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Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trazodone
Cognitive Behavioral Therapy
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Chronic Insomnia, Short Sleep Duration, Trazodone, Cognitive Behavioral Therapy, Efficacy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trazodone

Cognitive Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 20, 2011
Last Updated
February 14, 2020
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01348542
Brief Title
Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
Official Title
Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Chronic Insomnia, Short Sleep Duration, Trazodone, Cognitive Behavioral Therapy, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trazodone
Arm Type
Active Comparator
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
50 mg once a day, for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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 Outcome Measure Information:
Title
Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)
Description
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)
Time Frame
Baseline to Post Treatment (3 months)
Title
Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)
Description
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
Time Frame
Baseline to follow up (9 months)
Title
Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)
Description
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)
Time Frame
Baseline to Post Treatment (3 months)
Title
Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)
Description
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
Time Frame
Baseline to follow up (9 months)
Secondary Outcome Measure Information:
Title
Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months
Description
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.
Time Frame
Baseline to Post Treatment (3 months)
Title
Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months
Description
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.
Time Frame
Baseline to follow up (9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandros N Vgontzas, MD
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20857861
Citation
Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159.
Results Reference
background
PubMed Identifier
19641160
Citation
Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Bixler EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: A population-based study. Diabetes Care. 2009 Nov;32(11):1980-5. doi: 10.2337/dc09-0284. Epub 2009 Jul 29.
Results Reference
background
PubMed Identifier
19413143
Citation
Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009 Apr;32(4):491-7. doi: 10.1093/sleep/32.4.491.
Results Reference
background
PubMed Identifier
11502812
Citation
Vgontzas AN, Bixler EO, Lin HM, Prolo P, Mastorakos G, Vela-Bueno A, Kales A, Chrousos GP. Chronic insomnia is associated with nyctohemeral activation of the hypothalamic-pituitary-adrenal axis: clinical implications. J Clin Endocrinol Metab. 2001 Aug;86(8):3787-94. doi: 10.1210/jcem.86.8.7778.
Results Reference
background
PubMed Identifier
20394314
Citation
Fernandez-Mendoza J, Calhoun S, Bixler EO, Pejovic S, Karataraki M, Liao D, Vela-Bueno A, Ramos-Platon MJ, Sauder KA, Vgontzas AN. Insomnia with objective short sleep duration is associated with deficits in neuropsychological performance: a general population study. Sleep. 2010 Apr;33(4):459-65. doi: 10.1093/sleep/33.4.459.
Results Reference
background
PubMed Identifier
20978224
Citation
Fernandez-Mendoza J, Calhoun SL, Bixler EO, Karataraki M, Liao D, Vela-Bueno A, Jose Ramos-Platon M, Sauder KA, Basta M, Vgontzas AN. Sleep misperception and chronic insomnia in the general population: role of objective sleep duration and psychological profiles. Psychosom Med. 2011 Jan;73(1):88-97. doi: 10.1097/PSY.0b013e3181fe365a. Epub 2010 Oct 26.
Results Reference
background
PubMed Identifier
33675113
Citation
Li Y, Vgontzas AN, Fernandez-Mendoza J, Fang J, Puzino K, Bixler EO. Effect of trazodone versus cognitive-behavioural treatment on high- and slow-frequency activity during non-rapid eye movement sleep in chronic insomnia: A pilot, randomized clinical trial. J Sleep Res. 2021 Oct;30(5):e13324. doi: 10.1111/jsr.13324. Epub 2021 Mar 5.
Results Reference
derived
PubMed Identifier
32780015
Citation
Vgontzas AN, Puzino K, Fernandez-Mendoza J, Krishnamurthy VB, Basta M, Bixler EO. Effects of trazodone versus cognitive behavioral therapy in the insomnia with short sleep duration phenotype: a preliminary study. J Clin Sleep Med. 2020 Dec 15;16(12):2009-2019. doi: 10.5664/jcsm.8740.
Results Reference
derived

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Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

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