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Implementing Sleep Interventions for Older Veterans - NCT00781963-91343(Clinical Trial 249889)



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City:  Sepulveda
State:  
CA
Zip Code: 91343
Conditions: Insomnia
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 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.
Study summary: 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.
Criteria: Inclusion Criteria: Report symptoms that meet diagnostic criteria for insomnia and are: - age >=65, - 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).
Study is available at: VA Greater Los Angeles HCS, Sepulveda
Sepulveda, CA 91343
United States

Primary Contact:
Cathy A Alessi, MD
Email: cathy.alessi@va.gov
Phone: 818-891-7711

Secondary Contact:
Terry Z Vandenberg, MA
Email: terry.vandenberg@va.gov
Phone: (818) 891-7711
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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