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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00781963 |
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 65 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:
1) Individual-Behavioral Sleep Intervention (Individual-BSI), 2) Group-based Cognitive Behavioral Therapy for Insomnia (Group CBT-I), or 3) an active control condition (social attention/stress management and wellness education program). Both active treatment conditions will be given using a written manual based on CBT for insomnia, and will be provided by allied health personnel. Data collected will include several measures of sleep, depression and quality of life. These measures 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 compared to control participants, intervention participants will have improvements in sleep and will report less depressive symptoms and better quality of life at six months follow-up. We also expect that these improvements will be maintained at 12-months follow-up.
Condition | Intervention |
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Insomnia |
Behavioral: Individual-behavioral sleep intervention Behavioral: Group-based Cognitive Behavioral Therapy for Insomnia Behavioral: Social attention/stress management and wellness education program |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Implementing Sleep Interventions for Older Veterans |
Estimated Enrollment: | 150 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Individual-Behavioral Sleep Intervention
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Behavioral: Individual-behavioral sleep intervention
A manual-based behavioral sleep intervention based on CBT for insomnia, provided by allied health personnel.
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2: Experimental
Group-based Cognitive Behavioral Therapy for Insomnia
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Behavioral: Group-based Cognitive Behavioral Therapy for Insomnia
A manual-based behavioral sleep intervention based on CBT for insomnia, provided by allied health personnel in group-based sessions
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3: Placebo Comparator
Social attention/stress management and wellness education program
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Behavioral: Social attention/stress management and wellness education program
This placebo comparator arm will combine social attention, stress management and a wellness education program
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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 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 65 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: 1) Individual-Behavioral Sleep Intervention (Individual-BSI), 2) Group-based Cognitive Behavioral Therapy for Insomnia (Group CBT-I), or 3) an active control condition (social attention/stress management and wellness education program). Both active treatment conditions involve a manual-based behavioral sleep intervention based on CBT for insomnia, 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 or control conditions, 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 compared to control participants, intervention participants will have improvements in sleep (both objectively and subjectively) and will report less depressive symptoms and better quality of life at six months follow-up. We also expect that these improvements will be maintained at 12-months follow-up.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Report symptoms that meet diagnostic criteria for insomnia and are:
Exclusion Criteria:
Contact: Karen Josephson, MPH | (818) 895-9311 | karen.josephson@va.gov |
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 |
Responsible Party: | Department of Veterans Affairs ( Alessi, Cathy - Principal Investigator ) |
Study ID Numbers: | IIR 08-295 |
Study First Received: | October 28, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00781963 History of Changes |
Health Authority: | United States: Federal Government |
cognitive behavior therapy insomnia |