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Behavioural Intervention

CBT + Trazodone for Insomnia

Phase < 1

Recruiting

Led By Alexandros Vgontzas, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Be older than 18 years old

Must not have

Age < 18

Life time diagnosis of psychotic or bipolar disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 weeks

Summary

This trial aims to compare how individuals with insomnia and short sleep duration differ from those with normal sleep duration in terms of health risks and response to treatment. The study will investigate the effectiveness of two common insomnia

Who is the study for?

This trial is for adults with chronic insomnia, particularly those who sleep less than normal (ISS) or have a normal sleep duration (INS), and also have high blood pressure. Participants should not be currently using other treatments for insomnia.

What is being tested?

The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I), which is a non-drug treatment focusing on changing sleep habits, versus Trazodone, a low-dose medication that helps with sleep without forming habits. The effectiveness of these treatments will be compared.

What are the potential side effects?

Possible side effects from Trazodone include drowsiness during the day, dizziness, constipation, blurred vision, and dry mouth. CBT-I generally does not cause physical side effects but may require time commitment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have never been diagnosed with a psychotic or bipolar disorder.

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I have been diagnosed with narcolepsy or hypersomnia.

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I have not had a fall causing hospitalization or serious injury in the last year.

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I've been hospitalized or visited the ER twice in the last year for a chronic condition.

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I am currently receiving chemotherapy or radiation for my cancer.

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I have been diagnosed with sleep apnea or leg movement disorder.

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I am currently using a PAP machine for my sleep.

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I do not have chronic insomnia.

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I have never been diagnosed with or treated for chronic kidney failure, liver problems, or chronic heart failure.

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I agree to only use the insomnia treatments provided in this study.

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I use sleep medication more than twice a week.

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I am currently taking steroids or opiate painkillers.

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I am not taking any medications that can't be used with trazodone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment

Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)

Secondary study objectives

Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)

Actigraphy Total Sleep Time (TST) following RCT

Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with TrazodoneActive Control2 Interventions

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.

Group II: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placeboPlacebo Group2 Interventions

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.

0 / 15Eligibility criteria met