Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

February 14, 2020 updated by: Alexandros Vgontzas, Milton S. Hershey Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive Behavioral Therapy
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.
Active Comparator: Trazodone
Drug: Trazodone
50 mg once a day, for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)
Time Frame: 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)
Baseline to Post Treatment (3 months)
Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)
Time Frame: 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)
Baseline to follow up (9 months)
Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)
Time Frame: 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)
Baseline to Post Treatment (3 months)
Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)
Time Frame: 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)
Baseline to follow up (9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months
Time Frame: 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.
Baseline to Post Treatment (3 months)
Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months
Time Frame: 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.
Baseline to follow up (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Alexandros N Vgontzas, MD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35933

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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