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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)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computer-based treatment | Behavioral | 30 minute sessions of free viewing of faces and listening to music |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score of Social Phobia Inventory (SPIN) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franklin Schneier, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27907025 | Background | 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. | |
| 20005616 | 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. |
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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.
Raw data will be submitted semi-annually every January 15 and July 15.
see URL below for criteria
9 participants discontinued the study after initial evaluation but before treatment randomization:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who started treatment sessions
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. computer-based treatment: 30 minute sessions of free viewing of faces and listening to music |
| BG001 | 8-week Computer-based Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of dwell time on threat faces | baseline to week 8 |
|
20 weeks (8 weeks of active treatment phase and 3 month follow-up phase)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Computer-based treatment: 30 minute sessions of free viewing of faces and listening to music |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Franklin Schneier | New York State Psychiatric Institue | 646-774-8041 | Franklin.Schneier@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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Computer-based task involving free viewing of faces and listening to music
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Outcomes assessor will not be informed as to whether a participant is randomized to 4 or 8 weeks of treatment.
| Change in Total Score of 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. | baseline to week 8 |
| Change in Total Score of the 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) | baseline to week 8 |
| Change in Total Score of the Snaith Hamilton Pleasure Scale | 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 | 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 | 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 |
| 12169250 | 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. |
| 26080314 | 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. |
| 22425719 | 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. |
| 23547713 | 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. |
| 26774515 | 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. |
| 28103714 | 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. |
| 25708991 | 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. |
| 24652823 | 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. |
| 23537485 | 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. |
| 23223206 | 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. |
| 19174537 | 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. |
| 24188418 | 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. |
| Lost to Follow-up |
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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. computer-based treatment: 30 minute sessions of free viewing of faces and listening to music |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Liebowitz Social Anxiety Scale | This clinician-reported scale is used to assess social anxiety. Participants were provided with a list of 24 social situations and rated their anxiety in that situation on a scale from 0-3, and their avoidance of that situation on a scale from 0-3. The measure is scored by adding the total of anxiety ratings and avoidance ratings (scores range from 0-144). | Mean | Standard Deviation | units on a scale |
|
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.
|
|
| Primary | 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. | Participants who completed 8 weeks of study participation | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 8 |
|
|
|
| Secondary | Change in Total Score of Social Phobia Inventory (SPIN) | 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). | participants with 8 weeks of assessments | Posted | Mean | Standard Deviation | score on a scale | baseline to week 8 |
|
|
|
| Secondary | Change in Total Score of 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. | participants who completed 8 weeks of assessments | Posted | Mean | Standard Deviation | score on a scale | baseline to week 8 |
|
|
|
| Secondary | Change in Total Score of the 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) | participants who completed 8 weeks of assessments | Posted | Mean | Standard Deviation | units on a scale | baseline to week 8 |
|
|
|
| Secondary | Change in Total Score of the Snaith Hamilton Pleasure Scale | 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) | participants who completed 8 weeks of assessments | Posted | Mean | Standard Deviation | units on a scale | baseline to week 8 |
|
|
|
| Secondary | Change in Total Score of the 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). | participants who completed 8 weeks of assessments | Posted | Mean | Standard Deviation | units on a scale | baseline to week 8 |
|
|
|
| Secondary | Clinical Global Impression-Change Scale | 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. | participants who completed 8 weeks of assessments | Posted | Mean | Standard Deviation | units on a scale | week 8 |
|
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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