Gaze Contingent Feedback in Social Anxiety Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02590770
• Date of registration: 27/10/2015
• Prospective Registration: No
• Primary sponsor: Tel Aviv University
• Public title: Gaze Contingent Feedback in Social Anxiety Disorder
• Scientific title: Gaze Contingent Feedback in Treatment of SAD
• Date of first enrolment: October 2015
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02590770
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Yair Bar-Haim, PhD
• Affiliation: Tel Aviv University

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Phobia, Social

Intervention(s)

Behavioral: attention modification

Other: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

Change from baseline - the Social Phobia Inventory scores [Time Frame: post treatment (1 week after treatment completion) and 3-month follow up]

Secondary ID(s)

TAUSAD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors