Insomnia, Sleep Disorders
Conditions
Keywords
Sleep, Rehabilitation, Behavior therapy, Insomnia
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSleep Intervention Program
Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia.
BEHAVIORALSleep Education control
During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the following: * ADHC program participant * Age \>= 60 years * Ability to communicate verbally
Exclusion criteria
One or more of the following: * Significant cognitive impairment (Mini Mental State Examination score\<20)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | End of 4-week intervention | Percentage of time asleep while in bed estimated by actigraphy |
Countries
United States
Participant flow
Recruitment details
Veterans enrolled in the ADHC program for at least one month were screened for study eligibility criteria (i.e., the ability to understand screening items and to communicate during the screening process. If the individual was interested, written informed consent was obtained.
Pre-assignment details
A total of 72 participants were enrolled into the study. After baseline assessment, 30 participants were not eligible for randomization: too cognitive impaired to participate (13); medical or behavioral issue (n=6); no longer met criteria for insomnia (n=3); discharged from ADHC (n=4); refused randomization (n=2); withdrew (n=2).
Participants by arm
| Arm | Count |
|---|---|
| SIP Group The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.
Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia. | 21 |
| Control Group The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care
Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 4-month Follow-up | Death | 0 | 1 |
| 4-month Follow-up | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | SIP Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 77.7 years STANDARD_DEVIATION 10.2 | 76.4 years STANDARD_DEVIATION 9.9 | 77.1 years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized Non-white | 8 participants | 4 participants | 12 participants |
| Race/Ethnicity, Customized White | 13 participants | 17 participants | 30 participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 18 Participants | 21 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Sleep Efficiency
Percentage of time asleep while in bed estimated by actigraphy
Time frame: End of 4-week intervention
Population: Two SIP subjects had missing data for this variable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SIP Group | Sleep Efficiency | 86.6 percentage of time in bed spent asleep |
| Control Group | Sleep Efficiency | 83.3 percentage of time in bed spent asleep |
p-value: 0.04ANCOVA
Primary
Sleep Efficiency
Percentage of time asleep while in bed estimated by actigraphy.
Time frame: 4-month follow-up
Population: Two SIP subjects had missing data for this variable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SIP Group | Sleep Efficiency | 85.3 percentage of time in bed asleep |
| Control Group | Sleep Efficiency | 81.5 percentage of time in bed asleep |
p-value: 0.061ANCOVA