Insomnia
Conditions
Keywords
Chronic Insomnia, Short Sleep Duration, Trazodone, Cognitive Behavioral Therapy, Efficacy
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.
Interventions
DRUGTrazodone
50 mg once a day, for 3 months
BEHAVIORALCognitive 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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trazodone Trazodone: 50 mg once a day, for 3 months | 10 |
| Cognitive Behavioral Therapy 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. | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Trazodone | Cognitive Behavioral Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 8.75 | 45.27 years STANDARD_DEVIATION 9.94 | 44.0 years STANDARD_DEVIATION 9.26 |
| Insomnia Severity Index | 16.70 score on a scale STANDARD_DEVIATION 3.59 | 16.18 score on a scale STANDARD_DEVIATION 2.18 | 16.43 score on a scale STANDARD_DEVIATION 2.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment United States | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
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)
Time frame: Baseline to follow up (9 months)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months) | 50.35 minutes | Standard Deviation 27.47 |
| Cognitive Behavioral Therapy | Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months) | -7.56 minutes | Standard Deviation 38.04 |
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)
Time frame: Baseline to Post Treatment (3 months)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months) | 51.01 minutes | Standard Deviation 57.5 |
| Cognitive Behavioral Therapy | Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months) | -11.73 minutes | Standard Deviation 31.43 |
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)
Time frame: Baseline to follow up (9 months)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months) | 51.78 minutes | Standard Deviation 76.39 |
| Cognitive Behavioral Therapy | Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months) | 32.36 minutes | Standard Deviation 30.31 |
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)
Time frame: Baseline to Post Treatment (3 months)
Population: Objective Short Sleepers defined by 2 week actigraphy sleep duration measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) | 28.95 minutes | Standard Deviation 31.7 |
| Cognitive Behavioral Therapy | Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months) | 38.91 minutes | Standard Deviation 24.74 |
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.
Time frame: Baseline to Post Treatment (3 months)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months | -12.29 score on a scale | Standard Deviation 4.35 |
| Cognitive Behavioral Therapy | Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months | -10.75 score on a scale | Standard Deviation 2.87 |
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.
Time frame: Baseline to follow up (9 months)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trazodone | Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months | -13.29 score on a scale | Standard Deviation 3.77 |
| Cognitive Behavioral Therapy | Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months | -10.38 score on a scale | Standard Deviation 3.02 |