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Attention Bias Modification Treatment in Social Anxiety

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03601377
Acronym
ABMT
Enrollment
140
Registered
2018-07-26
Start date
2016-10-03
Completion date
2018-09-30
Last updated
2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety

Keywords

attention bias, treatment predictors

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.

Interventions

BEHAVIORALTraining 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.

BEHAVIORALTraining 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.

BEHAVIORALPlacebo

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.

Sponsors

Youth Board of Cyprus
CollaboratorUNKNOWN
Tel Aviv University
CollaboratorOTHER
University of Cyprus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants and investigators were blind with regards to which group participants were allocated.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical social anxiety changes3 weeks after the day 1 (Post-treatment)Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Social Anxiety levelsPre-treatment (day 1)Experiment 1 & 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23.
Social Anxiety changesExperiment 1: 4 weeks after the day 1, Experiment 2: 3 weeks after the day 1 (Post-treatment)Experiment 1 & 2: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Attentional BiasesPre-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 changes4 weeks after the day 1 (Post-treatment)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).
Physical social anxiety levelsPre-treatment (day 1)Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.

Secondary

MeasureTime frameDescription
Social Anxiety levels (clinical interview)Pre-treatment (day 1)Experiment 1 & 2: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Physical social anxiety levels 1Pre-treatment (day 1)Only for experiment 2: measured through skin conductance
Physical social anxiety levels 2Pre-treatment (day 1)Only for experiment 2: measured through corrugator supercilii
Social anxiety changes4 weeks after the day 1 (Post-treatment)Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Physical social anxiety changes 13 weeks after the day 1 (Post-treatment)Only for experiment 2: measured through skin conductance
Physical social anxiety changes 23 weeks after the day 1 (Post-treatment)Only for experiment 2: measured through corrugator supercilii

Countries

Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026