Computer-Based Treatment for Social Anxiety Disorder

NCT03415022 | Completed Results

• 1 other identifier: #7598
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Social Anxiety Disorder

Keywords

SAD; Social Anxiety; Social Phobia

Outcome Measures

Primary Outcomes (2)

• Change in Percent Dwell Time on Threat Faces

  Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline.

  baseline to week 8

• Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)

  Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety.

  Baseline to week 8

Secondary Outcomes (6)

• Change in Total Score of Social Phobia Inventory (SPIN)

  baseline to week 8

• Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire

  baseline to week 8

• Change in Total Score of the Revised Social Anhedonia Scale

  baseline to week 8

• Change in Total Score of the Snaith Hamilton Pleasure Scale

  baseline to week 8

• Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version

  baseline to week 8

Study Arms (2)

4-week computer-based treatment

EXPERIMENTAL

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

Behavioral: computer-based treatment

8-week computer-based treatment

EXPERIMENTAL

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.

Behavioral: computer-based treatment

Interventions

computer-based treatment BEHAVIORAL

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

4-week computer-based treatment; 8-week computer-based treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

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: 27907025 BACKGROUND

• 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: 20005616 BACKGROUND

• 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: 12169250 BACKGROUND

• 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: 26080314 BACKGROUND

• 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: 22425719 BACKGROUND

• 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: 23547713 BACKGROUND

• 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: 26774515 BACKGROUND

• 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: 28103714 BACKGROUND

• 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: 25708991 BACKGROUND

• 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: 24652823 BACKGROUND

• 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: 23537485 BACKGROUND

• 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: 23223206 BACKGROUND

• 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: 19174537 BACKGROUND

• 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: 24188418 BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Franklin Schneier
• Organization: New York State Psychiatric Institue

Franklin.Schneier@nyspi.columbia.edu

646-774-8041

Study Officials

• Franklin Schneier, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not be informed as to whether a participant is randomized to 4 or 8 weeks of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: Computer-based task involving free viewing of faces and listening to music

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 30, 2018
• Study Start: January 30, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 4, 2022
• Results First Posted: August 11, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Raw data will be submitted semi-annually every January 15 and July 15.
• Access Criteria: see URL below for criteria

Locations

US (1)