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)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 86
• Patients Per Site Per Month: 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
Insomnia	Drug: Trazodone; Behavioral: Cognitive Behavioral Therapy	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)

• Study Protocol and Statistical Analysis Plan - Jan 3, 2019

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernández-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64.
• 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.

• 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: Chronic Insomnia; Short Sleep Duration; Trazodone; Cognitive Behavioral Therapy; Efficacy
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Trazodone

Study Results

Participant Flow

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
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.