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Cognitive Biases Modification Treatment for Social Anxiety (CBMSP)

Primary Purpose

Social Phobia

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Attention Bias Modification Treatment (ABMT)
Interpretation Bias Modification (IBM)
Control Condition
Attention and Interpretive biases modification (CBM)
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Social Phobia focused on measuring attention bias modification treatment, interpretive bias modification, cognitive bias modification, attention training, social anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment

Sites / Locations

  • Tel-Aviv University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Attention Bias Modification (ABM)

Interpretation Bias Modification (IBM)

Attention and interpretation biases modification

Arm Description

repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns.

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

Interpretation training intended to facilitating a more benign interpretation bias

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
December 29, 2011
Last Updated
December 1, 2014
Sponsor
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT01503151
Brief Title
Cognitive Biases Modification Treatment for Social Anxiety
Acronym
CBMSP
Official Title
Cognitive Biases Modification Treatment for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
attention bias modification treatment, interpretive bias modification, cognitive bias modification, attention training, social anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns.
Arm Title
Attention Bias Modification (ABM)
Arm Type
Experimental
Arm Description
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Arm Title
Interpretation Bias Modification (IBM)
Arm Type
Experimental
Arm Description
Interpretation training intended to facilitating a more benign interpretation bias
Arm Title
Attention and interpretation biases modification
Arm Type
Experimental
Arm Description
Attention and interpretation training intended to direct cognitive biases away from threat stimulus.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification Treatment (ABMT)
Intervention Description
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
Intervention Type
Behavioral
Intervention Name(s)
Interpretation Bias Modification (IBM)
Intervention Description
Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
Intervention Type
Behavioral
Intervention Name(s)
Attention and Interpretive biases modification (CBM)
Intervention Description
Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.
Primary Outcome Measure Information:
Title
Social Anxiety Scale (LSAS) - diagnostic interview
Description
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.
Time Frame
Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols
Secondary Outcome Measure Information:
Title
The Mini International Neuropsychiatric Interview (MINI).
Description
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)
Time Frame
expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People suffering from social anxiety Exclusion Criteria: Pharmacological or Psychological treatment
Facility Information:
Facility Name
Tel-Aviv University
City
Tel-Aviv
Country
Israel

12. IPD Sharing Statement

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Cognitive Biases Modification Treatment for Social Anxiety

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