- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415022
Computer-Based Treatment for Social Anxiety Disorder
March 31, 2022 updated by: Franklin Schneier, New York State Psychiatric Institute
A Novel Computer-Based Treatment for Social Anxiety: Target Engagement
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
30 minute sessions of free viewing of faces and listening to music
|
Experimental: 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.
|
30 minute sessions of free viewing of faces and listening to music
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Percent Dwell Time on Threat Faces
Time Frame: baseline to week 8
|
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)
Time Frame: Baseline to week 8
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Score of Social Phobia Inventory (SPIN)
Time Frame: baseline to week 8
|
The Social Phobia Inventory (SPIN) is a self-rated questionnaire 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).
|
baseline to week 8
|
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
Time Frame: baseline to week 8
|
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.
|
baseline to week 8
|
Change in Total Score of the Revised Social Anhedonia Scale
Time Frame: baseline to week 8
|
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)
|
baseline to week 8
|
Change in Total Score of the Snaith Hamilton Pleasure Scale
Time Frame: baseline to week 8
|
Snaith Hamilton Pleasure Scale (SHAPS).
Fourteen-item self-rated anhedonia scale.
Items are comprised of statements that participants rate 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)
|
baseline to week 8
|
Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version
Time Frame: baseline to week 8
|
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).
|
baseline to week 8
|
Clinical Global Impression-Change Scale
Time Frame: week 8
|
Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse).
Responder category is defined by a score of 1 or 2.
|
week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
January 29, 2018
First Posted (Actual)
January 30, 2018
Study Record Updates
Last Update Posted (Actual)
April 4, 2022
Last Update Submitted That Met QC Criteria
March 31, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #7598
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be shared through the National Database for Clinical Trials related to Mental Illness (NDCT).
We will generate a Global Unique Identifier (GUID) for each participant.
The key clinical rating scale measures (LSAS, SPIN, QLESQ, HRSD) are all included.
IPD Sharing Time Frame
Raw data will be submitted semi-annually every January 15 and July 15.
IPD Sharing Access Criteria
see URL below for criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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