Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348542
• Other study ID #: 35933
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: June 1, 2018

Study information

• Verified date: February 2020
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

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.

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)