NCT01348542

Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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, with a 6 month follow up. 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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Trazodone	50 mg once a day, for 3 months
BEHAVIORAL	Cognitive Behavioral Therapy	The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.

Timeline

• Start date: 2011-04-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2011-05-05
• Last updated: 2020-02-25
• Results posted: 2019-06-21

Locations

1 site across 1 country: United States