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Gaze Contingent Feedback in Social Anxiety Disorder

Primary Purpose

Phobia, Social

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
attention modification
Placebo
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phobia, Social

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tel-Aviv University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

gaze-contingent

non-gaze contingent

Arm Description

attention modification: participants will receive gaze-contingent feedback according to their viewing patterns

Placebo: participants will receive non-gaze-contingent feedback according to their viewing patterns

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 27, 2015
Last Updated
July 27, 2016
Sponsor
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT02590770
Brief Title
Gaze Contingent Feedback in Social Anxiety Disorder
Official Title
Gaze Contingent Feedback in Treatment of SAD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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)
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia, Social

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gaze-contingent
Arm Type
Active Comparator
Arm Description
attention modification: participants will receive gaze-contingent feedback according to their viewing patterns
Arm Title
non-gaze contingent
Arm Type
Placebo Comparator
Arm Description
Placebo: participants will receive non-gaze-contingent feedback according to their viewing patterns
Intervention Type
Behavioral
Intervention Name(s)
attention modification
Intervention Description
participants will receive gaze-continent feedback according to their viewing patterns
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
participants will receive non-gaze-continent feedback unrelated to their viewing patterns
Primary Outcome Measure Information:
Title
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
Description
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.
Time Frame
post treatment (1 week after treatment completion) and 3-month follow up
Secondary Outcome Measure Information:
Title
Change from baseline - the Social Phobia Inventory scores
Description
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.
Time Frame
post treatment (1 week after treatment completion) and 3-month follow up
Other Pre-specified Outcome Measures:
Title
changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis
Description
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.
Time Frame
post treatment (1 week after treatment completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv University
City
Tel-Aviv
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
28103714
Citation
Lazarov A, Pine DS, Bar-Haim Y. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. Am J Psychiatry. 2017 Jul 1;174(7):649-656. doi: 10.1176/appi.ajp.2016.16080894. Epub 2017 Jan 20.
Results Reference
derived

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Gaze Contingent Feedback in Social Anxiety Disorder

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