A Novel Computer-Based Therapy for Social Anxiety

Social Anxiety Disorder Clinical Trial

Official title:

A Novel Computer-Based Therapy for Social Anxiety

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03240003
• Other study ID #: 7527 (SAD)
• Status: Suspended
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• GC-MRT
Group 1 will receive a 4-week (8-sessions) course of GC-MRT
• modified GC-MRT
group 3 will receive a 4-week (8-sessions) course of GC-MRT, modified
• Non-GC-MRT
Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale	Total score of the Liebowitz Social Anxiety Scale	4 months
Secondary	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).	4 months
Secondary	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.	4 months
Secondary	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).	4 months
Secondary	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)	4 months
Secondary	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).	4 months
Secondary	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.	4 months