Gaze Contingent Feedback in Social Anxiety Disorder

Phobia, Social Clinical Trial

Official title:

Gaze Contingent Feedback in Treatment of SAD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590770
• Other study ID #: TAUSAD
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: July 27, 2016
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobia, Social
• Phobic Disorders

Intervention

Behavioral:
• attention modification
participants will receive gaze-continent feedback according to their viewing patterns

Other:
• Placebo
participants will receive non-gaze-continent feedback unrelated to their viewing patterns

Locations

Country	Name	City	State
Israel	Tel-Aviv University	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis	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.	post treatment (1 week after treatment completion)	No
Primary	Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores	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.	post treatment (1 week after treatment completion) and 3-month follow up	No
Secondary	Change from baseline - the Social Phobia Inventory scores	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.	post treatment (1 week after treatment completion) and 3-month follow up	No