Trial Outcomes & Findings for Sequenced Therapies for Comorbid and Primary Insomnias (NCT NCT01651442)
NCT ID: NCT01651442
Last Updated: 2021-03-29
Results Overview
The Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months
Results posted on
2021-03-29
Participant Flow
Participant milestones
| Measure |
Non-drug Sleep Therapy 1
Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
|
Sleep Medication 1
Zolpidem: 5mg or 10mg
|
Non-drug Sleep Therapy 2 Following Non-drug Sleep Therapy 1
Cognitive Therapy: Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions.
|
Sleep Medication 2 Following Sleep Medication 1
Trazodone: 50mg to 150mg
|
Non-drug Sleep Therapy 1 Following Sleep Medication 1
Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
|
Sleep Medication 1 Following Non-drug Sleep Therapy 1
Zolpidem: 5mg or 10mg
|
|---|---|---|---|---|---|---|
|
Phase I Treatment
STARTED
|
104
|
107
|
0
|
0
|
0
|
0
|
|
Phase I Treatment
COMPLETED
|
88
|
80
|
0
|
0
|
0
|
0
|
|
Phase I Treatment
NOT COMPLETED
|
16
|
27
|
0
|
0
|
0
|
0
|
|
Phase II Treatment
STARTED
|
0
|
0
|
27
|
27
|
27
|
27
|
|
Phase II Treatment
COMPLETED
|
0
|
0
|
25
|
15
|
21
|
17
|
|
Phase II Treatment
NOT COMPLETED
|
0
|
0
|
2
|
12
|
6
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sequenced Therapies for Comorbid and Primary Insomnias
Baseline characteristics by cohort
| Measure |
Non-drug Sleep Therapy 1
n=104 Participants
Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
|
Sleep Medication 1
n=107 Participants
Zolpidem: 5mg or 10mg
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 14.4 • n=93 Participants
|
45.4 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
45.6 years
STANDARD_DEVIATION 14.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
132 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
94 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
187 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 monthsThe Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8.
Outcome measures
| Measure |
Non-drug Sleep Therapy 1
n=90 Participants
Behavioral Insomnia Therapy: Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
|
Sleep Medication 1
n=83 Participants
Zolpidem: 5mg or 10mg
|
Sleep Medication 1 Plus Non-drug Sleep Therapy 1
n=27 Participants
Zolpidem Plus Behavioral Therapy
|
Sleep Medication 1 Plus Sleep Medication 2
n=27 Participants
Zolpidem Plus Trazodone
|
Non-drug Sleep Therapy 1 Plus Non-drug Sleep Therapy 1
n=27 Participants
Behavioral Therapy Plus Cognitive Therapy
|
Non-drug Sleep Therapy 1 Plus Sleep Medication 1
n=27 Participants
Behavioral Therapy Plus Zolpidem
|
|---|---|---|---|---|---|---|
|
Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index
|
40.00 percent remitted
|
34.94 percent remitted
|
37.04 percent remitted
|
48.15 percent remitted
|
44.44 percent remitted
|
55.56 percent remitted
|
Adverse Events
Non-drug Sleep Therapy 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Medication 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-drug Sleep Therapy 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Medication 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place