Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-31 @ 8:24 AM
Study NCT ID:
NCT04729803
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Attention, Teleconferencing and Social Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mrubin@paloaltou.edu', 'phone': '650-433-3805', 'title': 'Dr. Mikael Rubin', 'organization': 'palo alto university'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'four weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Personal Report of Communication Apprehension Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'OG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'OG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.06', 'spread': '11.66', 'groupId': 'OG000'}, {'value': '87.64', 'spread': '11.91', 'groupId': 'OG001'}, {'value': '95.69', 'spread': '14.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to the first treatment session, an average of 2 days', 'description': 'Assessment of communication concerns, range of scores is 24-120; higher scores are worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Personal Report of Communication Apprehension Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'OG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'OG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.71', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '65.90', 'spread': '5.36', 'groupId': 'OG001'}, {'value': '70.00', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-week follow-up', 'description': 'Assessment of communication concerns, range of scores is 24-120; higher scores are worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Personal Report of Communication Apprehension Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'OG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'OG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.25', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '67.13', 'spread': '3.23', 'groupId': 'OG001'}, {'value': '71.00', 'spread': '1.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week follow-up', 'description': 'Assessment of communication concerns, range of scores is 24-120; higher scores are worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leibowitz Social Anxiety Scale Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'OG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'OG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.06', 'spread': '13.40', 'groupId': 'OG000'}, {'value': '74.50', 'spread': '13.94', 'groupId': 'OG001'}, {'value': '87.77', 'spread': '19.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to the first treatment session, an average of 2 days', 'description': 'Assessment of general social anxiety, range of scores is 0-144; higher scores are worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leibowitz Social Anxiety Scale Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'OG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'OG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.99', 'spread': '23.60', 'groupId': 'OG000'}, {'value': '57.70', 'spread': '19.24', 'groupId': 'OG001'}, {'value': '71.00', 'spread': '26.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1-week follow-up', 'description': 'Assessment of general social anxiety, range of scores is 0-144; higher scores are worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leibowitz Social Anxiety Scale Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'OG001', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'OG002', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.67', 'spread': '23.52', 'groupId': 'OG000'}, {'value': '50.13', 'spread': '15.72', 'groupId': 'OG001'}, {'value': '71.00', 'spread': '30.91', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-week follow-up', 'description': 'Assessment of general social anxiety, range of scores is 0-144; higher scores are worse', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}, {'id': 'FG001', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'FG002', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Post-treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.\n\nExperimental: Attention Guidance + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.'}, {'id': 'BG001', 'title': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.\n\nActive Comparator: Exposure Alone: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n2\\) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.'}, {'id': 'BG002', 'title': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.\n\nExperimental: Attention Control + Exposure: 1) Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\nF 2) Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n\n3\\) Between speeches participants will have a 1-minute break. 4) Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.20', 'spread': '1.52', 'groupId': 'BG000'}, {'value': '18.70', 'spread': '1.02', 'groupId': 'BG001'}, {'value': '19.5', 'spread': '1.77', 'groupId': 'BG002'}, {'value': '19.13', 'spread': '1.44', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-02', 'size': 564587, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-05T03:23', 'hasProtocol': True}, {'date': '2022-12-05', 'size': 156152, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-05T19:55', 'hasProtocol': False}, {'date': '2020-12-02', 'size': 515566, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-05T03:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2020-12-07', 'resultsFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-05', 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Personal Report of Communication Apprehension Questionnaire', 'timeFrame': 'prior to the first treatment session, an average of 2 days', 'description': 'Assessment of communication concerns, range of scores is 24-120; higher scores are worse'}, {'measure': 'Personal Report of Communication Apprehension Questionnaire', 'timeFrame': '1-week follow-up', 'description': 'Assessment of communication concerns, range of scores is 24-120; higher scores are worse'}, {'measure': 'Personal Report of Communication Apprehension Questionnaire', 'timeFrame': '2-week follow-up', 'description': 'Assessment of communication concerns, range of scores is 24-120; higher scores are worse'}, {'measure': 'Leibowitz Social Anxiety Scale Questionnaire', 'timeFrame': 'prior to the first treatment session, an average of 2 days', 'description': 'Assessment of general social anxiety, range of scores is 0-144; higher scores are worse'}, {'measure': 'Leibowitz Social Anxiety Scale Questionnaire', 'timeFrame': '1-week follow-up', 'description': 'Assessment of general social anxiety, range of scores is 0-144; higher scores are worse'}, {'measure': 'Leibowitz Social Anxiety Scale Questionnaire', 'timeFrame': '2-week follow-up', 'description': 'Assessment of general social anxiety, range of scores is 0-144; higher scores are worse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Social Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'This study involves completing some online assessments and an intervention for social anxiety that all involve interactions with other people on a teleconferencing call.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75\n* Fluent in English because the data collection materials have not yet been standardized in other languages\n* Having access to a computer with a webcam and ability to record audio\n* Personal Report of Communication Apprehension \\> 80\n* Leibowitz Social Anxiety Scale \\> 30\n* Meets DSM-5 Criteria for Social Anxiety Disorder\n\nExclusion Criteria:\n\n* Significant visual impairment precluding the use of the eye tracking equipment\n* Current, or history of bipolar disorder; current, or history of psychosis'}, 'identificationModule': {'nctId': 'NCT04729803', 'briefTitle': 'Attention, Teleconferencing and Social Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Investigating Attentional Processes: Teleconferencing and Social Anxiety', 'orgStudyIdInfo': {'id': 'STUDY00000106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention Guidance + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention guidance component.', 'interventionNames': ['Behavioral: Experimental: Attention Guidance + Exposure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exposure Alone', 'description': 'Participants will complete teleconferencing-based exposure trials.', 'interventionNames': ['Behavioral: Active Comparator: Exposure Alone']}, {'type': 'EXPERIMENTAL', 'label': 'Attention Control + Exposure', 'description': 'Participants will complete teleconferencing-based exposure trials with an attention control component.', 'interventionNames': ['Behavioral: Experimental: Attention Control + Exposure']}], 'interventions': [{'name': 'Experimental: Attention Guidance + Exposure', 'type': 'BEHAVIORAL', 'description': '1. Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n2. Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n3. Between speeches participants will have a 1-minute break.\n4. Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response.', 'armGroupLabels': ['Attention Guidance + Exposure']}, {'name': 'Active Comparator: Exposure Alone', 'type': 'BEHAVIORAL', 'description': '1. Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n2. Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.\n3. Between speeches participants will have a 1-minute break.\n4. Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.', 'armGroupLabels': ['Exposure Alone']}, {'name': 'Experimental: Attention Control + Exposure', 'type': 'BEHAVIORAL', 'description': '1. Participants will receive a brief standardized psychoeducation module, presented via a video recording.\n\n F\n2. Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.\n3. Between speeches participants will have a 1-minute break.\n4. Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.\n\nThe experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response.', 'armGroupLabels': ['Attention Control + Exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Laboratory for the Study of Anxiety Disorders, University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Anonymized data and analysis syntax will be made available using an open data repository (e.g. osf.io)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}