Trial Outcomes & Findings for Implementing Sleep Interventions for Older Veterans (NCT NCT00781963)

Results Overview

Mean time to fall asleep based on 7-day sleep diary.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

519 participants

Primary outcome timeframe

Six months after randomization

Results posted on

2019-04-17

Participant Flow

Participants were recruited from among community-dwelling older veterans who responded to an insomnia screening postal survey and who met diagnostic criteria for insomnia. The recruitment period was from May 2010 to February 2012. A total of 519 subjects were enrolled.

Following enrollment, subjects with a Mini-Mental State Exam (MMSE) score \< 24 or an apnea hypopnea index (AHI) \> 20 were ineligible for randomization. Subjects with unstable medical or psychological conditions were also excluded. Results are presented for the 159 subjects who were randomized (106 intervention and 53 control).

Participant milestones

Participant milestones
Measure	CBT-I Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator	Control Non-directive sleep education provided in 5 group sessions by a health educator.
Overall Study STARTED	106	53
Overall Study COMPLETED	89	51
Overall Study NOT COMPLETED	17	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CBT-I Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator	Control Non-directive sleep education provided in 5 group sessions by a health educator.
Overall Study Death	3	0
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	3	1
Overall Study Refused follow-up	9	0

Baseline Characteristics

Implementing Sleep Interventions for Older Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.	Total n=159 Participants Total of all reporting groups
Age, Continuous	71.2 years STANDARD_DEVIATION 7.9 • n=39 Participants	72.4 years STANDARD_DEVIATION 7.3 • n=41 Participants	72.2 years STANDARD_DEVIATION 7.7 • n=35 Participants
Sex: Female, Male Female	5 Participants n=39 Participants	1 Participants n=41 Participants	6 Participants n=35 Participants
Sex: Female, Male Male	101 Participants n=39 Participants	52 Participants n=41 Participants	153 Participants n=35 Participants

PRIMARY outcome

Timeframe: Six months after randomization

Mean time to fall asleep based on 7-day sleep diary.

Outcome measures

Outcome measures
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.
Sleep Onset Latency	21.3 Minutes Interval 16.8 to 25.8	31.3 Minutes Interval 25.4 to 37.2

PRIMARY outcome

Timeframe: Six months after randomization

Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.

Outcome measures

Outcome measures
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.
Wake After Sleep Onset	30.3 Minutes Interval 22.9 to 37.7	42.8 Minutes Interval 33.0 to 52.7

PRIMARY outcome

Timeframe: Six months after randomization

Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.

Outcome measures

Outcome measures
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.
Total Wake Time	73.4 Minutes Interval 61.4 to 85.4	108 Minutes Interval 91.8 to 124.1

PRIMARY outcome

Timeframe: Six months after randomization

Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.

Outcome measures

Outcome measures
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.
Sleep Efficiency From Sleep Diary	82.7 percentage of time asleep while in bed Interval 81.3 to 84.1	83.1 percentage of time asleep while in bed Interval 81.2 to 85.0

PRIMARY outcome

Timeframe: Six months from randomization

Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.

Outcome measures

Outcome measures
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.
Sleep Efficiency From Wrist Actigraphy	82.7 percentage of time asleep while in bed Interval 81.3 to 84.1	83.1 percentage of time asleep while in bed Interval 81.2 to 85.0

PRIMARY outcome

Timeframe: Six months after randomization

The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 - 21. A total score \> 8 indicates poor sleep quality.

Outcome measures

Outcome measures
Measure	CBT-I n=106 Participants Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Control n=53 Participants Non-directive sleep education provided in 5 group sessions by a health educator.
Pittsburgh Sleep Quality Index (PSQI)	6.0 units on a scale Interval 5.3 to 6.7	7.2 units on a scale Interval 6.2 to 8.2

Adverse Events

CBT-I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Control

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. Cathy Alessi

VA Greater Los Angeles Healthcare System

Phone: 818 895-9311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place