Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-27 @ 6:18 PM
Study NCT ID:
NCT01933295
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2012-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Sponsor:
Organization:
Raw JSON
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'29.90', 'spread': '12.08', 'groupId': 'OG002'}]}]}, {'title': '6 months follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.31', 'spread': '10.95', 'groupId': 'OG000'}, {'value': '25.35', 'spread': '10.41', 'groupId': 'OG001'}, {'value': '28.49', 'spread': '10.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months', 'description': 'Scores range from 9 to 63, with higher scores indicating greater fatigue, and scores above 36 indicate severe fatigue.\n\nData collected at pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Lost to follow-up at 6 months follow-up assessment'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sleep Education', 'description': 'Weekly educational emails sent to participants with information about sleep science and tips for better sleep.\n\nSleep Education'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy for Insomnia', 'description': 'Behavioral treatment (5 component)\n\nCognitive Behavioral Therapy for Insomnia'}, {'id': 'OG002', 'title': 'Sleep Restriction Therapy', 'description': 'Brief sleep restriction therapy.\n\nSleep Restriction Therapy'}], 'classes': [{'title': 'Pre-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': 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'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 months', 'description': 'Domain scores range from 0 to 100 with higher scores indicating better quality of life.\n\nData collected at each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Lost to follow-up at 6 months follow-up assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sleep Education', 'description': 'Weekly educational emails sent to participants with information about sleep science and tips for better sleep.\n\nSleep Education'}, {'id': 'FG001', 'title': 'Cognitive Behavioral Therapy for Insomnia', 'description': 'Behavioral (sleep restriction and stimulus control) and cognitive (eg, cognitive restructuring) components, as well as relaxation 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Scores in this study represent the daily mean for sleepiness ratings for each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)'}], 'secondaryOutcomes': [{'measure': 'Fatigue Severity Scale (FSS).', 'timeFrame': '8 months', 'description': 'Scores range from 9 to 63, with higher scores indicating greater fatigue, and scores above 36 indicate severe fatigue.\n\nData collected at pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline).'}, {'measure': 'Medical Outcomes Study Short Form Health Survey (SF-36), Energy Subscale', 'timeFrame': '8 months', 'description': 'Domain scores range from 0 to 100 with higher scores indicating better quality of life.\n\nData collected at each assessment period: "pre-treatment (baseline), post-treatment (approximately 4 weeks after baseline), and 6 month follow-up (approximately 7-8 months after baseline)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['treatment'], 'conditions': ['Menopause']}, 'referencesModule': {'references': [{'pmid': '32799029', 'type': 'DERIVED', 'citation': 'Kalmbach DA, Cheng P, Roth T, Sagong C, Drake CL. Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women. Sleep Med. 2020 Sep;73:82-92. doi: 10.1016/j.sleep.2020.04.024. Epub 2020 May 7.'}, {'pmid': '31992407', 'type': 'DERIVED', 'citation': 'Cheng P, Kalmbach D, Fellman-Couture C, Arnedt JT, Cuamatzi-Castelan A, Drake CL. Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial. J Clin Sleep Med. 2020 Feb 15;16(2):193-198. doi: 10.5664/jcsm.8164. Epub 2020 Jan 13.'}, {'pmid': '31383238', 'type': 'DERIVED', 'citation': 'Kalmbach DA, Cheng P, Arnedt JT, Cuamatzi-Castelan A, Atkinson RL, Fellman-Couture C, Roehrs T, Drake CL. Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education. J Clin Sleep Med. 2019 Jul 15;15(7):999-1010. doi: 10.5664/jcsm.7882.'}, {'pmid': '30785053', 'type': 'DERIVED', 'citation': 'Kalmbach DA, Cheng P, Arnedt JT, Anderson JR, Roth T, Fellman-Couture C, Williams RA, Drake CL. Treating insomnia improves depression, maladaptive thinking, and hyperarousal in postmenopausal women: comparing cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy, and sleep hygiene education. Sleep Med. 2019 Mar;55:124-134. doi: 10.1016/j.sleep.2018.11.019. Epub 2018 Dec 28.'}, {'pmid': '30481333', 'type': 'DERIVED', 'citation': 'Drake CL, Kalmbach DA, Arnedt JT, Cheng P, Tonnu CV, Cuamatzi-Castelan A, Fellman-Couture C. Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. Sleep. 2019 Feb 1;42(2):zsy217. doi: 10.1093/sleep/zsy217.'}]}, 'descriptionModule': {'briefSummary': 'Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.', 'detailedDescription': 'Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.\n\nSpecific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.\n\nSpecific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).\n\nSpecific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* post-menopausal insomnia\n\nExclusion Criteria:\n\n* unstable medical conditions'}, 'identificationModule': {'nctId': 'NCT01933295', 'briefTitle': 'Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes', 'orgStudyIdInfo': {'id': 'NR013959'}, 'secondaryIdInfos': [{'id': 'R01NR013959-01', 'link': 'https://reporter.nih.gov/quickSearch/R01NR013959-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Education', 'description': 'Weekly educational emails sent to participants with information about sleep science and tips for better sleep.', 'interventionNames': ['Behavioral: Sleep Education']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy for Insomnia', 'description': 'Behavioral treatment (5 component)', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Insomnia']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep Restriction Therapy', 'description': 'Brief sleep restriction therapy.', 'interventionNames': ['Behavioral: Sleep Restriction Therapy']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy for Insomnia', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Cognitive Behavioral Therapy for Insomnia']}, {'name': 'Sleep Education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Sleep Education']}, {'name': 'Sleep Restriction Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Sleep Restriction Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Christopher Drake, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher Drake', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'Wayne State University', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Bioscientific Staff', 'investigatorFullName': 'Christopher Drake', 'investigatorAffiliation': 'Henry Ford Health System'}}}}