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A Novel Computer-Based Therapy for Social Anxiety

Primary Purpose

Social Anxiety Disorder

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GC-MRT
modified GC-MRT
Non-GC-MRT
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Social Anxiety Disorder focused on measuring Social Anxiety, Social Anxiety Disorder, SAD

Eligibility Criteria

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

Inclusion Criteria:

  • Males and females between the ages of 18 and 60
  • Current DSM-V primary diagnosis of SAD
  • Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
  • Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol
  • Normal or corrected-to-normal vision

Exclusion Criteria:

  • Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
  • Current severe depression
  • Suicidal ideation or behavior
  • Current diagnosis of PTSD, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
  • Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
  • Current unstable or untreated medical illness
  • Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed)
  • Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
  • Any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months
  • Pregnancy, or plans to become pregnant during the period of the study - will be assessed by Urine β-HCG
  • Contraindication to MRI scanning:
  • Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
  • Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

GC-MRT

non-GC-MRT

GC-MRT-modified

Arm Description

Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT

Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT

Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT.

Outcomes

Primary Outcome Measures

Liebowitz Social Anxiety Scale
Total score of the Liebowitz Social Anxiety Scale

Secondary Outcome Measures

Social Phobia Inventory (SPIN)
The Social Phobia Inventory (abbreviated as SPIN) is a self-rated questionnaire that will be used to assess severity of social anxiety Disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety).
Quality of Life Enjoyment & Satisfaction Questionnaire
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Revised Social Anhedonia Scale
40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia).
Snaith Hamilton Pleasure Scale
Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
Hamilton Rating Scale for Depression - 17 item version
Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).
Clinical Global Impression-Change Scale
Clinical Global Impression-Change Scale: A quickly administered and widely used observer rating, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.

Full Information

First Posted
July 25, 2017
Last Updated
January 20, 2023
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03240003
Brief Title
A Novel Computer-Based Therapy for Social Anxiety
Official Title
A Novel Computer-Based Therapy for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
funding unavailable
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD)
Detailed Description
The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions twice a week for 4 weeks, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using a scan called magnetic resonance imaging (MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety, Social Anxiety Disorder, SAD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GC-MRT
Arm Type
Experimental
Arm Description
Group 1 will receive a 4-week (8-sessions) course of standard GC-MRT
Arm Title
non-GC-MRT
Arm Type
Active Comparator
Arm Description
Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT
Arm Title
GC-MRT-modified
Arm Type
Experimental
Arm Description
Group 3 will receive a 4-week (8-sessions) course of modified GC-MRT.
Intervention Type
Behavioral
Intervention Name(s)
GC-MRT
Intervention Description
Group 1 will receive a 4-week (8-sessions) course of GC-MRT
Intervention Type
Behavioral
Intervention Name(s)
modified GC-MRT
Intervention Description
group 3 will receive a 4-week (8-sessions) course of GC-MRT, modified
Intervention Type
Behavioral
Intervention Name(s)
Non-GC-MRT
Intervention Description
Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT
Primary Outcome Measure Information:
Title
Liebowitz Social Anxiety Scale
Description
Total score of the Liebowitz Social Anxiety Scale
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Social Phobia Inventory (SPIN)
Description
The Social Phobia Inventory (abbreviated as SPIN) is a self-rated questionnaire that will be used to assess severity of social anxiety Disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety).
Time Frame
4 months
Title
Quality of Life Enjoyment & Satisfaction Questionnaire
Description
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Time Frame
4 months
Title
Revised Social Anhedonia Scale
Description
40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia).
Time Frame
4 months
Title
Snaith Hamilton Pleasure Scale
Description
Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
Time Frame
4 months
Title
Hamilton Rating Scale for Depression - 17 item version
Description
Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).
Time Frame
4 months
Title
Clinical Global Impression-Change Scale
Description
Clinical Global Impression-Change Scale: A quickly administered and widely used observer rating, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.
Time Frame
4 months

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: Males and females between the ages of 18 and 60 Current DSM-V primary diagnosis of SAD Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version) Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol Normal or corrected-to-normal vision Exclusion Criteria: Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder Current severe depression Suicidal ideation or behavior Current diagnosis of PTSD, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder Current or past organic mental disorder, seizure disorder, epilepsy or brain injury Current unstable or untreated medical illness Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed) Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months Any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months Pregnancy, or plans to become pregnant during the period of the study - will be assessed by Urine β-HCG Contraindication to MRI scanning: Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos) Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Schneier, MD
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27907025
Citation
Chevallier C, Tonge N, Safra L, Kahn D, Kohls G, Miller J, Schultz RT. Measuring Social Motivation Using Signal Detection and Reward Responsiveness. PLoS One. 2016 Dec 1;11(12):e0167024. doi: 10.1371/journal.pone.0167024. eCollection 2016.
Results Reference
background
PubMed Identifier
20005616
Citation
Cisler JM, Koster EH. Mechanisms of attentional biases towards threat in anxiety disorders: An integrative review. Clin Psychol Rev. 2010 Mar;30(2):203-16. doi: 10.1016/j.cpr.2009.11.003. Epub 2009 Dec 14.
Results Reference
background
PubMed Identifier
12169250
Citation
Gur RC, Schroeder L, Turner T, McGrath C, Chan RM, Turetsky BI, Alsop D, Maldjian J, Gur RE. Brain activation during facial emotion processing. Neuroimage. 2002 Jul;16(3 Pt 1):651-62. doi: 10.1006/nimg.2002.1097.
Results Reference
background
PubMed Identifier
26080314
Citation
Heeren A, Mogoase C, Philippot P, McNally RJ. Attention bias modification for social anxiety: A systematic review and meta-analysis. Clin Psychol Rev. 2015 Aug;40:76-90. doi: 10.1016/j.cpr.2015.06.001. Epub 2015 Jun 6.
Results Reference
background
PubMed Identifier
22425719
Citation
Klumpp H, Angstadt M, Phan KL. Shifting the focus of attention modulates amygdala and anterior cingulate cortex reactivity to emotional faces. Neurosci Lett. 2012 Apr 18;514(2):210-3. doi: 10.1016/j.neulet.2012.03.003. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
23547713
Citation
Klumpp H, Post D, Angstadt M, Fitzgerald DA, Phan KL. Anterior cingulate cortex and insula response during indirect and direct processing of emotional faces in generalized social anxiety disorder. Biol Mood Anxiety Disord. 2013 Apr 2;3:7. doi: 10.1186/2045-5380-3-7. eCollection 2013.
Results Reference
background
PubMed Identifier
26774515
Citation
Lazarov A, Abend R, Bar-Haim Y. Social anxiety is related to increased dwell time on socially threatening faces. J Affect Disord. 2016 Mar 15;193:282-8. doi: 10.1016/j.jad.2016.01.007. Epub 2016 Jan 12.
Results Reference
background
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
background
PubMed Identifier
25708991
Citation
Linetzky M, Pergamin-Hight L, Pine DS, Bar-Haim Y. Quantitative evaluation of the clinical efficacy of attention bias modification treatment for anxiety disorders. Depress Anxiety. 2015 Jun;32(6):383-91. doi: 10.1002/da.22344. Epub 2015 Feb 24. Erratum In: Depress Anxiety. 2018 Jan;35(1):111-112.
Results Reference
background
PubMed Identifier
24652823
Citation
Mogoase C, David D, Koster EH. Clinical efficacy of attentional bias modification procedures: an updated meta-analysis. J Clin Psychol. 2014 Dec;70(12):1133-57. doi: 10.1002/jclp.22081. Epub 2014 Mar 20.
Results Reference
background
PubMed Identifier
23537485
Citation
Morrison AS, Heimberg RG. Social anxiety and social anxiety disorder. Annu Rev Clin Psychol. 2013;9:249-74. doi: 10.1146/annurev-clinpsy-050212-185631.
Results Reference
background
PubMed Identifier
23223206
Citation
Richey JA, Rittenberg A, Hughes L, Damiano CR, Sabatino A, Miller S, Hanna E, Bodfish JW, Dichter GS. Common and distinct neural features of social and non-social reward processing in autism and social anxiety disorder. Soc Cogn Affect Neurosci. 2014 Mar;9(3):367-77. doi: 10.1093/scan/nss146. Epub 2012 Dec 7.
Results Reference
background
PubMed Identifier
19174537
Citation
Spreckelmeyer KN, Krach S, Kohls G, Rademacher L, Irmak A, Konrad K, Kircher T, Grunder G. Anticipation of monetary and social reward differently activates mesolimbic brain structures in men and women. Soc Cogn Affect Neurosci. 2009 Jun;4(2):158-65. doi: 10.1093/scan/nsn051. Epub 2009 Jan 27.
Results Reference
background
PubMed Identifier
24188418
Citation
Van Bockstaele B, Verschuere B, Tibboel H, De Houwer J, Crombez G, Koster EH. A review of current evidence for the causal impact of attentional bias on fear and anxiety. Psychol Bull. 2014 May;140(3):682-721. doi: 10.1037/a0034834. Epub 2013 Nov 4.
Results Reference
background

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A Novel Computer-Based Therapy for Social Anxiety

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