Trial Outcomes & Findings for Insomnia Treatment for Women Veterans (NCT NCT02076165)
NCT ID: NCT02076165
Last Updated: 2019-06-11
Results Overview
Number of participants who attended and completed all 5 behavioral treatment sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
347 participants
Primary outcome timeframe
End of the 5-week behavioral treatment period
Results posted on
2019-06-11
Participant Flow
347 subjects were enrolled into the study (i.e., signed consent) and were administered the baseline assessment. Final eligibility determination was made after baseline assessments. Only participants who met final inclusion/exclusion criteria (after baseline) were eligible for randomization. Results are only provided for the 149 randomized subjects.
Participant milestones
| Measure |
ABC-I
Experimental: ABC-I Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
Active Comparator: CBT-I Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
66
|
69
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
ABC-I
Experimental: ABC-I Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
Active Comparator: CBT-I Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Refused follow-up assessment
|
1
|
1
|
Baseline Characteristics
Insomnia Treatment for Women Veterans
Baseline characteristics by cohort
| Measure |
ABC-I
n=74 Participants
Participants will participate in 5 individual sessions with a trained instructor.
Behavioral treatment for insomnia-Group I: Participants will attend 5 individual sessions with a trained instructor.
|
CBT-I
n=75 Participants
Participants will participate in 5 individual sessions with a trained instructor.
Behavioral treatment for insomnia-Group II: Participants will attend in 5 individual sessions with a trained instructor.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.89 years
STANDARD_DEVIATION 12.68 • n=93 Participants
|
47.76 years
STANDARD_DEVIATION 13.53 • n=4 Participants
|
47.82 years
STANDARD_DEVIATION 13.07 • n=27 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Insomnia Severity Index (ISI)
|
14.19 units on a scale
STANDARD_DEVIATION 4.82 • n=93 Participants
|
14.57 units on a scale
STANDARD_DEVIATION 5.12 • n=4 Participants
|
14.38 units on a scale
STANDARD_DEVIATION 4.96 • n=27 Participants
|
|
Patient Health Questionnaire-9 (PHQ-9)
|
10.55 units on a scale
STANDARD_DEVIATION 5.67 • n=93 Participants
|
10.28 units on a scale
STANDARD_DEVIATION 5.42 • n=4 Participants
|
10.42 units on a scale
STANDARD_DEVIATION 5.53 • n=27 Participants
|
|
PTSD Checklist for DSM-5
|
26.25 units on a scale
STANDARD_DEVIATION 21.81 • n=93 Participants
|
25.28 units on a scale
STANDARD_DEVIATION 20.97 • n=4 Participants
|
25.75 units on a scale
STANDARD_DEVIATION 21.32 • n=27 Participants
|
PRIMARY outcome
Timeframe: End of the 5-week behavioral treatment periodNumber of participants who attended and completed all 5 behavioral treatment sessions.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Number of Participants Completing 5 Behavioral Treatment Sessions
|
63 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: Final 7 nights of the 5-week intervention periodMinutes deviation from recommended bedtime recommendations during final week of intervention period.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Adherence With Bedtime Recommendations
|
-6.43 minutes
Standard Error 2.59
|
-5.71 minutes
Standard Error 2.48
|
PRIMARY outcome
Timeframe: Final 7-nights of the 5-week intervention periodMinutes deviation from recommended rise time during the final week of the intervention period
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Adherence to Rise Time Recommendations
|
20.63 minutes
Standard Error 3.73
|
23.41 minutes
Standard Error 3.58
|
PRIMARY outcome
Timeframe: Final 7-nights of the 5-week intervention periodAverage proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Non-adherence to Nighttime Stimulus Control
|
.274 Proportion of nights
Standard Error .035
|
.273 Proportion of nights
Standard Error .033
|
SECONDARY outcome
Timeframe: 1 week after the end of the 5-week intervention periodSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Sleep Efficiency From Sleep Diary at Post-Treatment
|
13.88 percentage of time asleep
Standard Error 1.45
|
13.47 percentage of time asleep
Standard Error 1.41
|
SECONDARY outcome
Timeframe: 3-months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Sleep Efficiency From Sleep Diary at 3-month Follow-up
|
12.74 percentage of time asleep
Standard Error 1.52
|
11.98 percentage of time asleep
Standard Error 1.47
|
SECONDARY outcome
Timeframe: 1 week after the end of the 5-week intervention periodSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Sleep Efficiency From Actigraphy at Post-Treatment
|
2.32 percentage of time asleep
Standard Error 0.83
|
1.64 percentage of time asleep
Standard Error 0.79
|
SECONDARY outcome
Timeframe: 3-months after randomizationSleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up
|
1.33 percentage of time asleep
Standard Error 0.99
|
0.22 percentage of time asleep
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline and 1 week after the end of the 5-week intervention periodMean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Change From Baseline to Post-Treatment in Insomnia Severity Index Score
|
-8.68 score on a scale
Standard Error 0.65
|
-9.18 score on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline and 3-months from randomizationMean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Outcome measures
| Measure |
ABC-I
n=74 Participants
Participants completed a 5 session intervention, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I). This was considered the "new treatment" being studied.
|
CBT-I
n=75 Participants
Participants received a 5-session intervention, cognitive-behavioral therapy for insomnia (CBT-I). This was considered the "standard care" treatment.
|
|---|---|---|
|
Change From Baseline to 3-month Follow-up in Insomnia Severity Index Score
|
-8.29 score on a scale
Standard Error 0.76
|
-7.71 score on a scale
Standard Error 0.74
|
Adverse Events
ABC-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CBT-I
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
Dr. Jennifer Martin
VA Greater Los Angeles Healthcare System
Phone: 818 891-7711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place