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Completed

NCT Number: NCT01348542

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trazodone

Drug

50 mg once a day, for 3 months

Cognitive behavioral therapy

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 5, 2011
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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