Full Text View
Tabular View
No Study Results Posted
Related Studies
Implementing Sleep Interventions for Older Veterans
This study is not yet open for participant recruitment.
Verified by Department of Veterans Affairs, April 2009
First Received: October 28, 2008   Last Updated: April 2, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00781963
  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.


Condition Intervention
Insomnia
Behavioral: Individual-behavioral sleep intervention
Behavioral: Group-based Cognitive Behavioral Therapy for Insomnia
Behavioral: Social attention/stress management and wellness education program

MedlinePlus related topics: Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Implementing Sleep Interventions for Older Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

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
1: Experimental
Individual-Behavioral Sleep Intervention
Behavioral: Individual-behavioral sleep intervention
A manual-based behavioral sleep intervention based on CBT for insomnia, provided by allied health personnel.
2: Experimental
Group-based Cognitive Behavioral Therapy for Insomnia
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
3: Placebo Comparator
Social attention/stress management and wellness education program
Behavioral: Social attention/stress management and wellness education program
This placebo comparator arm will combine social attention, stress management and a wellness education program

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 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Report symptoms that meet diagnostic criteria for insomnia and are:

  1. age >=65,
  2. community-dwelling,
  3. live within a 30-mile radius of VA GLAHS, and
  4. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781963

Contacts
Contact: Karen Josephson, MPH (818) 895-9311 karen.josephson@va.gov

Locations
United States, California
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, United States, 91343
Sponsors and Collaborators
Investigators
Principal Investigator: Cathy A. Alessi, MD VA Greater Los Angeles HCS, Sepulveda
  More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:
cognitive behavior therapy
insomnia

ClinicalTrials.gov processed this record on May 07, 2009