Implementing Sleep Interventions for Older Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00781963
First received: October 28, 2008
Last updated: June 10, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


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 ]

Enrollment: 159
Study Start Date: May 2010
Study Completion Date: December 2013
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781963

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

Publications:
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: June 10, 2014
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 July 24, 2014