Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05305235
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2022-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
RCT for Innovating Stress-related eHealth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nicole.short@unlv.edu', 'phone': '702-895-3305', 'title': 'Nicole Short, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signing informed consent through 6-month follow-up, up to 7 months total.', 'eventGroups': [{'id': 'EG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Adherence/Acceptability Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'OG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.53', 'spread': '7.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Week', 'description': 'The Treatment Adherence/Acceptability Scale (TAAS) is a 10-item measure of treatment acceptability (e.g., I would recommend this treatment to a friend) and adherence (e.g., I would be able to finish \\[this treatment\\]) that participants rate on a 7-point Likert scale with scores ranging from 10-70. Higher scores indicate higher acceptability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was only provided to participants in the active (RISE Guide) condition. Data are reported for all RISE Guide participants who opted to complete the TAAS.'}, {'type': 'SECONDARY', 'title': 'Credibility/Expectancy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'OG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.85', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '18.61', 'spread': '13.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 Week', 'description': 'Credibility/Expectancy Questionnaire (CEQ; 1 week) 6-item measure of treatment credibility and expectancy of treatment to improve symptoms. Items are rated on 9-to-11-point Likert scales. 11-point scales (0-100% in 10% intervals are recoded to align with the 1-9 scales). Higher scores indicate higher credibility/expectancy. Scores can range from 4 to 56.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All data collected are reported, some were missing due to attrition. Some participants chose to opt out of certain questionnaires.'}, {'type': 'SECONDARY', 'title': 'Treatment Utilization and Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'OG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.45', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '6.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 Week', 'description': '6 items self-report survey created for the current study on a 5-point Likert scale, such as How often did you log in? How interested were you? and 4 open-ended questions; e.g., What did you like about RISE Guide?; What did you not like? Lower scores indicate higher treatment utilization and acceptability. Scores range from 6-30.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All data collected are reported, some were missing due to attrition. Some participants chose to opt out of certain questionnaires.'}, {'type': 'SECONDARY', 'title': 'Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants Enrolled and Randomized', 'description': 'Participants who were enrolled and randomized regardless of treatment condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '2.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first to last participant approached (up to 20 months)', 'description': 'The purpose of this outcome is to measure feasibility across the entirety of successful recruitment and randomization.', 'unitOfMeasure': 'Participants recruited and randomized', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Final Proportion of Participants Who Completed Follow-ups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'OG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}], 'classes': [{'title': '7 Weeks', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000'}, {'value': '0.67', 'groupId': 'OG001'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '0.70', 'groupId': 'OG000'}, {'value': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)', 'description': 'The proportion of participants who complete follow-ups (i.e., 7-week, 6 months) will be used to evaluate feasibility of retaining the target sample (goal retention=75% or higher).', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Unexpected Adverse Events by Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'OG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to approximately 7 months', 'description': "Investigators will examine whether unexpected adverse events occur throughout each participant's participation in the study.", 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on Cognitive Anxiety Sensitivity Treatment (CAST), an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'FG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'preAssignmentDetails': 'Of the 75 participants who signed informed consent, only 60 completed the required one-week follow up and were randomly assigned to a treatment intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on CAST, an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.\n\nRISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.'}, {'id': 'BG001', 'title': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.\n\nRelaxation Control: Guides users through relaxation techniques.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.80', 'spread': '6.90', 'groupId': 'BG000'}, {'value': '25.38', 'spread': '6.64', 'groupId': 'BG001'}, {'value': '25.56', 'spread': '6.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-27', 'size': 1617418, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-12T15:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not be masked to their study conditions, as branding is visible in both RISE Guide and Breathe2Relax. Moreover, the UNC Research Coordinators will not be masked to condition, as they will be responsible for tracking RISE Guide progress and managing participant payments. The Principal Investigator, Biostatistician, Site Principal Investigators, Site Research Associates, and anyone involved in data analysis will remain masked to condition until data analysis is complete; masking will be maintained through reduced data viewing privileges in REDCap.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization tables will be generated by the study Biostatistician and uploaded into the study REDCap database by a UNC Research Coordinator prior to launching data collection. Participants are randomized (1:1) to receive either the RISE Guide (experimental) condition or Breathe2Relax (control) condition after completing their 1-week survey. The list of assignments will be stored securely in REDCap.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2022-03-22', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-27', 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Adherence/Acceptability Scale', 'timeFrame': '1 Week', 'description': 'The Treatment Adherence/Acceptability Scale (TAAS) is a 10-item measure of treatment acceptability (e.g., I would recommend this treatment to a friend) and adherence (e.g., I would be able to finish \\[this treatment\\]) that participants rate on a 7-point Likert scale with scores ranging from 10-70. Higher scores indicate higher acceptability.'}], 'secondaryOutcomes': [{'measure': 'Credibility/Expectancy Questionnaire', 'timeFrame': '7 Week', 'description': 'Credibility/Expectancy Questionnaire (CEQ; 1 week) 6-item measure of treatment credibility and expectancy of treatment to improve symptoms. Items are rated on 9-to-11-point Likert scales. 11-point scales (0-100% in 10% intervals are recoded to align with the 1-9 scales). Higher scores indicate higher credibility/expectancy. Scores can range from 4 to 56.'}, {'measure': 'Treatment Utilization and Acceptability', 'timeFrame': '7 Week', 'description': '6 items self-report survey created for the current study on a 5-point Likert scale, such as How often did you log in? How interested were you? and 4 open-ended questions; e.g., What did you like about RISE Guide?; What did you not like? Lower scores indicate higher treatment utilization and acceptability. Scores range from 6-30.'}, {'measure': 'Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study', 'timeFrame': 'From first to last participant approached (up to 20 months)', 'description': 'The purpose of this outcome is to measure feasibility across the entirety of successful recruitment and randomization.'}, {'measure': 'Final Proportion of Participants Who Completed Follow-ups', 'timeFrame': '7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)', 'description': 'The proportion of participants who complete follow-ups (i.e., 7-week, 6 months) will be used to evaluate feasibility of retaining the target sample (goal retention=75% or higher).'}, {'measure': 'Unexpected Adverse Events by Event', 'timeFrame': 'up to approximately 7 months', 'description': "Investigators will examine whether unexpected adverse events occur throughout each participant's participation in the study."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Clinical Trials, Randomized', 'Prevention', 'eHealth', 'Anxiety Sensitivity'], 'conditions': ['Posttraumatic Stress Disorder', 'Sexual Assault', 'Pain']}, 'referencesModule': {'references': [{'pmid': '25848562', 'type': 'BACKGROUND', 'citation': 'Broderick JE, DeWitt EM, Rothrock N, Crane PK, Forrest CB. Advances in Patient-Reported Outcomes: The NIH PROMIS((R)) Measures. EGEMS (Wash DC). 2013 Aug 2;1(1):1015. doi: 10.13063/2327-9214.1015. eCollection 2013.'}, {'pmid': '41379700', 'type': 'DERIVED', 'citation': 'Short NA, Pezza M, Reyes LD, Black J, Serrano K, McLean SA. The role of posttraumatic stress disorder symptoms in pain severity, interference, and variability after sexual assault: An ecological momentary assessment study. J Psychopathol Clin Sci. 2025 Dec 11. doi: 10.1037/abn0001083. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "The Randomized Control Trial for Innovating Stress-related eHealth (RISE) Study tests the hypotheses that a highly promising digital therapeutic (RISE Guide) targeting anxiety sensitivity (AS) will be acceptable to women sexual assault survivors; reduce survivors' anxiety sensitivity, and, in turn, posttraumatic stress.\n\nIf successful, RISE Guide could be provided at no cost to all women who present to US emergency departments for emergency care after sexual assault.", 'detailedDescription': 'The RISE Study plans to recruit up to 60 women (natal and self-identifying) who present for Sexual Assault Nurse Examiner (SANE) care within 72 hours of experiencing sexual assault. Willing participants will complete enrollment procedures (i.e., consent forms and initial survey) during this same, initial SANE care visit.\n\nAll enrolled participants will complete 4/day ecological momentary assessments (EMAs; day 1 through day 49) and complete a follow-up assessment at week 1. More information on EMA and week 1 assessment content is available in the "Outcome Measurements" section of this listing.\n\nFollowing their week 1 survey, all participants will be randomized into either the active (RISE Guide) or control (Breathe2Relax app) condition. Participants will receive a link to their assigned intervention. Participants in the active condition will additionally begin receiving ecological momentary interventions (EMIs) at the end of their ecological momentary assessments, which consist of personalized feedback based on symptoms reported during EMAs.\n\nAll participants will receive an Empatica wristband in the mail. Participants will wear the wristband week 1 through week 7 and press a button on the wristband\'s interface whenever they experience internal (e.g. thought) or external (e.g. seeing the assailant in public) trauma reminders. The wristband will collect continuous data on participants\' heart rate, temperature, and perspiration, which will be used as measurements of stress reactivity.\n\nAll participants will complete further follow-up assessments at week 7, month 6, and month 12.\\* More information on each follow-up assessment\'s content is available in the "Outcome Measurements" section of this listing.\n\n\\*The month 12 follow-up assessment was removed via an IRB modification approved on December 14, 2022. Participants enrolled after December 14, 2022 will not complete this timepoint.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Identifies as woman.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women sexual assault survivors presenting for emergency care \\<72 hours post-assault at one of our study locations.\n* English speakers\n* 18+ years of age\n* Able to provide informed consent\n* Have a smartphone with continuous service \\>1 year\n\nExclusion Criteria:\n\n* Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening).\n* Prisoner\n* Currently pregnant\n* Lives with assailant and plans to continue to do so\n* Admitted patient\n* No mailing address\n* Previously enrolled\n* No SANE examination'}, 'identificationModule': {'nctId': 'NCT05305235', 'acronym': 'RISE', 'briefTitle': 'RCT for Innovating Stress-related eHealth', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault', 'orgStudyIdInfo': {'id': '20-3494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RISE Guide', 'description': 'The RISE (RCT for Innovating Stress-related eHealth) Guide is based on Cognitive Anxiety Sensitivity Treatment (CAST), an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs)\n\nRISE Guide delivered by smartphone via Qualtrics and is completed in \\~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.', 'interventionNames': ['Device: RISE Guide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation Control', 'description': 'Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.', 'interventionNames': ['Device: Relaxation Control']}], 'interventions': [{'name': 'RISE Guide', 'type': 'DEVICE', 'otherNames': ['RCT for Innovating Stress-related eHealth'], 'description': 'Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.', 'armGroupLabels': ['RISE Guide']}, {'name': 'Relaxation Control', 'type': 'DEVICE', 'otherNames': ['Breathe2Relax'], 'description': 'Guides users through relaxation techniques.', 'armGroupLabels': ['Relaxation Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill, SANE Program', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '78760', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Stop Abuse for Everyone (SAFE)', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Samuel A. McLean, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Nicole A. Short, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nevada, Las Vegas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available 9 to 36 months following publication and will remain available for five years.', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared by reasonable request beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'The investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayday Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}