An interventional study of Trazodone and Cognitive Behavioral Therapy in Insomnia, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 24 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
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Exclusion Criteria:
Drug: Trazodone
Behavioral: Cognitive Behavioral Therapy
50 mg once a day, for 3 months
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.
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to follow up (9 months)
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.
Time frame: 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.
Time frame: Baseline to follow up (9 months)
| Milestone | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Started | 13 | 11 |
| Completed | 10 | 11 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 3 | 0 |
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)
| minutes | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) | 28.95 ± 31.70 | 38.91 ± 24.74 |
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
| minutes | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months) | 51.78 ± 76.39 | 32.36 ± 30.31 |
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)
| minutes | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months) | 51.01 ± 57.50 | -11.73 ± 31.43 |
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
| minutes | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months) | 50.35 ± 27.47 | -7.56 ± 38.04 |
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.
| score on a scale | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months | -12.29 ± 4.35 | -10.75 ± 2.87 |
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.
| score on a scale | Trazodone | Cognitive Behavioral Therapy |
|---|---|---|
| Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months | -13.29 ± 3.77 | -10.38 ± 3.02 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trazodone | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Cognitive Behavioral Therapy | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 11 | 21 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Mean | 42.6 ± 8.75 | 45.27 ± 9.94 | 44.0 ± 9.26 |
| Sex: Female, Male(Participants) | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 9 | 9 | 18 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| United States | 10 | 11 | 21 |
| Insomnia Severity Index(score on a scale) | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Mean | 16.70 ± 3.59 | 16.18 ± 2.18 | 16.43 ± 2.87 |
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Sleep Initiation and Maintenance Disorders→
Milton S. Hershey Medical Center