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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
600
National Jewish Health
Denver, Colorado, United States
RECRUITINGPenn State University
Hershey, Pennsylvania, United States
RECRUITINGUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
RECRUITINGUniversité Laval
Québec, Quebec, Canada
RECRUITINGRemission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Time frame: 9 weeks
Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Time frame: 9 weeks
Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
Based on Insomnia Severity Index (ISI) published criteria; 0-28, with 0 being mild and 28 being severe
Time frame: 35 weeks
Insomnia Severity Index (ISI) Score following CBT-I
0-28, with 0 being mild and 28 being severe
Time frame: 9 weeks
Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Polysomnography (PSG) Sleep efficiency measured as a percentage of time asleep during sleep study
Time frame: 9 weeks
Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
Actigraphy Sleep efficiency measured as estimated sleep time at home (2 week period)
Time frame: 9 weeks
Evening Cortisol levels following CBT-I
Cortisol levels measured in saliva collected following CBT-I
Time frame: 9 weeks
Insomnia Severity Index (ISI) Score following RCT
0-28, with 0 being mild and 28 being severe
Time frame: 9 weeks
PSG Total Sleep Time (TST) following RCT
PSG Total Sleep Time measured in minutes asleep during sleep study following RCT
Time frame: 9 weeks
Actigraphy Total Sleep Time (TST) following RCT
Actigraphy Total Sleep Time measured in minutes asleep during home study following RCT
Time frame: 9 weeks
Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)
Morning SBP Blood Pressure Readings measured at home (7 day period)
Time frame: 9 weeks
Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)
Morning DBP Blood Pressure Readings measured at home (7 day period)
Time frame: 9 weeks
Evening Cortisol levels following RCT
Cortisol levels measured in saliva collected following RCT
Time frame: 9 weeks
Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment
Cortisol levels measured in saliva 6 months following CBT-I Or RCT Treatment
Time frame: 35 weeks
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