NCT03601377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

June 6, 2018

Last Update Submit

October 26, 2018

Conditions

Social Anxiety

Keywords

attention biastreatment predictors

Outcome Measures

Primary Outcomes (8)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Physical social anxiety levels

    Only for experiment 2: measured through physiological measures, with the primary one to be heart rate.

    Pre-treatment (day 1)

  • 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 Outcomes (7)

  • Social Anxiety levels (clinical interview)

    Pre-treatment (day 1)

  • Physical social anxiety levels 1

    Pre-treatment (day 1)

  • Physical social anxiety levels 2

    Pre-treatment (day 1)

  • Social anxiety changes

    4 weeks after the day 1 (Post-treatment)

  • Physical social anxiety changes 1

    3 weeks after the day 1 (Post-treatment)

  • +2 more secondary outcomes

Study Arms (3)

Training away from threat

EXPERIMENTAL

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)

Behavioral: Training away from threat

Training towards threat

EXPERIMENTAL

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)

Behavioral: Training towards threat

Placebo

PLACEBO COMPARATOR

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)

Behavioral: Placebo

Interventions

Training away from threatBEHAVIORAL

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 away from threat
Training towards threatBEHAVIORAL

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
PlaceboBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) highly socially anxious students (based on self-report questionnaire)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Cyprus

Nicosia, 1678, Cyprus

Location

Related 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.

    PMID: 19803575BACKGROUND

  • 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.

    PMID: 20456540BACKGROUND

Study Officials

  • Georgia Panayiotou, PhD

    Associate Prof., Department of Psychology, University of Cyprus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and investigators were blind with regards to which group participants were allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Clinical Psychology Student

Study Record Dates

First Submitted

June 6, 2018

First Posted

July 26, 2018

Study Start

October 3, 2016

Primary Completion

July 31, 2018

Study Completion

September 30, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CY(1)