Attention Bias Modification Treatment in Social Anxiety

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Social Anxiety

Intervention / Treatment
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* Behavioral: Training away from threat
* Behavioral: Training towards threat
* Behavioral: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experiment 1: 2 groups (1 intervention and 1 placebo) receive treatment in parallel Experiment 2: 3 groups (2 types of intervention and 1 placebo) receive treatment in parallel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training away from threat<br>Experiment 1 and 2: In the intervention group -training away from threat-, in all angry-neutral faces presentation the probe is presented only after neutral face. Probe type (< or >) is not factorially counterbalanced but there is equal possibility of presentation for each of the following: angry-face location, probe location, or actor. Experiment 1: received 8 times (2 times per week for 4 weeks) Experiment 2: received 4 times (2 times for 2 weeks) | Behavioral: Training away from threat<br>* Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.<br>|
| Experimental: Training towards threat<br>Only for Experiment 2: The second ABMT condition -training towards threat- is identical to the first one with the exception that in all angry-neutral face presentations the symbol is presented only after threat face. In addition, at the beginning of every session participants will be informed that a random number of participants will have to repeat their speech. They will also be informed that this instruction will be given right after the dot probe task completion. This will be done in order for the participants to maintain their state anxiety but repetition of the speech task will not actually happen at this stage. Experiment 2: received 4 times (2 times for 2 weeks) | Behavioral: Training towards threat<br>* Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.<br>|
| Placebo Comparator: Placebo<br>Experiment 1 and 2: In the placebo group, angry-face location, probe location and actor are fully counterbalanced with regards to their presentation. Experiment 1: received 8 times (2 times per week for 4 weeks) Experiment 2: received 4 times (2 times for 2 weeks) | Behavioral: Placebo<br>* Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Anxiety levels | Experiment 1 & 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23. | Pre-treatment (day 1) | 
| Social Anxiety changes | Experiment 1 & 2: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23. | Experiment 1: 4 weeks after the day 1, Experiment 2: 3 weeks after the day 1 (Post-treatment) | 
| Social Anxiety changes | Only for experiment 1: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23. | 6 months after day 1 (Follow-up) | 
| Attentional Biases | 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). | Pre-treatment (day 1) | 
| Attentional Biases changes | 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). | 4 weeks after the day 1 (Post-treatment) | 
| Attentional Biases changes | Only for experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus). | 6 months after day 1 (Follow-up) | 
| Physical social anxiety levels | Only for experiment 2: measured through physiological measures, with the primary one to be heart rate. | Pre-treatment (day 1) | 
| Physical social anxiety changes | Only for experiment 2: measured through physiological measures, with the primary one to be heart rate. | 3 weeks after the day 1 (Post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Anxiety levels (clinical interview) | Experiment 1 & 2: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version. | Pre-treatment (day 1) | 
| Physical social anxiety levels 1 | Only for experiment 2: measured through skin conductance | Pre-treatment (day 1) | 
| Physical social anxiety levels 2 | Only for experiment 2: measured through corrugator supercilii | Pre-treatment (day 1) | 
| Social anxiety changes | Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version. | 4 weeks after the day 1 (Post-treatment) | 
| Physical social anxiety changes 1 | Only for experiment 2: measured through skin conductance | 3 weeks after the day 1 (Post-treatment) | 
| Social anxiety changes | Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version. | 6 months after day 1 (follow-up) | 
| Physical social anxiety changes 2 | Only for experiment 2: measured through corrugator supercilii | 3 weeks after the day 1 (Post-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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attention bias, treatment predictors