Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Gaze Contingent Music Reward Therapy
Escitalopram
Waitlist
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- A signed consent form
- Men and women between the ages of 18 and 65.
- Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV.
- 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.
- No current pharmaco-therapy.
Exclusion Criteria:
- A diagnosis of psychotic or bipolar disorders.
- A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- Drug or alcohol abuse.
- Any current pharmacological treatment.
- Any current psychotherapeutic treatment.
- Change in treatment during the study.
- 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 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Gaze Contingent Music Reward Therapy
Selective Serotonin Reuptake Inhibitors
Waitlist Control
Arm Description
Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.
Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.
Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.
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.
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.
Clinical Global Impression
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.
Full Information
NCT ID
NCT03346239
First Posted
November 9, 2017
Last Updated
January 31, 2022
Sponsor
Tel Aviv University
Collaborators
Sheba Medical Center, Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03346239
Brief Title
Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
Official Title
Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
Collaborators
Sheba Medical Center, Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the clinical efficacy and neuro-cognitive mechanisms of Gaze-Contingent Usic Reward Therapy for social anxiety disorder, compared with treatment with SSRIs or waitlist control.
Detailed Description
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for social anxiety disorder, compared to treatment with SSRI (Escitelopram) and a waitlist control. A secondary purpose is to explore the unique neuro-cognitive mechanisms of this treatment, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using clinical interviews and self-rated questionnaires before, during and after 12 weeks of treatment or wait. Outcome measures will be social anxiety symptoms, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and BOLD signals in MRI measurements. Neuro-cognitive mechanisms will be explored as potential mediators of clinical efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gaze Contingent Music Reward Therapy
Arm Type
Experimental
Arm Description
Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.
Arm Title
Selective Serotonin Reuptake Inhibitors
Arm Type
Active Comparator
Arm Description
Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.
Arm Title
Waitlist Control
Arm Type
Placebo Comparator
Arm Description
Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Gaze Contingent Music Reward Therapy
Intervention Description
Feedback according to participants' viewing patterns, in order to modify their attention.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Cipralex
Intervention Description
10-20 mg of Escitalopram
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.
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.
Time Frame
6 weeks into intervention, 1 week after intervention completion
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.
Time Frame
At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion
Title
Clinical Global Impression
Description
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.
Time Frame
6 weeks into intervention, 1 week after intervention completion
Other Pre-specified Outcome Measures:
Title
Change from baseline - the Patient Health Questionnaire (PHQ)- a measure of depression
Description
Depression levels at pre and posttreatment and their change from baseline were used as moderators for clinical outcome
Time Frame
at baseline, one week after end of intervention
Title
Change from baseline - viewing patterns on threat-neutral face matrices
Description
gaze patterns, and specifically attention allocation to threat, at pre, mid and posttreatment and their change from baseline were used as moderators for clinical outcome, as well as indicators of target engagement for the GCMRT group. This is done using an established eye-tracking task (Lazarov et al, 2016). Data will also be extracted from the training sessions of GC-MRT participants to evaluate change during treatment.
Time Frame
at baseline, 6 weeks into intervention and one week after end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A signed consent form
Men and women between the ages of 18 and 65.
Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV.
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.
No current pharmaco-therapy.
Exclusion Criteria:
A diagnosis of psychotic or bipolar disorders.
A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
Drug or alcohol abuse.
Any current pharmacological treatment.
Any current psychotherapeutic treatment.
Change in treatment during the study.
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
Plan to Share IPD
No
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Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
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