Implementing Sleep Interventions for Older Veterans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementing Sleep Interventions for Older Veterans

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Manual-based cognitive behavioral therapy for insomnia
* Behavioral: Non-directive sleep education


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I<br>Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach. | Behavioral: Manual-based cognitive behavioral therapy for insomnia<br>* Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.<br>|
| Active Comparator: Control<br>Non-directive sleep education provided in 5 group sessions by a health educator. | Behavioral: Non-directive sleep education<br>* Manual-based non-directive sleep education provided in 5 group sessions by a health educator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Onset Latency | Mean time to fall asleep based on 7-day sleep diary. | Six months after randomization | 
| Wake After Sleep Onset | Mean total minutes awake during nighttime awakenings based on 7-day sleep diary. | Six months after randomization | 
| Total Wake Time | Mean total minutes awake from bedtime to rise time based on 7-day sleep diary. | Six months after randomization | 
| Sleep Efficiency From Sleep Diary | Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary. | Six months after randomization | 
| Sleep Efficiency From Wrist Actigraphy | Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy. | Six months from randomization | 
| 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. | Six months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavior therapy, insomnia