Cognitive Biases Modification Treatment for Social Anxiety

Social Phobia Clinical Trial

— CBMSP  

Official title:

Cognitive Biases Modification Treatment for Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503151
• Other study ID #: CBM_SP_2012
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2011
• Last updated: December 1, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Tel Aviv University Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Social Phobia

Intervention

Behavioral:
• Attention Bias Modification Treatment (ABMT)
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
• Interpretation Bias Modification (IBM)
Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
• Control Condition
Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
• 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.

Locations

Country	Name	City	State
Israel	Tel-Aviv University	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No