Cognitive Biases Modification Treatment for Social Anxiety

Phase 2

Completed

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

• Registration Number: NCT01503151
• Lead Sponsor: Tel Aviv University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-30
• Study Start: 2012-01
• Study First Posted: 2012-01-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

People suffering from social anxiety

Exclusion Criteria

Pharmacological or Psychological treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Interpretation Bias Modification (IBM)	Interpretation Bias Modification (IBM)	Interpretation training intended to facilitating a more benign interpretation bias
Placebo	Control Condition	repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns.
Attention Bias Modification (ABM)	Attention Bias Modification Treatment (ABMT)	Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Attention and interpretation biases modification	Attention and Interpretive biases modification (CBM)	Attention and interpretation training intended to direct cognitive biases away from threat stimulus.

Primary Outcome Measures

Name	Time	Method
Social Anxiety Scale (LSAS) - diagnostic interview	Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols	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

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

Trial Locations

Locations (1)

Tel-Aviv University; 🇮🇱 Tel-Aviv, Israel