Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01348542
Collaborator
(none)
24
1
2
86
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration
Actual Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Trazodone

Drug: Trazodone
50 mg once a day, for 3 months

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) [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) [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) [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) [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

  1. Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033

Sponsors and Collaborators

  • Milton S. Hershey Medical Center

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Alexandros Vgontzas, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01348542
Other Study ID Numbers:
  • 35933
First Posted:
May 5, 2011
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020
Keywords provided by Alexandros Vgontzas, Principal Investigator, Milton S. Hershey Medical Center
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Period Title: Overall Study
STARTED 13 11
COMPLETED 10 11
NOT COMPLETED 3 0

Baseline Characteristics

Arm/Group Title Trazodone Cognitive Behavioral Therapy Total
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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. Total of all reporting groups
Overall Participants 10 11 21
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
10
100%
11
100%
21
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
42.6
(8.75)
45.27
(9.94)
44.0
(9.26)
Sex: Female, Male (Count of Participants)
Female
9
90%
10
90.9%
19
90.5%
Male
1
10%
1
9.1%
2
9.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
1
10%
1
9.1%
2
9.5%
White
9
90%
9
81.8%
18
85.7%
More than one race
0
0%
1
9.1%
1
4.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
United States
10
100%
11
100%
21
100%
Insomnia Severity Index (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]
16.70
(3.59)
16.18
(2.18)
16.43
(2.87)

Outcome Measures

1. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
Objective Short Sleepers defined by 2 week actigraphy sleep duration measurement
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Measure Participants 7 8
Mean (Standard Deviation) [minutes]
28.95
(31.70)
38.91
(24.74)
2. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Measure Participants 7 8
Mean (Standard Deviation) [minutes]
51.78
(76.39)
32.36
(30.31)
3. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Measure Participants 7 8
Mean (Standard Deviation) [minutes]
51.01
(57.50)
-11.73
(31.43)
4. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Measure Participants 7 8
Mean (Standard Deviation) [minutes]
50.35
(27.47)
-7.56
(38.04)
5. Secondary Outcome
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)

Outcome Measure Data

Analysis Population Description
From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Measure Participants 7 8
Mean (Standard Deviation) [score on a scale]
-12.29
(4.35)
-10.75
(2.87)
6. Secondary Outcome
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)

Outcome Measure Data

Analysis Population Description
From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
Measure Participants 7 8
Mean (Standard Deviation) [score on a scale]
-13.29
(3.77)
-10.38
(3.02)

Adverse Events

Time Frame 9 months
Adverse Event Reporting Description
Arm/Group Title Trazodone Cognitive Behavioral Therapy
Arm/Group Description Trazodone: 50 mg once a day, for 3 months 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.
All Cause Mortality
Trazodone Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/11 (0%)
Serious Adverse Events
Trazodone Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/11 (0%)
Other (Not Including Serious) Adverse Events
Trazodone Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Alexandros Vgontzas
Organization Penn State University College of Medicine
Phone 717 531-7278
Email vgontzas@pennstatehealth.psu.edu
Responsible Party:
Alexandros Vgontzas, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01348542
Other Study ID Numbers:
  • 35933
First Posted:
May 5, 2011
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020