Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 12:49 AM
Study NCT ID:
NCT04986904
Status:
COMPLETED
Last Update Posted:
2024-10-23
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kshaffer@virginia.edu', 'phone': '434-982-1022', 'title': 'Dr. Kelly Shaffer', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'SHUTi (Sleep Healthy Using the Internet)', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SHUTi Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SHUTi (Sleep Healthy Using the Internet)', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program'}], 'classes': [{'categories': [{'title': 'Non-User', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Incomplete User', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Complete User', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9-week Post-assessment', 'description': 'Level of SHUTi engagement: Core completion (i.e., nonuser \\[no cores completed\\], incomplete user \\[1-3 Cores\\], or complete user \\[4-6 Cores\\])', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep-related Cognitions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SHUTi Non-Users', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.\n\nParticipants were classified as non-users if they did not complete any of the six SHUTi Cores.'}, {'id': 'OG001', 'title': 'SHUTi Incomplete Users', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.\n\nParticipants were classified as users if they completed one to three of the six SHUTi Cores.'}, {'id': 'OG002', 'title': 'SHUTi Complete Users', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.\n\nParticipants were classified as users if they completed four or more of the six SHUTi Cores.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.61', 'spread': '31.54', 'groupId': 'OG000'}, {'value': '92.68', 'spread': '18.20', 'groupId': 'OG001'}, {'value': '86.08', 'spread': '27.04', 'groupId': 'OG002'}]}]}, {'title': 'Post-Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.12', 'spread': '36.20', 'groupId': 'OG001'}, {'value': '54.82', 'spread': '30.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment.'}, {'type': 'SECONDARY', 'title': 'Sleep Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SHUTi Non-Users', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.\n\nParticipants were classified as non-users if they did not complete any of the six SHUTi Cores.'}, {'id': 'OG001', 'title': 'SHUTi Incomplete Users', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.\n\nParticipants were classified as users if they completed one to three of the six SHUTi Cores.'}, {'id': 'OG002', 'title': 'SHUTi Complete Users', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program.\n\nParticipants were classified as users if they completed four or more of the six SHUTi Cores.'}], 'classes': [{'title': 'Baseline Sleep Locus of Control - Internal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.06', 'spread': '4.49', 'groupId': 'OG000'}, {'value': '14.77', 'spread': '4.06', 'groupId': 'OG001'}, {'value': '15.02', 'spread': '4.85', 'groupId': 'OG002'}]}]}, {'title': 'Post-Assessment Sleep Locus of Control - Internal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.94', 'spread': '6.39', 'groupId': 'OG001'}, {'value': '16.93', 'spread': '5.12', 'groupId': 'OG002'}]}]}, {'title': 'Baseline Sleep Locus of Control - External', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.11', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '8.14', 'spread': '3.17', 'groupId': 'OG001'}, {'value': '8.68', 'spread': '3.72', 'groupId': 'OG002'}]}]}, {'title': 'Post-Assessment Sleep Locus of Control - External', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.69', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '6.75', 'spread': '3.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Sleep Locus of Control Scale with two subscales:\n\n1. a 5-item subscale for internal locus of control; summed scores per scale range from 5 to 30 (higher scores indicate higher belief in the locus of control measured; higher internal sleep locus of control is a better outcome)\n2. a 3-item subscale for external locus of control; summed scores per scale range from 3 to 18 (higher scores indicate higher belief in the locus of control measured; lower external sleep locus of control is a better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SHUTi Non-Users did not complete this measure at post-assessment. There were 6 SHUTi Incomplete Users who did not complete the post-assessment. All SHUTi Complete Users completed post-assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Open-ended Feedback on SHUTi', 'timeFrame': '9-week Post-assessment', 'description': "Non-users' post-assessment will include an open-ended survey regarding barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. Users' (i.e., incomplete and complete) post-assessment will include an open-ended survey assessing SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'SHUTi Evaluation', 'timeFrame': '9-week Post-assessment', 'description': "Items from the Internet Intervention Utility, Evaluation, and Adherence questionnaire assess users' perceived usability, acceptability, and perceived efficacy of SHUTi as well as barriers to program use", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caregiving Strain', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Insomnia Symptom Severity', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep Onset Latency (SOL)', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Wake After Sleep Onset (WASO)', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Data collected from sleep diary: Total time awake between time feel asleep and final morning waking', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Sleep Quality', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SHUTi (Sleep Healthy Using the Internet)', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'This is the number of participants who were enrolled in the trial.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'Completed Baseline Assessment', 'comment': 'This is the number of participants who completed the baseline assessment, and were therefore provided access to the SHUTi intervention.', 'achievements': [{'comment': 'One participant was lost-to-followup and did not complete the baseline assessment.', 'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'Completed the 9-week Intervention Period', 'comment': 'This is the number of participants who had access to SHUTi for the full 9-week intervention period, and were therefore counted towards the primary endpoint (i.e., level of engagement).', 'achievements': [{'comment': 'One participant withdrew during the intervention period.', 'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'comment': 'This is the number of participants who completed post-assessment.', 'achievements': [{'comment': 'Ten participants were lost-to-followup and did not complete post-assessment.', 'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SHUTi (Sleep Healthy Using the Internet)', 'description': 'Participants were assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They spent 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progressed through the intervention, they received automated, tailored instructions for how to improve their sleep.\n\nSHUTi (Sleep Healthy Using the Internet): Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.82', 'spread': '13.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Results are only reported from the 100 participants who received access to the SHUTi intervention for the full intervention period, and are therefore counted towards the primary endpoint (i.e., level of engagement). One participant who completed baseline but withdrew during the intervention period is excluded.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-16', 'size': 978385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-06T14:57', 'hasProtocol': True}, {'date': '2022-08-16', 'size': 493825, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-10T16:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2021-07-16', 'resultsFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-30', 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Open-ended Feedback on SHUTi', 'timeFrame': '9-week Post-assessment', 'description': "Non-users' post-assessment will include an open-ended survey regarding barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. Users' (i.e., incomplete and complete) post-assessment will include an open-ended survey assessing SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers."}, {'measure': 'SHUTi Evaluation', 'timeFrame': '9-week Post-assessment', 'description': "Items from the Internet Intervention Utility, Evaluation, and Adherence questionnaire assess users' perceived usability, acceptability, and perceived efficacy of SHUTi as well as barriers to program use"}, {'measure': 'Caregiving Strain', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)'}, {'measure': 'Insomnia Symptom Severity', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Insomnia severity index; 2 items; summed scores range from 0 to 8 (higher scores indicate more severe insomnia symptoms)'}, {'measure': 'Sleep Onset Latency (SOL)', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep'}, {'measure': 'Wake After Sleep Onset (WASO)', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Data collected from sleep diary: Total time awake between time feel asleep and final morning waking'}, {'measure': 'Perceived Sleep Quality', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good'}], 'primaryOutcomes': [{'measure': 'SHUTi Engagement', 'timeFrame': '9-week Post-assessment', 'description': 'Level of SHUTi engagement: Core completion (i.e., nonuser \\[no cores completed\\], incomplete user \\[1-3 Cores\\], or complete user \\[4-6 Cores\\])'}], 'secondaryOutcomes': [{'measure': 'Sleep-related Cognitions', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)'}, {'measure': 'Sleep Self-efficacy', 'timeFrame': 'Baseline Pre-assessment and 9-week Post-assessment', 'description': 'Sleep Locus of Control Scale with two subscales:\n\n1. a 5-item subscale for internal locus of control; summed scores per scale range from 5 to 30 (higher scores indicate higher belief in the locus of control measured; higher internal sleep locus of control is a better outcome)\n2. a 3-item subscale for external locus of control; summed scores per scale range from 3 to 18 (higher scores indicate higher belief in the locus of control measured; lower external sleep locus of control is a better outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Family Caregivers', 'Insomnia', 'Sleep Initiation and Maintenance Disorders']}, 'referencesModule': {'references': [{'pmid': '35019846', 'type': 'BACKGROUND', 'citation': 'Shaffer KM, Ritterband LM, You W, Buysse DJ, Mattos MK, Camacho F, Glazer JV, Klinger J, Donovan H. Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Jan 12;11(1):e34792. doi: 10.2196/34792.'}, {'pmid': '38982942', 'type': 'RESULT', 'citation': "Shaffer KM, Ritterband LM, You W, Mattos MK, Buysse DJ, Glazer JV, Klinger J, Donovan H. Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):645-657. doi: 10.1093/abm/kaae031."}, {'pmid': '38990523', 'type': 'RESULT', 'citation': 'Shaffer KM, Perepezko K, Glazer JV, Mattos MK, Klinger J, Buysse DJ, Ritterband LM, Donovan H. Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):658-669. doi: 10.1093/abm/kaae041.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program. We will identify caregiving-related user- and environment characteristics that affect the use and impact of SHUTi, and other Internet interventions more broadly, for caregivers. We will recruit 100 high-intensity caregivers with insomnia to complete a baseline assessment of insomnia and caregiving context. Caregivers will then receive access to SHUTi in an open-label trial. At the end of the 9-week intervention period, caregivers will complete post-assessment and be categorized according to their level of engagement with the 6 SHUTi intervention lessons (or weekly "Cores"). We will test whether caregivers\' engagement with SHUTi (i.e., being a non-user vs. incomplete user vs. complete user) is associated with their caregiving-related user characteristics (i.e., caregiving strain, self-efficacy, and guilt) and environment characteristics (i.e., proximity to care recipient; care recipient functional, cognitive, and behavioral status; caregiving tasks). Caregivers\' barriers to and motivations for SHUTi engagement will be described from open-ended survey responses specific to participants\' level of engagement as part of post-assessment. We will identify non-users\' barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. We will also identify users\' (incomplete and complete) SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. Thematic coding will also examine how caregivers\' recommendations generalize to other evidence-based digital health interventions. Among caregivers using SHUTi, we will test whether the effects of SHUTi on cognitive mechanisms of change targeted by SHUTi (i.e., more adaptive sleep beliefs, internalized sleep locus of control) are associated with differences in caregiving-related user or environment characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-report providing high-intensity unpaid care (e.g., practical, medical, and/or emotional support) to a family member or "family-like" close individual, operationalized as a function of time spent caregiving and care task involvement.\n* Self-report expecting to continue provide high-intensity care for at least another 3 months.\n* Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.\n* Insomnia severity index score \\>= 10\n* Residing in the United States or U.S. territory\n* English literacy\n\nExclusion Criteria:\n\n* Unusual average bed/wake times, including for shift work\n* Current behavioral/psych treatment for insomnia\n* Medical contraindication (Restless Leg Syndrome/Periodic Limb Movement Disorder, Obstructive Sleep Apnea, narcolepsy, parasomnia, dementia, Parkinson\'s, Huntington\'s, stroke, traumatic brain injury, brain infection/tumor, pregnancy/breastfeeding, hyperthyroidism, cancer, severe respiratory disease, epilepsy)\n* Psychiatric contraindications (mania/hypomania, alcohol or substance abuse/dependence)\n* Changes to prescription medications in the past 3 months (sleep, steroid, amphetamine, other wake-promoting)\n* Severe computer literacy challenges'}, 'identificationModule': {'nctId': 'NCT04986904', 'briefTitle': 'Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers: A Mixed Methods Approach', 'orgStudyIdInfo': {'id': 'HSR210255'}, 'secondaryIdInfos': [{'id': 'R21TR003522', 'link': 'https://reporter.nih.gov/quickSearch/R21TR003522', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHUTi (Sleep Healthy Using the Internet)', 'description': 'Participants will be assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They will spend 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the intervention, they will receive automated, tailored instructions for how to improve their sleep.', 'interventionNames': ['Behavioral: SHUTi (Sleep Healthy Using the Internet)']}], 'interventions': [{'name': 'SHUTi (Sleep Healthy Using the Internet)', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive-behavioral therapy for insomnia', 'CBT-I'], 'description': 'Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program', 'armGroupLabels': ['SHUTi (Sleep Healthy Using the Internet)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'url': 'https://bit.ly/SHUTiCARE-project', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'De-identified row-level data are available via data use agreement with the University of Virginia per institutional requirements; contact the primary investigator to initiate the contracting process.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kelly Shaffer, PhD', 'investigatorAffiliation': 'University of Virginia'}}}}