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Completed

NCT Number: NCT02590770

Gaze Contingent Feedback in Social Anxiety Disorder

The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)

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Key information

Conditions

Phobia, Social Anxiety Disorders Mental Disorders Phobic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel-Aviv University

Tel Aviv, Israel

About this study

The study examines giving social anxious participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.

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 60.
  • Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
  • A minimum of a 1-year duration of SP
  • 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
  • Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

Exclusion criteria

  • Psychotic episode in the past or the present time.
  • Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
  • Another psychotherapeutic treatment during the study.
  • Usage of neuroleptic medication.
  • Change in medication status during the study.
  • Substantial usage of drugs or alcohol in the present time.
  • Poor judgment capacity (i.e., children under 18 and special populations).

Treatment and study plan

attention modification

Behavioral

participants will receive gaze-continent feedback according to their viewing patterns

Placebo

Other

participants will receive non-gaze-continent feedback unrelated to their viewing patterns

Primary outcomes

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

    Time frame: post treatment (1 week after treatment completion) and 3-month follow up

    The 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. 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. It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability.

Secondary outcomes

  1. Change from baseline - the Social Phobia Inventory scores

    Time frame: post treatment (1 week after treatment completion) and 3-month follow up

    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 possible total score of 68. The SPIN has been used in clinical and nonclinical samples and its psychometric properties have been found to be sound.

Other outcomes

  1. changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis

    Time frame: post treatment (1 week after treatment completion)

    a structured diagnostic interview for DSM - IV and ICD-10 psychiatric disorders, which takes approximately 20 min to administer and is a valid and time-efficient alternative to the SCID-P and CIDI.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Gaze Contingent Feedback in Treatment of SAD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2015
Registry last updated
Jul 28, 2016

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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