Cognitive Biases Modification Treatment for Social Anxiety (CBMSP)

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.

Study Overview

• Status: Completed
• Conditions: Social Phobia
• Intervention / Treatment: Behavioral: Attention Bias Modification Treatment (ABMT); Behavioral: Control Condition; Behavioral: Interpretation Bias Modification (IBM); Behavioral: Attention and Interpretive biases modification (CBM)

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Tel-Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mini International Neuropsychiatric Interview (MINI).	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)	expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: December 30, 2011
• First Posted (ESTIMATE): January 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: social anxiety; attention training; cognitive bias modification; attention bias modification treatment; interpretive bias modification
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Phobia, Social
• Other Study ID Numbers: CBM_SP_2012