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