Attention Bias Modification Treatment in Social Anxiety (ABMT)

University of Cyprus

Status: Completed

Conditions: Social Anxiety

Treatments: Behavioral: Placebo; Behavioral: Training away from threat; Behavioral: Training towards threat

Study type: Interventional

Funder types: Other

Identifiers

NCT03601377

ABMT University of Cyprus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 3 patient groups, including a placebo group

Training away from threat

Experimental group

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)

Treatment:

Behavioral: Training away from threat

Training towards threat

Experimental group

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)

Treatment:

Behavioral: Training towards threat

Placebo

Placebo Comparator group

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)

Treatment:

Behavioral: Placebo