Insomnia Clinical Trial
Official title:
Treating Sleep Problems in VA Adult Day Health Care
The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans. Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services. Veterans in ADHC commonly suffer from limited poor functioning, depression, cognitive problems and low quality of life. These factors can lead to continued deterioration in functioning, loss of independence, hospitalizations, nursing home placement and death. Sleep disruption is associated with depression, low quality of life, functional decline, nursing home placement, and death among older people. Sleep disturbance is common among ADHC patients, it is not addressed within routine clinical care, and treatment may be limited to medications. Studies show that untreated insomnia and medications for insomnia can increase risk of falls and other health events among older persons. On the other hand, non-medication treatments for sleep do not show these problems. These treatments have been shown to be effective in other studies. The goal of this study is to test non-medication treatments to improve sleep among older Veterans with insomnia in a VA ADHC program. The study design will facilitate translation into routine care and application in other similar VA programs.
The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the
Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans.
Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services.
ADHC provides health maintenance, rehabilitation services and socialization in a group
setting during daytime hours. Veterans in ADHC commonly suffer from limited physical
functioning, depression, cognitive difficulties and low quality of life. These factors
increase the likelihood of continued deterioration in functioning, loss of independence,
hospitalizations, nursing home placement and death. Previous studies, including our own
work, have demonstrated that sleep disruption is associated with depression, low quality of
life, functional decline, nursing home placement, and death among older people. The
investigators have found that sleep disturbance is common among ADHC patients, it is not
addressed within routine clinical care, and treatment is commonly limited to medications
(e.g., hypnotics, sedating antidepressants). Numerous studies show that both untreated
insomnia and pharmacological treatment of insomnia can be associated with increased risk of
falls and other adverse health events among older persons. On the other hand,
nonpharmacological interventions on sleep do not show these adverse effects, have been shown
to be effective and are associated with improvements in mood, quality of life and health.
The goal of the study was to test the effectiveness of a cognitive-behavioral intervention
to improve self-reported and objectively-measured sleep quality among older veterans with
insomnia in a VA ADHC program. The intervention program involved a 4-session manualized
treatment. This Sleep Intervention Program (SIP) was compared to an active Sleep Education
control that also included 4 individual sessions using a randomized trial with 72 veterans.
To our knowledge, this study is the first to address the unmet need for non-pharmacological
treatment of sleep problems among ADHC patients. The intervention design (e.g., use of a
manualized treatment that can be provided by non-psychologists) will facilitate translation
into routine care and application in other similar VA programs.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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