Attention Bias Modification Treatment in Social Anxiety

Social Anxiety Clinical Trial

— ABMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601377
• Other study ID #: ABMT University of Cyprus
• Status: Completed
• Phase: N/A
• Start date: October 3, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: University of Cyprus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 30, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
Cyprus	Department of Psychology, University of Cyprus	Nicosia

Sponsors (3)

Lead Sponsor	Collaborator
University of Cyprus	Tel Aviv University, Youth Board of Cyprus

Country where clinical trial is conducted

Cyprus, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Physical social anxiety levels	Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.	Pre-treatment (day 1)
Primary	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	Social Anxiety levels (clinical interview)	Experiment 1 & 2: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.	Pre-treatment (day 1)
Secondary	Physical social anxiety levels 1	Only for experiment 2: measured through skin conductance	Pre-treatment (day 1)
Secondary	Physical social anxiety levels 2	Only for experiment 2: measured through corrugator supercilii	Pre-treatment (day 1)
Secondary	Social anxiety changes	Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.	4 weeks after the day 1 (Post-treatment)
Secondary	Physical social anxiety changes 1	Only for experiment 2: measured through skin conductance	3 weeks after the day 1 (Post-treatment)
Secondary	Social anxiety changes	Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.	6 months after day 1 (follow-up)
Secondary	Physical social anxiety changes 2	Only for experiment 2: measured through corrugator supercilii	3 weeks after the day 1 (Post-treatment)