase
Social Phobia
Behavioral: Attention Bias Modification Treatment (ABMT)
Behavioral: Interpretation Bias Modification (IBM)
Behavioral: Control Condition
Behavioral: Attention and Interpretive biases modification (CBM)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cognitive Biases Modification Treatment for Social Anxiety

Resource links provided by NLM:


Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Social Anxiety Scale (LSAS) - diagnostic interview [ Time Frame: Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols ] [ Designated as safety issue: No ]
    LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social. 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:
  • The Mini International Neuropsychiatric Interview (MINI). [ Time Frame: expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols ] [ Designated as safety issue: No ]
    The Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview (DSI) developed to explore 17 disorders according to Diagnostic and Statistical Manual diagnostic criteria (DSM)


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns.
Behavioral: Control Condition
Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
Experimental: Attention Bias Modification (ABM)
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Behavioral: Attention Bias Modification Treatment (ABMT)
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
Experimental: Interpretation Bias Modification (IBM)
Interpretation training intended to facilitating a more benign interpretation bias
Behavioral: Interpretation Bias Modification (IBM)
Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
Experimental: Attention and interpretation biases modification
Attention and interpretation training intended to direct cognitive biases away from threat stimulus.
Behavioral: Attention and Interpretive biases modification (CBM)
Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503151

Contacts
Contact: Yair Bar-Haim, PhD 972-3-6405465 yair1@post.tau.ac.il
Contact: Reut Naim, M.A. 972-54-6570555 reutnaim@gmail.com

Locations
Israel
Tel-Aviv University Recruiting
Tel-Aviv, Israel
Contact: Yair Bar-Haim, Professor    972-3-6405465    yair1@post.tau.ac.il   
Contact: Reut Naim, M.A.    972-54-6570555    reutnaim@gmail.com   
Principal Investigator: Yair Bar- Haim, Professor         
Sponsors and Collaborators
Tel Aviv University
  More Information

No publications provided

Responsible Party: Yair Bar-Haim, Study Principal Investigator, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01503151     History of Changes
Other Study ID Numbers: CBM_SP_2012
Study First Received: December 29, 2011
Last Updated: January 12, 2012
Health Authority: Israel: Tel Aviv University Ethics Commission

Keywords provided by Tel Aviv University:
attention bias modification treatment
interpretive bias modification
cognitive bias modification
attention training
social anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014