Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration|
- Change from Baseline in objective sleep duration at 9 months [ Time Frame: Baseline, 3 months & 9 months ] [ Designated as safety issue: No ]Polysomnography & Actigraphy will be used to measure sleep duration at baseline, post treatment (3 months) and follow-up (9 months).
- Change from Baseline in Subjective Severity of Sleep Disturbance & Subjective Sleep Duration at 9 months [ Time Frame: Baseline, 3 months & 9 months ] [ Designated as safety issue: No ]Sleep Diary and subjective questionnaires will be used to measure severity of sleep disturbance and subjective sleep duration at baseline, post treatment (3 months) and follow-up (9 months).
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Trazodone||
50 mg once a day, for 3 months
|Active Comparator: Cognitive Behavioral Therapy||
Behavioral: Cognitive Behavioral Therapy
The CBT Protocol is implemented over a period of 12 weeks, with consultations held on a weekly basis.
Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance and subjective sleep duration.
|Contact: Carrie A Criley, BA, RPSGT||717 firstname.lastname@example.org|
|Contact: Julio Fernandez-Mendoza, PhD||717 531-0003 ext email@example.com|
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Carrie A Criley, BA, RPSGT 717-531-4123 firstname.lastname@example.org|
|Contact: Julio Fernandez-Mendoza, PhD 717 531-0003 ext 285570 email@example.com|
|Principal Investigator: Alexandros N Vgontzas, MD|
|Principal Investigator:||Alexandros N Vgontzas, MD||Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|