Cognitive Biases Modification Treatment for Social Anxiety

NCT01503151 | Completed Phase 2

• 1 other identifier: CBM_SP_2012
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Phobia

Keywords

attention bias modification treatment; interpretive bias modification; cognitive bias modification; attention training; social anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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 Bias Modification (ABM)

EXPERIMENTAL

Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.

Behavioral: Attention Bias Modification Treatment (ABMT)

Interpretation Bias Modification (IBM)

EXPERIMENTAL

Interpretation training intended to facilitating a more benign interpretation bias

Behavioral: Interpretation Bias Modification (IBM)

Attention and interpretation biases modification

EXPERIMENTAL

Attention and interpretation training intended to direct cognitive biases away from threat stimulus.

Behavioral: Attention and Interpretive biases modification (CBM)

Interventions

Attention Bias Modification Treatment (ABMT) BEHAVIORAL

Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.

Attention Bias Modification (ABM)

Interpretation Bias Modification (IBM) BEHAVIORAL

Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.

Interpretation Bias Modification (IBM)

Control Condition BEHAVIORAL

Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.

Placebo

Attention and Interpretive biases modification (CBM) BEHAVIORAL

Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.

Attention and interpretation biases modification

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People suffering from social anxiety

You may not qualify if:

• Pharmacological or Psychological treatment

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 2, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

IL (1)