Computer-Based Treatment for Social Anxiety Disorder

NCT ID: NCT03415022

Last Updated: 2022-04-04

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2020-03-31

Brief Summary

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The present study is an open trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)

Detailed Description

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This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed computer-based therapy 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, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).

Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Computer-based task involving free viewing of faces and listening to music
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor will not be informed as to whether a participant is randomized to 4 or 8 weeks of treatment.

Study Groups

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4-week computer-based treatment

A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.

Group Type EXPERIMENTAL

computer-based treatment

Intervention Type BEHAVIORAL

30 minute sessions of free viewing of faces and listening to music

8-week computer-based treatment

An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.

Group Type EXPERIMENTAL

computer-based treatment

Intervention Type BEHAVIORAL

30 minute sessions of free viewing of faces and listening to music

Interventions

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computer-based treatment

30 minute sessions of free viewing of faces and listening to music

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males and females between the ages of 18 and 60
* Current 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 posttraumatic stress disorder, 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
* 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

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Franklin Schneier

Research Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franklin Schneier, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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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)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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#7598

Identifier Type: -

Identifier Source: org_study_id

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