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Clinical Trials/NCT03601377
NCT03601377
Completed
N/A

Attention Bias Modification Treatment in Social Anxiety: Avoidance or Exposure to Threatening Faces? The Role of Pre-existing Attentional Biases and State Anxiety

University of Cyprus1 site in 1 country140 target enrollmentOctober 3, 2016
ConditionsSocial Anxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Social Anxiety
Sponsor
University of Cyprus
Enrollment
140
Locations
1
Primary Endpoint
Social Anxiety changes
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study evaluates attention modification in social anxiety and It is comprised by 2 experiments. At experiment 1 socially anxious participants will receive either training away from threatening faces or placebo intervention and at experiment 2 they will receive either one of these 2 groups or training towards threatening faces. At experiment 2 training will be done under state anxiety levels (video-recording of a speech). Anxiety levels (self-reports, physiological and behavioral measures) as well as attentional biases changes will be examined at pre and post - intervention levels plus 6 months follow-up only for experiment 1.

Detailed Description

Social anxiety is a highly prevalent disorder in the population. Even though there are effective interventions that can help people who suffer from it, many of them do not seek or receive an evidence-based, face to face treatment. According to cognitive models, attention to social threat is one of the principles that maintain social anxiety. In fact, individuals with social anxiety present attention bias to threat stimuli. However, there is inconsistency in the literature with regards to attentional biases that individuals with anxiety present. A recent model is the vigilance-avoidance hypothesis, in which socially anxious initially focus on the threat and then they avoid it. Therefore, better understanding and then aiming to modify these attentional biases in a computerized manner, with minimal therapist interaction can be a novel and promising way to treat social anxiety, even among patients who avoid presenting for therapy. Two experiments are aiming to shed some light with regards to the effect of attention bias modification treatment in individuals with social anxiety, taking into consideration the previous mixed results. The first experiment compares training attention to be directed away from threat with a placebo treatment. Approximately 60 socially anxious individuals are randomly allocated in the 2 groups. A structured interview and self-report assessment are done pre-treatment, post-treatment and 6 months follow-up. The second experiment adds a third group of training towards threat (i.e. exposure), investigating if changing attentional avoidance can also affect anxiety levels. Moreover, the second experiment attempts to improve the typical attention modification paradigm by targeting treatment to participants' identified pre-experimental attentional biases. In addition, predictors of treatment effectiveness will be studied and particularly pre-intervention attentional biases as well as state anxiety. Participants are approximately 90 adults with social phobia who are randomly allocated in treatment and placebo groups. In experiment 2 participants will also be assessed behaviourally as well as physiologically to better demonstrate that anxiety reactions to anxiogenic situations have been reduced between pre and post treatment and that they are smaller than those of a placebo control group. It is expected that participants in the intervention groups will show reduced attentional bias and social anxiety symptoms in comparison with the placebo group in both studies. In addition, the kind of pre-intervention bias as well as state anxiety will moderate anxiety changes. This study will enrich existing research on attention bias modification treatment by shedding light into potential mechanisms of change and will examine ways to improve the efficacy of this intervention.

Registry
clinicaltrials.gov
Start Date
October 3, 2016
End Date
September 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Klavdia Neophytou

PhD Clinical Psychology Student

University of Cyprus

Eligibility Criteria

Inclusion Criteria

  • highly socially anxious students (based on self-report questionnaire)

Exclusion Criteria

  • suicidal intent,
  • substance abuse,
  • primary diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder,
  • or past schizophrenia, bipolar disorder, organic mental disorder,
  • any concurrent psychotherapy,
  • changes in medication during the 12 weeks prior to study and
  • CBT therapy 6 months before the beginning of treatment.

Outcomes

Primary Outcomes

Social Anxiety changes

Time Frame: 6 months after day 1 (Follow-up)

Only for experiment 1: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.

Social Anxiety levels

Time Frame: Pre-treatment (day 1)

Experiment 1 \& 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23.

Attentional Biases

Time Frame: Pre-treatment (day 1)

For experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus). For experiment 2: Assess kind of attentional biases using the eye-tracking task (measuring eye gaze).

Attentional Biases changes

Time Frame: 6 months after day 1 (Follow-up)

Only for experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus).

Physical social anxiety levels

Time Frame: Pre-treatment (day 1)

Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.

Physical social anxiety changes

Time Frame: 3 weeks after the day 1 (Post-treatment)

Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.

Secondary Outcomes

  • Social Anxiety levels (clinical interview)(Pre-treatment (day 1))
  • Social anxiety changes(6 months after day 1 (follow-up))
  • Physical social anxiety levels 1(Pre-treatment (day 1))
  • Physical social anxiety changes 1(3 weeks after the day 1 (Post-treatment))
  • Physical social anxiety levels 2(Pre-treatment (day 1))
  • Physical social anxiety changes 2(3 weeks after the day 1 (Post-treatment))

Study Sites (1)

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