A Novel Computer-Based Therapy for Social Anxiety

NCT ID: NCT03240003

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-25

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GC-MRT

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

Group Type EXPERIMENTAL

GC-MRT

Intervention Type BEHAVIORAL

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

non-GC-MRT

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

Group Type ACTIVE_COMPARATOR

Non-GC-MRT

Intervention Type BEHAVIORAL

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

GC-MRT-modified

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

Group Type EXPERIMENTAL

modified GC-MRT

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GC-MRT

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

Intervention Type BEHAVIORAL

modified GC-MRT

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

Intervention Type BEHAVIORAL

Non-GC-MRT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Franklin Schneier

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Franklin Schneier, MD

Role: PRINCIPAL_INVESTIGATOR

NYSPI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27907025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20005616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12169250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26080314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22425719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23547713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26774515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28103714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25708991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24652823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23537485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23223206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19174537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24188418 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7527 (SAD)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Novel Anxiety Treatment
NCT03790696 COMPLETED NA
VR Mind and VR Mind+ Intervention
NCT03895957 COMPLETED NA