protocolSection identificationModule nctId: NCT06281756, orgStudyIdInfo id: STUDY00022285, secondaryIdInfos id: 1UG3HL161342-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3HL161342-01A1, briefTitle: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), 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., conditionsModule conditions: Insomnia, conditions: Insomnia Chronic, conditions: Insomnia, Primary, conditions: Blood Pressure, conditions: Blood Pressure, High, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Both prescribing physicians and participants will be blind to phenotype and treatment groups., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Treatment for Insomnia (CBT-I), interventions name: Trazodone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I), primaryOutcomes measure: Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT), primaryOutcomes measure: Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score following CBT-I, secondaryOutcomes measure: Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I), secondaryOutcomes measure: Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I), secondaryOutcomes measure: Evening Cortisol levels following CBT-I, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score following RCT, secondaryOutcomes measure: PSG Total Sleep Time (TST) following RCT, secondaryOutcomes measure: Actigraphy Total Sleep Time (TST) following RCT, secondaryOutcomes measure: Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP), secondaryOutcomes measure: Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP), secondaryOutcomes measure: Evening Cortisol levels following RCT, secondaryOutcomes measure: Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Jewish Health, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80206-2761, country: United States, contacts name: Roxane Horberg, role: CONTACT, phone: 303-270-2850, email: horbergr@njhealth.org, contacts name: Rachel Johnson, role: CONTACT, phone: 303 398-1058, email: johnsonr@njhealth.org, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Penn State University, status: RECRUITING, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts name: Carrie Criley, role: CONTACT, phone: 717-531-4123, email: ccriley@pennstatehealth.psu.edu, geoPoint lat: 40.28592, lon: -76.65025, locations facility: University of Pittsburgh, status: NOT_YET_RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15213-3203, country: United States, contacts name: Laurie Brar, role: CONTACT, phone: 412-723-7998, email: brarlk@upmc.edu, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Université Laval, status: NOT_YET_RECRUITING, city: Quebec, zip: G1V 0A6, country: Canada, contacts name: Manon Lamy, role: CONTACT, phone: 418 656-2131, phoneExt: 412467, email: manon.lamy@psy.ulaval.ca, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False