Cognitive Biases Modification Treatment for Social Anxiety (CBMSP)

This study is currently recruiting participants. (see Contacts and Locations)
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

December 29, 2011
January 12, 2012
January 2012
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01503151 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Cognitive Biases Modification Treatment for Social Anxiety
Cognitive Biases Modification Treatment for Social Anxiety

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Social Phobia
  • Behavioral: Attention Bias Modification Treatment (ABMT)
    Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
  • Behavioral: Interpretation Bias Modification (IBM)
    Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
  • Behavioral: Control Condition
    Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
  • 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.
  • 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.
    Intervention: Behavioral: Control Condition
  • Experimental: Attention Bias Modification (ABM)
    Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
    Intervention: Behavioral: Attention Bias Modification Treatment (ABMT)
  • Experimental: Interpretation Bias Modification (IBM)
    Interpretation training intended to facilitating a more benign interpretation bias
    Intervention: Behavioral: Interpretation Bias Modification (IBM)
  • Experimental: Attention and interpretation biases modification
    Attention and interpretation training intended to direct cognitive biases away from threat stimulus.
    Intervention: Behavioral: Attention and Interpretive biases modification (CBM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2015
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

Both
18 Years to 65 Years
No
Contact: Yair Bar-Haim, PhD 972-3-6405465 yair1@post.tau.ac.il
Contact: Reut Naim, M.A. 972-54-6570555 reutnaim@gmail.com
Israel
 
NCT01503151
CBM_SP_2012
No
Yair Bar-Haim, Tel Aviv University
Tel Aviv University
Not Provided
Not Provided
Tel Aviv University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP