Attention Bias Modification Treatment in Social Anxiety (ABMT)

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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Behavioral: Training away from threat; Behavioral: Training towards threat; Behavioral: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus, 1678
    • Department of Psychology, University of Cyprus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training away from threat; 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; 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.
Experimental: Training towards threat; 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; 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.
Placebo Comparator: Placebo; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Cyprus
• Collaborators: Tel Aviv University; Youth Board of Cyprus
• Investigators: Study Director: Georgia Panayiotou, PhD, Associate Prof., Department of Psychology, University of Cyprus

Publications and helpful links

General Publications

• Bar-Haim Y. Research review: Attention bias modification (ABM): a novel treatment for anxiety disorders. J Child Psychol Psychiatry. 2010 Aug;51(8):859-70. doi: 10.1111/j.1469-7610.2010.02251.x. Epub 2010 May 6.
• Amir N, Beard C, Taylor CT, Klumpp H, Elias J, Burns M, Chen X. Attention training in individuals with generalized social phobia: A randomized controlled trial. J Consult Clin Psychol. 2009 Oct;77(5):961-973. doi: 10.1037/a0016685.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: attention bias; treatment predictors
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ABMT University of Cyprus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No