Clinical trial NCT03601377: Attention Bias Modification Treatment in Social Anxiety
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
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: attention bias
treatment predictors
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: Youth Board of Cyprus
name: Tel Aviv University
First posted: 2018-07-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Social Anxiety levels
timeFrame: Pre-treatment (day 1)
measure: Social Anxiety changes
timeFrame: Experiment 1: 4 weeks after the day 1, Experiment 2: 3 weeks after the day 1 (Post-treatment)
measure: Social Anxiety changes
timeFrame: 6 months after day 1 (Follow-up)
measure: Attentional Biases
timeFrame: Pre-treatment (day 1)
measure: Attentional Biases changes
timeFrame: 4 weeks after the day 1 (Post-treatment)
measure: Attentional Biases changes
timeFrame: 6 months after day 1 (Follow-up)
measure: Physical social anxiety levels
timeFrame: Pre-treatment (day 1)
measure: Physical social anxiety changes
timeFrame: 3 weeks after the day 1 (Post-treatment)
Secondary outcomes:
measure: Social Anxiety levels (clinical interview)
timeFrame: Pre-treatment (day 1)
measure: Physical social anxiety levels 1
timeFrame: Pre-treatment (day 1)
measure: Physical social anxiety levels 2
timeFrame: Pre-treatment (day 1)
measure: Social anxiety changes
timeFrame: 4 weeks after the day 1 (Post-treatment)
measure: Physical social anxiety changes 1
timeFrame: 3 weeks after the day 1 (Post-treatment)
measure: Social anxiety changes
timeFrame: 6 months after day 1 (follow-up)
measure: Physical social anxiety changes 2
timeFrame: 3 weeks after the day 1 (Post-treatment)
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Department of Psychology, University of Cyprus
Study officials:
affiliation: Associate Prof., Department of Psychology, University of Cyprus
name: Georgia Panayiotou, PhD
role: STUDY_DIRECTOR
References:
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.
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.