Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT03724305
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduce Emotional Symptoms of Insomnia With SleepTreatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D000079562', 'term': 'Rumination Syndrome'}, {'id': 'D003863', 'term': 'Depression'}], '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'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'csagong1@hfhs.org', 'phone': '2483442409', 'title': 'Chaewon Sagong', 'organization': 'Henry Ford Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Subjects' self-report during treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)", 'description': "The definition of adverse event and/or serious adverse event, used to collect adverse event information, doesn't differ from the clinical trials.gov definitions.", 'eventGroups': [{'id': 'EG000', 'title': 'MBTI', 'description': 'Mindfulness-Based Therapy for Insomnia\n\nMindfulness-Based Therapy for Insomnia: Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insomnia Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTI', 'description': 'Mindfulness-Based Therapy for Insomnia\n\nMindfulness-Based Therapy for Insomnia: Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '16.42', 'spread': '3.95', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment (7 weeks following initiation of treatment)', 'categories': [{'measurements': [{'value': '8.37', 'spread': '4.19', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up (6 months following completion of treatment)', 'categories': [{'measurements': [{'value': '11.72', 'spread': '4.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)', 'description': 'Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.'}, {'type': 'PRIMARY', 'title': 'Five Facet Mindfulness Questionnaire-15 (FFMQ-15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MBTI', 'description': 'Mindfulness-Based Therapy for Insomnia\n\nMindfulness-Based Therapy for Insomnia: Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '52.95', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '57.42', 'spread': '9.87', 'groupId': 'OG000'}]}]}, {'title': '6 months follow-up', 'categories': [{'measurements': [{'value': '55.50', 'spread': '10.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)', 'description': 'Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MBTI', 'description': 'Mindfulness-Based Therapy for Insomnia\n\nMindfulness-Based Therapy for Insomnia: Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MBTI', 'description': 'Mindfulness-Based Therapy for Insomnia\n\nMindfulness-Based Therapy for Insomnia: Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.16', 'spread': '14.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Others', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insomnia Severity Index', 'classes': [{'categories': [{'measurements': [{'value': '16.42', 'spread': '3.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Insomnia Severity Index (ISI) Scale is a self-report measure of insomnia symptom severity. Range is 0 to 28, high score indicating a greater insomnia severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Five Facet Mindfulness Questionnaire-15 (FFMQ-15)', 'classes': [{'categories': [{'measurements': [{'value': '52.95', 'spread': '8.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Five Facet Mindfulness Questionnaire-15 measures everyday levels of mindfulness. Scale ranges from 15 to 75 with higher scores indicating a greater level of mindfulness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-08', 'size': 819562, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-19T14:19', 'hasProtocol': True}, {'date': '2021-03-26', 'size': 219052, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-19T14:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2018-10-25', 'resultsFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-27', 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': 'Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)', 'description': 'Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)'}, {'measure': 'Five Facet Mindfulness Questionnaire-15 (FFMQ-15)', 'timeFrame': 'Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)', 'description': 'Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insomnia', 'nocturnal rumination', 'depression', 'mindfulness', 'mindfulness-based therapy for insomnia'], 'conditions': ['Insomnia', 'Rumination']}, 'referencesModule': {'references': [{'pmid': '41426462', 'type': 'DERIVED', 'citation': 'Kalmbach DA, Cheng P, Ong JC, Reffi AN, Fresco DM, Fellman-Couture C, Ruprich MK, Sultan Z, Sagong C, Drake CL. Mindfulness-based therapy for insomnia alleviates insomnia, depression, and cognitive arousal in treatment-resistant insomnia: A single-arm telemedicine trial. Front Sleep. 2023 Mar 8;2:1072752. doi: 10.3389/frsle.2023.1072752. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.', 'detailedDescription': 'Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.\n\nThis trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.\n\nMale and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Determination of insomnia (ISI\\>10)\n* Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.\n\nExclusion Criteria:\n\n* Age \\< 18\n* Current use of antidepressants for depression\n* Bipolar or Seizure disorders\n* Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).'}, 'identificationModule': {'nctId': 'NCT03724305', 'acronym': 'RESIST', 'briefTitle': 'Reduce Emotional Symptoms of Insomnia With SleepTreatment', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Reduce Emotional Symptoms of Insomnia With Sleep Treatment', 'orgStudyIdInfo': {'id': 'RESIST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBTI', 'description': 'Mindfulness-Based Therapy for Insomnia', 'interventionNames': ['Behavioral: Mindfulness-Based Therapy for Insomnia']}], 'interventions': [{'name': 'Mindfulness-Based Therapy for Insomnia', 'type': 'BEHAVIORAL', 'otherNames': ['MBTI'], 'description': 'Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.', 'armGroupLabels': ['MBTI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48377', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System - Columbus', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}], 'overallOfficials': [{'name': 'Christopher L Drake, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Drake', 'investigatorAffiliation': 'Henry Ford Health System'}}}}