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CompletedNCT03424967Updated Feb 7, 2018

Statistical Learning as a Predictor of Attention Bias Modification Outcome

An interventional study of ABM in Social Anxiety Disorder, sponsored by Tel Aviv University. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the detailed description

All participants received 6 sessions of ABM therapy away from threat. At baseline participants also completed a gold standard statistical learning task aimed to assess participants' capacity for the extraction of statistical regularity from the environment. The aim of the study is to determine whether the basic ability to extract rules from the environment at baseline could predict clinical improvement of social anxiety symptoms.

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Conditions studied

  • Social Anxiety Disorder

Keywords

  • attention-bias modification
  • statistical learning
  • social anxiety disorder
  • treatment outcome
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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    ABM therapy

    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

  • BehavioralABM

    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

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What researchers measure

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

    Time frame: 1-2 weeks after treatment completion

Secondary outcomes

  1. The Social Phobia Inventory scores

    The Social Phobia Inventory is a self-reported questionnaire comprised of 17 items on a 5-point scale depicting social worries and problems. Participants rate to what extent these situations have bothered them in the past week. Item scores are summed to a total score ranging 0-68.

    Time frame: 1-2 weeks after treatment completion

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Study locations

1 site
  • Tel Aviv University
    Tel Aviv, 6997801, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03424967
Lead sponsor
Tel Aviv University
Responsible party
Yair Bar-Haim (Professor, Tel Aviv University) — Principal investigator
First posted
Feb 7, 2018
Start date
Aug 2, 2016
Primary completion
Jun 12, 2017
Completion
Jun 12, 2017
Last update
Feb 7, 2018

Study contacts

Yair Bar-Haim, PhD
principal investigator · Tel Aviv University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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