Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT06281756
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2024-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014196', 'term': 'Trazodone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Both prescribing physicians and participants will be blind to phenotype and treatment groups.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)', 'timeFrame': '9 weeks', 'description': 'Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe'}, {'measure': 'Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)', 'timeFrame': '9 weeks', 'description': 'Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe'}, {'measure': 'Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment', 'timeFrame': '35 weeks', 'description': 'Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe'}], 'secondaryOutcomes': [{'measure': 'Insomnia Severity Index (ISI) Score following CBT-I', 'timeFrame': '9 weeks', 'description': '0-28, with 0 being mild and 28 being severe'}, {'measure': 'Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)', 'timeFrame': '9 weeks', 'description': 'Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study'}, {'measure': 'Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)', 'timeFrame': '9 weeks', 'description': 'Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)'}, {'measure': 'Evening Cortisol levels following CBT-I', 'timeFrame': '9 weeks', 'description': 'Cortisol levels measured in saliva collected following CBT-I'}, {'measure': 'Insomnia Severity Index (ISI) Score following RCT', 'timeFrame': '9 weeks', 'description': '0-28, with 0 being mild and 28 being severe'}, {'measure': 'PSG Total Sleep Time (TST) following RCT', 'timeFrame': '9 weeks', 'description': 'PSG Total Sleep Time measured in minutes asleep during sleep study following RCT'}, {'measure': 'Actigraphy Total Sleep Time (TST) following RCT', 'timeFrame': '9 weeks', 'description': 'Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT'}, {'measure': 'Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)', 'timeFrame': '9 weeks', 'description': 'Morning SBP Blood Pressure Readings measured at home (7 day period)'}, {'measure': 'Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)', 'timeFrame': '9 weeks', 'description': 'Morning DBP Blood Pressure Readings measured at home (7 day period)'}, {'measure': 'Evening Cortisol levels following RCT', 'timeFrame': '9 weeks', 'description': 'Cortisol levels measured in saliva collected following RCT'}, {'measure': 'Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment', 'timeFrame': '35 weeks', 'description': 'Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'sleep disorder', 'insomnia'], 'conditions': ['Insomnia', 'Insomnia Chronic', 'Insomnia, Primary', 'Blood Pressure', 'Blood Pressure, High']}, 'descriptionModule': {'briefSummary': "Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.\n* Meets criteria for chronic insomnia\n* Body Mass Index (BMI) 18.5 kg/m2 and higher\n\nExclusion Criteria:\n\n* Age \\< 18\n* Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.\n* Unwilling to share email address/cell phone number to accept survey links.\n* Life time diagnosis of psychotic or bipolar disorder\n* History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.\n* Started new or changed treatment for sleep apnea in the past three months\n* Does not meet criteria for chronic insomnia\n* Meets criteria for narcolepsy or hypersomnia disorder\n* Meets criteria for circadian rhythm disorder (including night shift work)\n* Unstable medical conditions that would make participation unsafe or unfeasible\n* Falls resulting in hospitalization, significant injury or fracture within past 12 months\n* 2 hospitalizations or emergency room visits within past 12 months for chronic conditions\n* Active chemotherapy or radiation therapy for cancer\n* Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure\n* Does not agree to refrain from other treatments for insomnia beyond what is offered in this study\n* BMI less than 18.5\n* Substance abuse or dependence in the past 12 months\n* Current use of prescription or over the counter medications taken for sleep greater than 2 times per week\n* Current use of systemic corticosteroids or opiate medications\n* Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study\n* Current use of medications contraindicated with trazodone\n* Sleep apnea or periodic leg movement disorder as determined by sleep study\n* Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg\n* EKG corrected QT interval greater than or equal to 500 ms'}, 'identificationModule': {'nctId': 'NCT06281756', 'briefTitle': 'Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00022285'}, 'secondaryIdInfos': [{'id': '1UG3HL161342-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1UG3HL161342-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo', 'description': 'Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.', 'interventionNames': ['Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I)', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone', 'description': 'Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.', 'interventionNames': ['Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I)', 'Drug: Trazodone']}], 'interventions': [{'name': 'Cognitive Behavioral Treatment for Insomnia (CBT-I)', 'type': 'BEHAVIORAL', 'description': 'Subjects will receive therapy for 8 weeks', 'armGroupLabels': ['Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone', 'Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo']}, {'name': 'Trazodone', 'type': 'DRUG', 'description': 'Non-remitting subjects will receive Trazodone (dosage) for 8 weeks', 'armGroupLabels': ['Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Non-remitting subjects will receive placebo for 8 weeks', 'armGroupLabels': ['Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206-2761', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roxane Horberg', 'role': 'CONTACT', 'email': 'horbergr@njhealth.org', 'phone': '303-270-2850'}, {'name': 'Rachel Johnson', 'role': 'CONTACT', 'email': 'johnsonr@njhealth.org', 'phone': '303 398-1058'}], 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carrie Criley', 'role': 'CONTACT', 'email': 'ccriley@pennstatehealth.psu.edu', 'phone': '717-531-4123'}], 'facility': 'Penn State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15213-3203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laurie Brar', 'role': 'CONTACT', 'email': 'brarlk@upmc.edu', 'phone': '412-723-7998'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Manon Lamy', 'role': 'CONTACT', 'email': 'manon.lamy@psy.ulaval.ca', 'phone': '418 656-2131', 'phoneExt': '412467'}], 'facility': 'Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Carrie Criley', 'role': 'CONTACT', 'email': 'ccriley@pennstatehealth.psu.edu', 'phone': '717-531-4123'}], 'overallOfficials': [{'name': 'Alexandros Vgontzas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Psychiatry'}]}, 'ipdSharingStatementModule': {'url': 'https://biolincc.nhlbi.nih.gov/home/', 'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'Data collected for aim 1 (an observational study) and aim 2 (a randomized clinical trial) will be made available no more than 3 years after the completion of the last follow-up assessment. Data will be submitted to the Program Officer and uploaded to the NHLBI BioLINCC repository no later than 3 years after the end of clinical activity or 2 years after the main outcomes paper is published, whichever comes first.', 'ipdSharing': 'YES', 'description': 'The investigators have extensive experience preparing data and documentation to be available for public. They agree to abide by the principles for sharing research resources described by the National Heart, Lung, Blood Institute (NHLBI). A copy of the data will be uploaded to the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) repository. The datasets will not include any personal identifiers related to participants or clinical sites. Dates will be de-identified through a date-shifting algorithm to mask actual dates while maintaining a relation to the epoch in which events occurred. Data tables will be exported in comma-separated format, readable by statistical software. Variable dictionaries and code books, detailing variable description, format, value domain and labels, will be produced. Raw data files for polysomnogram/actigraphy/cortisol will also be made available, ensuring that data are linkable to study data and data are de-identified.', 'accessCriteria': 'NHLBI BioLINCC repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Psychiatry', 'investigatorFullName': 'Alexandros Vgontzas', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}