Trial Outcomes & Findings for Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia (NCT NCT01348542)
NCT ID: NCT01348542
Last Updated: 2020-02-25
Results Overview
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)
COMPLETED
NA
24 participants
Baseline to Post Treatment (3 months)
2020-02-25
Participant Flow
Participant milestones
| Measure |
Trazodone
Trazodone: 50 mg once a day, for 3 months
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Trazodone
Trazodone: 50 mg once a day, for 3 months
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
Baseline characteristics by cohort
| Measure |
Trazodone
n=10 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=11 Participants
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
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
45.27 years
STANDARD_DEVIATION 9.94 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Insomnia Severity Index
|
16.70 score on a scale
STANDARD_DEVIATION 3.59 • n=5 Participants
|
16.18 score on a scale
STANDARD_DEVIATION 2.18 • n=7 Participants
|
16.43 score on a scale
STANDARD_DEVIATION 2.87 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Post Treatment (3 months)Population: Objective Short Sleepers defined by 2 week actigraphy sleep duration measurement
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)
Outcome measures
| Measure |
Trazodone
n=7 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=8 Participants
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.
|
|---|---|---|
|
Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)
|
28.95 minutes
Standard Deviation 31.70
|
38.91 minutes
Standard Deviation 24.74
|
PRIMARY outcome
Timeframe: 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.
Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
Outcome measures
| Measure |
Trazodone
n=7 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=8 Participants
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.
|
|---|---|---|
|
Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)
|
51.78 minutes
Standard Deviation 76.39
|
32.36 minutes
Standard Deviation 30.31
|
PRIMARY outcome
Timeframe: 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.
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)
Outcome measures
| Measure |
Trazodone
n=7 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=8 Participants
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.
|
|---|---|---|
|
Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)
|
51.01 minutes
Standard Deviation 57.50
|
-11.73 minutes
Standard Deviation 31.43
|
PRIMARY outcome
Timeframe: 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.
Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)
Outcome measures
| Measure |
Trazodone
n=7 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=8 Participants
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.
|
|---|---|---|
|
Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)
|
50.35 minutes
Standard Deviation 27.47
|
-7.56 minutes
Standard Deviation 38.04
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Trazodone
n=7 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=8 Participants
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.
|
|---|---|---|
|
Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months
|
-12.29 score on a scale
Standard Deviation 4.35
|
-10.75 score on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Trazodone
n=7 Participants
Trazodone: 50 mg once a day, for 3 months
|
Cognitive Behavioral Therapy
n=8 Participants
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.
|
|---|---|---|
|
Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months
|
-13.29 score on a scale
Standard Deviation 3.77
|
-10.38 score on a scale
Standard Deviation 3.02
|
Adverse Events
Trazodone
Cognitive Behavioral Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexandros Vgontzas
Penn State University College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place