Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
- Conditions
- InsomniaBlood PressureBlood Pressure, HighInsomnia ChronicInsomnia, Primary
- Interventions
- Registration Number
- NCT06281756
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Age 18 or older
- 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.
- Meets criteria for chronic insomnia
- Body Mass Index (BMI) 18.5 kg/m2 and higher
- Age < 18
- 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.
- Unwilling to share email address/cell phone number to accept survey links.
- Life time diagnosis of psychotic or bipolar disorder
- Current use of supplemental oxygen for the treatment of sleep apnea
- 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.
- Started new or changed treatment for sleep apnea in the past three months
- Does not meet criteria for chronic insomnia
- Meets criteria for narcolepsy or hypersomnia disorder
- Meets criteria for circadian rhythm disorder (including night shift work)
- Unstable medical conditions that would make participation unsafe or unfeasible
- Falls resulting in hospitalization, significant injury or fracture within past 12 months
- 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
- Active chemotherapy or radiation therapy for cancer
- Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
- Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
- BMI less than 18.5
- Substance abuse or dependence in the past 12 months
- Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
- Current use of systemic corticosteroids or opiate medications
- Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
- Current use of medications contraindicated with trazodone
- Sleep apnea or periodic leg movement disorder as determined by sleep study
- Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
- EKG corrected QT interval greater than or equal to 500 ms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone Cognitive Behavioral Treatment for Insomnia (CBT-I) Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks. Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo Cognitive Behavioral Treatment for Insomnia (CBT-I) Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks. Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo Placebo Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks. Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone Trazodone Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
- Primary Outcome Measures
Name Time Method Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) 9 weeks Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment 35 weeks Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) 9 weeks Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
- Secondary Outcome Measures
Name Time Method Evening Cortisol levels following CBT-I 9 weeks Cortisol levels measured in saliva collected following CBT-I
Evening Cortisol levels following RCT 9 weeks Cortisol levels measured in saliva collected following RCT
Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) 9 weeks Morning DBP Blood Pressure Readings measured at home (7 day period)
Insomnia Severity Index (ISI) Score following CBT-I 9 weeks 0-28, with 0 being mild and 28 being severe
Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) 9 weeks Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study
Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) 9 weeks Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)
PSG Total Sleep Time (TST) following RCT 9 weeks PSG Total Sleep Time measured in minutes asleep during sleep study following RCT
Actigraphy Total Sleep Time (TST) following RCT 9 weeks Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT
Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) 9 weeks Morning SBP Blood Pressure Readings measured at home (7 day period)
Insomnia Severity Index (ISI) Score following RCT 9 weeks 0-28, with 0 being mild and 28 being severe
Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment 35 weeks Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment
Trial Locations
- Locations (4)
National Jewish Health
🇺🇸Denver, Colorado, United States
Penn State University
🇺🇸Hershey, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Université Laval
🇨🇦Quebec, Canada