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Implementing Sleep Interventions for Older Veterans

Implementing Sleep Interventions for Older Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00781963
Enrollment
519
Registered
2008-10-29
Start date
2010-05-31
Completion date
2013-12-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

cognitive behavior therapy, insomnia

Brief summary

Sleep problems are common among older people, and research suggests that insomnia has negative effects on health and quality of life in older adults. Prior research suggests that insomnia symptoms are even more common among veterans compared to the general population. In addition, people with sleep problems also often have depression and other problems that seem to decrease their quality of life. In this study, we tested two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work was to identify ways to improve access to these types of behavioral sleep interventions for older veterans, in order to improve their well-being and quality of life. This project was conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia were identified by a postal survey. Enrolled veterans with insomnia (N=150 total, 50 per group) were randomized to one of three groups: Individual-Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI or a group-based Sleep Education Control Condition (Control). Measures of sleep, depression and quality of life were performed at baseline (enrollment in the study), after the treatment was completed, and at 6-months and 12-months follow-up after randomization. Main outcome measures included sleep/wake patterns (sleep questionnaires, sleep diary and wrist actigraphy, which is an objective estimate of sleep and wakefulness). We hypothesized that the intervention would improve sleep at six months follow-up. We also expected that these improvements would be maintained at 12-months follow-up.

Detailed description

Sleep disturbance is common among older people due to age-related changes in sleep, in addition to health conditions, psychosocial issues, medication effects and a variety of other factors that impact sleep. The evidence that insomnia has negative effects on health and quality of life in older adults is convincing. Prior research has demonstrated that insomnia symptoms are even more common among veterans compared to the general population. Our own work has demonstrated that sleep problems are associated with depressive symptoms and other impairments in quality of life in older people, and that nonpharmacological and behavioral interventions can improve sleep in a variety of settings. Objectives: We tested two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work was to identify ways to improve access to behavioral sleep interventions for older veterans, in order to improve their well-being and quality of life. Methods: This project was conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia were identified by a postal survey. Enrolled veterans with insomnia (N=150, 50 per group) were randomized to one of three groups:Individual Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI, or group-based Sleep Education Control Condition (Control). The intervention involved a manual-based behavioral sleep intervention provided by a non-clinician sleep coach. Baseline data included subjective and objective measures of sleep, and structured assessments of depression and quality of life. Post-treatment assessments was performed after completion of the 6-week intervention, and follow-up assessments were performed at 6-months and 12-months after randomization. Main outcome measures were: sleep measures obtained from sleep diaries (i.e., sleep onset latency, wake after sleep onset, total wake time, sleep efficiency). Sleep efficiency was also obtained from wrist actigraphy. Subjective sleep quality was measured by the Pittsburgh Sleep Quality Index. Insomnia severity, depression and self-reported quality of life were measured as secondary outcomes. Data were analyzed for all randomized participants (n=159) in an intention to treat analysis. The study was not designed to compare differences in primary outcomes between individual and group CBT-I. Subjects who received individual and group CBT-I were pooled to form the intervention group. We hypothesized that the intervention would improve sleep (both objectively and subjectively) at six-month follow-up and improvements would be maintained at 12-month follow-up.

Interventions

BEHAVIORALManual-based cognitive behavioral therapy for insomnia

Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.

BEHAVIORALNon-directive sleep education

Manual-based non-directive sleep education provided in 5 group sessions by a health educator.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Report symptoms that meet diagnostic criteria for insomnia and are: * age \>=60, * community-dwelling, * live within a 30-mile radius of VA Greater Los Angeles Healthcare System (GLAHS), and * have transportation to VA GLAHS to attend the intervention/control programs.

Exclusion criteria

* Significant cognitive impairment (MMSE score \<24) and have evidence of sleep apnea (by questionnaire and/or sleep monitoring).

Design outcomes

Primary

MeasureTime frameDescription
Sleep Onset LatencySix months after randomizationMean time to fall asleep based on 7-day sleep diary.
Wake After Sleep OnsetSix months after randomizationMean total minutes awake during nighttime awakenings based on 7-day sleep diary.
Total Wake TimeSix months after randomizationMean total minutes awake from bedtime to rise time based on 7-day sleep diary.
Sleep Efficiency From Sleep DiarySix months after randomizationSleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.
Sleep Efficiency From Wrist ActigraphySix months from randomizationSleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.
Pittsburgh Sleep Quality Index (PSQI)Six months after randomizationThe 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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).

Participants by arm

ArmCount
CBT-I
Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator.
106
Control
Non-directive sleep education provided in 5 group sessions by a health educator.
53
Total159

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath30
Overall StudyLost to Follow-up21
Overall StudyRefused follow-up90
Overall StudyWithdrawal by Subject31

Baseline characteristics

CharacteristicTotalCBT-IControl
Age, Continuous72.2 years
STANDARD_DEVIATION 7.7
71.2 years
STANDARD_DEVIATION 7.9
72.4 years
STANDARD_DEVIATION 7.3
Sex: Female, Male
Female
6 Participants5 Participants1 Participants
Sex: Female, Male
Male
153 Participants101 Participants52 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1060 / 53
other
Total, other adverse events
0 / 1060 / 53
serious
Total, serious adverse events
0 / 1060 / 53

Outcome results

Primary

Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame: Six months after randomization

ArmMeasureValue (MEAN)
CBT-IPittsburgh Sleep Quality Index (PSQI)6.0 units on a scale
ControlPittsburgh Sleep Quality Index (PSQI)7.2 units on a scale
p-value: <0.00195% CI: [-3.5, -1.3]Mixed Models Analysis
Primary

Sleep Efficiency From Sleep Diary

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

Time frame: Six months after randomization

ArmMeasureValue (MEAN)
CBT-ISleep Efficiency From Sleep Diary82.7 percentage of time asleep while in bed
ControlSleep Efficiency From Sleep Diary83.1 percentage of time asleep while in bed
p-value: 0.00595% CI: [2, 11.3]Mixed Models Analysis
Primary

Sleep Efficiency From Wrist Actigraphy

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

Time frame: Six months from randomization

ArmMeasureValue (MEAN)
CBT-ISleep Efficiency From Wrist Actigraphy82.7 percentage of time asleep while in bed
ControlSleep Efficiency From Wrist Actigraphy83.1 percentage of time asleep while in bed
p-value: 0.1595% CI: [-3.3, 0.5]Mixed Models Analysis
Primary

Sleep Onset Latency

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

Time frame: Six months after randomization

ArmMeasureValue (MEAN)
CBT-ISleep Onset Latency21.3 Minutes
ControlSleep Onset Latency31.3 Minutes
p-value: <0.00195% CI: [-28.7, -3]Mixed Models Analysis
Primary

Total Wake Time

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

Time frame: Six months after randomization

ArmMeasureValue (MEAN)
CBT-ITotal Wake Time73.4 Minutes
ControlTotal Wake Time108 Minutes
p-value: 0.00495% CI: [-62.2, -11.7]Mixed Models Analysis
Primary

Wake After Sleep Onset

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

Time frame: Six months after randomization

ArmMeasureValue (MEAN)
CBT-IWake After Sleep Onset30.3 Minutes
ControlWake After Sleep Onset42.8 Minutes
p-value: 0.2195% CI: [-26.3, 5.9]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026