Implementing Sleep Interventions for Older Veterans
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|ClinicalTrials.gov Identifier: NCT00781963|
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : October 2, 2014
Last Update Posted : April 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: CBTI Behavioral: Sleep education||Not Applicable|
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:Individual Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI, or group-based Sleep Education Control Condition (Control). The intervention involves a manual-based behavioral sleep intervention provided by health educators. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Implementing Sleep Interventions for Older Veterans|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Individual CBTI
Manual-based CBTI provided in 5 individual sessions by health educator.
Experimental: Group CBTI
Manual-based CBTI provided in 5 group sessions by health educator.
Sleep education control condition provided in 5 group sessions by health educator.
Behavioral: Sleep education
- Sleep Efficiency [ Time Frame: Six months after baseline assessment ]Calculated from 7-day sleep diary
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Six months after baseline assessment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781963
|United States, California|
|VA Greater Los Angeles Healthcare System, Sepulveda, CA|
|Sepulveda, California, United States, 91343|
|Principal Investigator:||Cathy A. Alessi, MD||VA Greater Los Angeles Healthcare System, Sepulveda, CA|