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Attention Bias Modification Treatment in Social Anxiety (ABMT)

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Training away from threat
Training towards threat
Placebo
Sponsored by
University of Cyprus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety focused on measuring attention bias, treatment predictors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychology, University of Cyprus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Training away from threat

Training towards threat

Placebo

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Social Anxiety levels
Experiment 1 & 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23.
Social Anxiety changes
Experiment 1 & 2: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Social Anxiety changes
Only for experiment 1: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
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).
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).
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).
Physical social anxiety levels
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Physical social anxiety changes
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.

Secondary Outcome Measures

Social Anxiety levels (clinical interview)
Experiment 1 & 2: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Physical social anxiety levels 1
Only for experiment 2: measured through skin conductance
Physical social anxiety levels 2
Only for experiment 2: measured through corrugator supercilii
Social anxiety changes
Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Physical social anxiety changes 1
Only for experiment 2: measured through skin conductance
Social anxiety changes
Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Physical social anxiety changes 2
Only for experiment 2: measured through corrugator supercilii

Full Information

First Posted
June 6, 2018
Last Updated
October 26, 2018
Sponsor
University of Cyprus
Collaborators
Youth Board of Cyprus, Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT03601377
Brief Title
Attention Bias Modification Treatment in Social Anxiety
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cyprus
Collaborators
Youth Board of Cyprus, Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
attention bias, treatment predictors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Participants and investigators were blind with regards to which group participants were allocated.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training away from threat
Arm Type
Experimental
Arm Description
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)
Arm Title
Training towards threat
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Training away from threat
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training towards threat
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social Anxiety levels
Description
Experiment 1 & 2: self-reported questionnaires, with the primary one to be Social Phobia and Anxiety Inventory-23.
Time Frame
Pre-treatment (day 1)
Title
Social Anxiety changes
Description
Experiment 1 & 2: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Time Frame
Experiment 1: 4 weeks after the day 1, Experiment 2: 3 weeks after the day 1 (Post-treatment)
Title
Social Anxiety changes
Description
Only for experiment 1: Measured in self-reported questionnaires with the primary one to be Social Phobia and Anxiety Inventory-23.
Time Frame
6 months after day 1 (Follow-up)
Title
Attentional Biases
Description
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).
Time Frame
Pre-treatment (day 1)
Title
Attentional Biases changes
Description
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).
Time Frame
4 weeks after the day 1 (Post-treatment)
Title
Attentional Biases changes
Description
Only for experiment 1: Assess kind of attentional biases using the dot-probe task (comparison of reaction time to threatening and a neutral stimulus).
Time Frame
6 months after day 1 (Follow-up)
Title
Physical social anxiety levels
Description
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Time Frame
Pre-treatment (day 1)
Title
Physical social anxiety changes
Description
Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.
Time Frame
3 weeks after the day 1 (Post-treatment)
Secondary Outcome Measure Information:
Title
Social Anxiety levels (clinical interview)
Description
Experiment 1 & 2: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Time Frame
Pre-treatment (day 1)
Title
Physical social anxiety levels 1
Description
Only for experiment 2: measured through skin conductance
Time Frame
Pre-treatment (day 1)
Title
Physical social anxiety levels 2
Description
Only for experiment 2: measured through corrugator supercilii
Time Frame
Pre-treatment (day 1)
Title
Social anxiety changes
Description
Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Time Frame
4 weeks after the day 1 (Post-treatment)
Title
Physical social anxiety changes 1
Description
Only for experiment 2: measured through skin conductance
Time Frame
3 weeks after the day 1 (Post-treatment)
Title
Social anxiety changes
Description
Experiment 1: measured through clinical interview, Anxiety Disorders Interview Schedule (ADIS) adult version.
Time Frame
6 months after day 1 (follow-up)
Title
Physical social anxiety changes 2
Description
Only for experiment 2: measured through corrugator supercilii
Time Frame
3 weeks after the day 1 (Post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia Panayiotou, PhD
Organizational Affiliation
Associate Prof., Department of Psychology, University of Cyprus
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychology, University of Cyprus
City
Nicosia
ZIP/Postal Code
1678
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19803575
Citation
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.
Results Reference
background
PubMed Identifier
20456540
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.
Results Reference
background

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Attention Bias Modification Treatment in Social Anxiety

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