Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Penn State Health

Status: Completed

Conditions: Insomnia

Treatments: Drug: Trazodone; Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01348542

35933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic insomnia with duration of more than 1 year
• Objective short sleep duration (< 6 hours)
• BMI < 39
• Ages 30-60
• Men & Women

Exclusion criteria

• Major Mental Illness
• Substance Abuse/Dependence
• Sleep Apnea
• Periodic Limb Movement Disorder
• Shift Work or circadian disorders
• Diabetes
• Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure
• Current Use of hypnotics or sleep inducing sedative antidepressants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Trazodone

Active Comparator group

Treatment:

Drug: Trazodone

Cognitive Behavioral Therapy

Active Comparator group

Treatment:

Behavioral: Cognitive Behavioral Therapy