Implementing Sleep Interventions for Older Veterans
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Purpose
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 will test two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work is 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 will be conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia will be identified by a postal survey. Enrolled veterans with insomnia (N=150 total, 50 per group) will be randomized to one of three groups: an Individual-Behavioral Sleep Intervention (Individual-BSI), or one of two group-based interventions. Measures of sleep, depression and quality of life will be performed at baseline (enrollment in the study), after the treatment is completed, and during assessments at 6-months and 12-months follow-up. Main outcome measures will include sleep/wake patterns (sleep questionnaires and wrist actigraphy, which is an objective estimate of sleep and wakefulness), depression and self-reported quality of life. We hypothesize that the intervention will improve sleep and will improve depressive symptoms and quality of life at six months follow-up. We also expect that these improvements will be maintained at 12-months follow-up.
| Condition | Intervention |
|---|---|
|
Insomnia |
Behavioral: Individual-behavioral sleep intervention Behavioral: Group-based behavioral sleep intervention I Behavioral: Group-based behavioral sleep intervention II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Implementing Sleep Interventions for Older Veterans |
- Sleep/wake patterns (sleep questionnaires and wrist actigraphy), depression and self-reported quality of life [ Time Frame: Six months after baseline assessment ] [ Designated as safety issue: No ]
| Enrollment: | 159 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Individual-Behavioral Sleep Intervention
|
Behavioral: Individual-behavioral sleep intervention
A manual-based behavioral sleep intervention provided by allied health personnel in individual sessions.
|
|
Experimental: Arm 2
Group-based Behavioral Sleep Intervention I
|
Behavioral: Group-based behavioral sleep intervention I
A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions
|
|
Experimental: Arm 3
Group-based Behavioral Sleep Intervention II
|
Behavioral: Group-based behavioral sleep intervention II
A manual-based behavioral sleep intervention provided by allied health personnel in group-based sessions
|
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 propose to test two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work is 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 will be conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia will be identified by a postal survey. Enrolled veterans with insomnia (N=150, 50 per group) will be randomized to one of three groups: an Individual-Behavioral Sleep Intervention (Individual-BSI), or one of two group-based interventions. The intervention involves a manual-based behavioral sleep intervention provided by allied health personnel. Baseline data will include subjective and objective measures of sleep, and structured assessments of depression and quality of life. Post-treatment assessments will be performed after completion of the 6-week intervention, and follow-up assessments will be performed at 6-months and 12-months follow-up. Main outcome measures will include sleep/wake patterns (sleep questionnaires and wrist actigraphy), depression and self-reported quality of life. Data will be analyzed for all randomized participants in an intention to treat analysis. We hypothesize that the intervention will improve sleep (both objectively and subjectively) and will improve depressive symptoms and quality of life at six months follow-up. We also expect that these improvements will be maintained at 12-months follow-up.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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 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).
Contacts and Locations| United States, California | |
| VA Greater Los Angeles HCS, Sepulveda | |
| Sepulveda, California, United States, 91343 | |
| Principal Investigator: | Cathy A. Alessi, MD | VA Greater Los Angeles HCS, Sepulveda |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00781963 History of Changes |
| Other Study ID Numbers: | IIR 08-295 |
| Study First Received: | October 28, 2008 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
cognitive behavior therapy insomnia |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013