NCT03240003

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)

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2017Dec 2026

First Submitted

Initial submission to the registry

July 25, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

August 25, 2017

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

9.3 years

First QC Date

July 25, 2017

Last Update Submit

February 2, 2026

Conditions

Social Anxiety Disorder

Keywords

Social AnxietySocial Anxiety DisorderSAD

Outcome Measures

Primary Outcomes (1)

  • Liebowitz Social Anxiety Scale

    Total score of the Liebowitz Social Anxiety Scale

    4 months

Secondary Outcomes (6)

  • Social Phobia Inventory (SPIN)

    4 months

  • Quality of Life Enjoyment & Satisfaction Questionnaire

    4 months

  • Revised Social Anhedonia Scale

    4 months

  • Snaith Hamilton Pleasure Scale

    4 months

  • Hamilton Rating Scale for Depression - 17 item version

    4 months

  • +1 more secondary outcomes

Study Arms (3)

GC-MRT

EXPERIMENTAL

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

Behavioral: GC-MRT

non-GC-MRT

ACTIVE COMPARATOR

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

Behavioral: Non-GC-MRT

GC-MRT-modified

EXPERIMENTAL

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

Behavioral: modified GC-MRT

Interventions

GC-MRTBEHAVIORAL

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

GC-MRT
modified GC-MRTBEHAVIORAL

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

GC-MRT-modified
Non-GC-MRTBEHAVIORAL

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

non-GC-MRT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (14)

  • 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.

    PMID: 27907025BACKGROUND

  • 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.

    PMID: 20005616BACKGROUND

  • 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.

    PMID: 12169250BACKGROUND

  • 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.

    PMID: 26080314BACKGROUND

  • 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.

    PMID: 22425719BACKGROUND

  • 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.

    PMID: 23547713BACKGROUND

  • 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.

    PMID: 26774515BACKGROUND

  • 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.

    PMID: 28103714BACKGROUND

  • 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.

    PMID: 25708991BACKGROUND

  • 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.

    PMID: 24652823BACKGROUND

  • 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.

    PMID: 23537485BACKGROUND

  • 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.

    PMID: 23223206BACKGROUND

  • 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.

    PMID: 19174537BACKGROUND

  • 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.

    PMID: 24188418BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Franklin Schneier, MD

    NYSPI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 4, 2017

Study Start

August 25, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)