Phobia, Social Clinical Trial
Official title:
Gaze Contingent Feedback in Treatment of SAD
Verified date | July 2016 |
Source | Tel Aviv University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
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)
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Tel-Aviv University | Tel-Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel Aviv University |
Israel,
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 |
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