NCT03424967

Brief Summary

This study examines whether the ability to extract statistical properties from the environment among treatment-seeking patients with social anxiety disorder can predict therapeutic response to attention bias modification (ABM), namely, reduction in symptoms of social anxiety following ABM therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

February 1, 2018

Last Update Submit

February 1, 2018

Conditions

Keywords

attention-bias modificationstatistical learningsocial anxiety disordertreatment outcome

Outcome Measures

Primary Outcomes (1)

  • The Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores

    The Liebowitz Social Anxiety Scale is a clinician-rated inventory consisting of 24 items describing socially relevant situations. Each situation is rated in relation to the past week on two sub-scales ranging 0-3: level of fear and level of avoidance experienced in response to these situations. Item scores are summed to a total score ranging 0-144

    1-2 weeks after treatment completion

Secondary Outcomes (1)

  • The Social Phobia Inventory scores

    1-2 weeks after treatment completion

Study Arms (1)

ABM therapy

EXPERIMENTAL

The attention bias modification treatment comprises of six computerized sessions, twice a week, in purpose of modulate biases in attention for threat stimuli.

Behavioral: ABM

Interventions

ABMBEHAVIORAL

Participants are trained with a dot-probe task including angry-neutral faces. In 80% of trials the probe appears in place of the neutral face, and in 20% of trials in place of the angry face.

Also known as: attention bias modification
ABM therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a signed consent form
  • a primary diagnosis of social anxiety disorder
  • an age of 18-65

You may not qualify if:

  • any history or present diagnosis of psychosis
  • high risk for harm to self or others
  • concurrent posttraumatic stress disorder, eating disorder, or bipolar disorder
  • a diagnosis of a neurological disorder (i.e., epilepsy, brain injury)
  • drug or alcohol misuse
  • a pharmacological treatment that is not stabilized in the past 3 months
  • any concurrent psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Yair Bar-Haim, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

August 2, 2016

Primary Completion

June 12, 2017

Study Completion

June 12, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations