Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Trazodone
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Objective Polysomnography Sleep Duration From 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) | 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) | 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) | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Insomnia, Short Sleep Duration, Trazodone, Cognitive Behavioral Therapy, Efficacy