Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Drug: Trazodone; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT01348542
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Results First Submitted: 2019-05-28
• Results First Submitted QC: 2019-05-28
• Results First Posted: 2019-06-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trazodone	Trazodone	-
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)	Baseline to Post Treatment (3 months)	Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)
Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)	Baseline to follow up (9 months)	Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)	Baseline to Post Treatment (3 months)	Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)
Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)	Baseline to follow up (9 months)	Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months	Baseline to Post Treatment (3 months)	The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to post treatment (3 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.
Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months	Baseline to follow up (9 months)	The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to Follow Up (9 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States