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Completed

NCT Number: NCT05018260

Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)

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Key information

Conditions

Social Anxiety Disorder (Social Phobia) Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders Social Anxiety Social Anxiety Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 55555, Israel

About this study

This study examines the possibility that the effectiveness shown for GC-MRT in the treatment of SAD leans on attention control rather than bias modification. Therefore half of the participants will receive the classic GC-MRT course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A signed consent form
  • Men and women between the ages of 18 and 65.
  • Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV.
  • SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders.
  • No current pharmaco-therapy.

Exclusion criteria

  • A diagnosis of psychotic or bipolar disorders.
  • A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
  • Drug or alcohol abuse.
  • Any current pharmacological treatment.
  • Any current psychotherapeutic treatment.
  • Change in treatment during the study.
  • Poor judgment capacity (i.e., children under 18 and special populations).

Treatment and study plan

Attention Bias Modification

Behavioral

Feedback according to participants' viewing patterns, in order to modify their attention bias to threat

Attention Control

Behavioral

Feedback according to participants' viewing patterns, in order to strengthen their attention control

Primary outcomes

  1. Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores

    Time frame: at baseline, one week after end of intervention

    The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. The minimum and maximum values of the LSAS total score are 0 and 144, respectively, with higher scores mean worse outcome. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern.

Secondary outcomes

  1. Change from baseline - the Social Phobia Inventory scores

    Time frame: at baseline, one week after end of intervention

    This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a total score ranging from 0 to 68. Higher scores mean worse outcome.

  2. Clinical Global Impression

    Time frame: at baseline, one week after end of intervention

    A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. Higher scores mean worse outcome.

Other outcomes

  1. Change from baseline -Attention Control Scale- ACS

    Time frame: at baseline, one week after end of intervention

    The Attention Control Scale (ACS) assesses attention control, using 20 items rated from 1 to 4. The total score ranging from 20 to 80, with higher scores mean better outcome.

  2. Change from baseline - Patient Health Questionnaire- PHQ9

    Time frame: at baseline, one week after end of intervention

    The Patient Health Questionnaire (PHQ9) assesses depressive symptoms using a self-report, 9 question questionnaire. Items are rated on a scale of 0-3 representing the frequency of depressive symptoms over the past 2 weeks. Scores range between 0 to 27, with higher scores mean worse outcome.

  3. Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias.

    Time frame: at baseline, one week after end of intervention

    gaze patterns measured using an established eye tracking task, measuring dwell time on different types of stimuli within a 4X4 matrix.

  4. reaction times on the Flanker task, representing attention control

    Time frame: at baseline, one week after end of intervention

    attention control will be measured using the established Flanker test, to assess change from baseline following treatment.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2021
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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