Effects of cranial electrical stimulation on sleep disturbances, depressive symptoms, and caregiving appraisal in spousal caregivers of persons with alzheimer's disease
Applied Nursing Research 22 (2009) 119 – 125
Effects of cranial electrical stimulation on sleep disturbances,
depressive symptoms, and caregiving appraisal in spousal
caregivers of persons with Alzheimer's disease☆
Karen M. Rose, PhDa,⁎, Ann Gill Taylor, MS, EdDa,b, Cheryl Bourguignon, PhDa,b
aSchool of Nursing, University of Virginia, Charlottesville, VA 22908-0782, USA
bCenter for the Study of Complementary and Alternative Therapies, The Blake Center, Charlottesville, VA 22908-0905, USA
Received 26 February 2007; revised 7 June 2007; accepted 7 June 2007
Purpose: The purpose of this work was to investigate the effects of cranial electrical stimulation(CES) on sleep disturbances, depressive symptoms, and caregiving appraisal.
Methods: Thirty-eight participants were randomly assigned to receive active CES or sham CES for4 weeks.
Results: Both intervention groups demonstrated improvement in study measures from baselinescores. A trend toward statistically significant differences in daily sleep disturbances was foundbetween the groups. No differences in depressive symptoms and caregiving appraisal were foundbetween the groups.
Conclusions: These findings did not fully support the efficacy of the short-term use of active CESversus sham CES to improve sleep disturbances, depressive symptoms, or caregiving appraisal.
2009 Elsevier Inc. All rights reserved.
Sleep disturbances, depressive symptoms, and negative
appraisal of a caregiving situation pose threats to elderly
Family caregivers are the mainstay of caregiving support
caregivers of persons with AD in terms of the caregivers'
to persons with Alzheimer's disease (AD). More than 30% of
own physical and psychological well-being and their ability
caregivers for older people are, themselves, aged ≥ 65 years
to provide adequate care to the care recipient. Although
pharmacological therapies are most often used to relieve
physical and psychological consequences of providing care
sleep disturbances and depressive symptoms, these medica-
to a person with AD may be detrimental to the caregiver,
tions often have poorly tolerated side effects on older people.
particularly if the caregiver is elderly, has a negative
For many elderly persons, hypnotic medications prescribed
appraisal of one's caregiving situation, and is the spouse of
to relieve sleep disturbances may, in fact, pose serious threats
the care recipient. The negative health outcomes for
to their own safety and to the safety of those who are in their
caregivers, compared to those for noncaregiving persons
care. Thus, nonpharmacological interventions, such as
matched for age, include higher rates of sleep disturbances
cranial electrical stimulation (CES), may offer viable
and depressive symptoms, poorer self-ratings of overall
alternatives to ameliorating sleep disturbances and depres-
health status, and a 63% higher mortality rate (
sive symptoms in caregivers, while reducing the side effects
encountered with conventional pharmacological regimens.
CES involves the use of a small battery-operated device
that delivers low levels of alternating electrical current to the
☆ The contents of this work are solely the responsibility of the authors
head via clips attached to the earlobes (CES
and do not necessarily represent the official views of the National Center for
therapy has had positive effects on the treatment of sleep
Complementary and Alternative Medicine, National Institutes of Health.
disturbances, depressive symptoms, perceived stress, and
Corresponding author. Tel.: +1 434 924 5627; fax: +1 434 982 1809.
other disorders in a variety of patient populations, including
0897-1897/$ – see front matter 2009 Elsevier Inc. All rights reserved.
K.M. Rose et al. / Applied Nursing Research 22 (2009) 119–125
persons with fibromyalgia, depressive symptoms, anxiety,
The means and standard deviations from a study on the
effects of nonpharmacological intervention on sleep dis-
precise mechanism of action of CES in unknown, it is
turbances in elderly caregivers of persons with AD
believed that CES stimulates the vagus nerve, causing
parasympathetic response and resultant relaxation. Addi-
for the proposed study. Given the means and standard
tionally, increases in blood and cerebrospinal fluid levels of
deviations from the McCurry et al. study, a sample size of 38
specific neurotransmitters, including serotonin, norepine-
(19 per group) would yield 80% power to detect differences
phrine, dopamine, and β-endorphin, have been reported
between active and sham intervention groups over time in
when CES was used for both 1 and 2 weeks (Shealey et al.,
1998). However, no studies to date have specifically testedthe efficacy of CES in either an elderly population or a
caregiver population. Therefore, the purpose of this study
Participants were recruited from primary care providers
was to investigate the short-term use of the AlphaStim CES
and caregiver support groups in a rural setting in the
device in sleep disturbances, depressive symptoms, and
northeastern United States. Forty-four participants provided
subjective appraisal in elderly persons who are the primary
informed consent to participate in the study. Inclusion
caregivers for their spouses with AD.
criteria were as follows: (1) primary caregiver for a spouse
with AD or multi-infarct dementia in the home environment;(2) age of ≥ 60 years; (3) cognitive ability to complete
Psychoneuroimmunology (PNI) serves as the framework
questionnaires; (4) a Geriatric Depression Scale (GDS) score
for this study. PNI focuses on the influence of thoughts on
of ≥ 10 indicating the presence of depressive symptoms
behavior; on interactions between the central nervous
system, the endocrine system, and the immune system; and
AlphaStim device for 60 minutes/day in the course of
on the subsequent impact of these interrelationships on
4 weeks. Potential participants were excluded if they were
overall health. The PNI framework provides a model
using an antidepressant medication or a botanical agent with
depicting the potential influence of the negative appraisal
antidepressant properties (e.g., Ginkgo biloba, St. John's
of the stressor (caregiving) on the development of sleep
wort), or if they had an implantable device, such as a
disturbances and depressive symptoms, and how these
pacemaker or an internal defibrillator. After screening, 39 of
symptoms, in turn, may contribute to the development of
44 persons were found to be eligible based on the inclusion
other disease states stemming from neuroendocrine and
and exclusion criteria. Of the five individuals excluded from
participation, two persons were taking antidepressant
The concurrent development of depressive symptoms and
medications and three persons scored b10 on the GDS,
sleep disturbances is thought to occur as a result of the
indicating no depressive symptoms. Thirty-eight of the
dysregulation of the hypothalamic–pituitary–adrenalcorti-
39 eligible participants completed the trial (active CES
coid (HPA) and sympathetic–adrenal–medullary (SAM)
group, n = 19; sham CES group, n = 19). One person
axes in chronic stressful situations such as caregiving.
withdrew from the study after completing baseline measures,
Long-term activation of the HPA and SAM axes leads to
but prior to beginning CES intervention, due to health
dysregulation of neurotransmitters and neurotransmitter
concerns related to recent hospitalization.
receptors. The levels and functions of neurotransmitters
Participants' and care recipients' demographic data are
such as serotonin, norepinephrine, and dopamine have been
presented in . The intervention groups did not differ
shown to be affected by HPA and SAM axes dysregulation,
in any demographic variable except age (t = −2.081, p b
with resultant disturbances in sleep and mood.
.05), with the caregivers in the sham CES group being older(76.2 years; SD = 5.60) than those in the active CES group
(71.9 years; SD = 7.78). There was N95% adherence to thestudy protocol by participants in both intervention groups, as
documented by the participants' completion of a daily log ofCES use.
This study was a randomized, double-blind, controlled
pilot study that used repeated measures throughout the
4-week intervention. Study participants were randomlyassigned to one of two groups: active AlphaStim CES or
The CES device used in this study was the Alpha-Stim
sham CES. The study protocol was approved by the
Cranial Electrotherapy Stimulator device (Electromedical
Institutional Review Board at the University of Virginia.
Products International, Mineral Wells, TX). This battery-
Written informed consent was obtained from all participants.
operated device is relatively small and compact (3.9 in. long,
Power analysis was performed based on the variable of
3 in. wide, and 0.9 in. thick). A single cable attaches the
sleep disturbance as measured by the Pittsburgh Sleep
device to two ear clips worn by the participant. The device
Quality Index (PSQI) using nQuery power analysis software.
was preset at an electrical stimulation intensity of 100 μA; the
K.M. Rose et al. / Applied Nursing Research 22 (2009) 119–125
Table 1Demographic characteristics of the study sample
Length of time in caregiving role (months) [M (SD)]
Average hours of care provided by caregiver (weekly) [M (SD)]
Length of time of memory changes (months) [M (SD)]
Global Deterioration Scale score (cognitive decline)
timer was preset at 60 minutes; and the pulse rate was preset at
experienced by the caregivers during the past month. The
0.05 pulse/second, as recommended by the manufacturer.
component scores yield a global score in a range of 0–21
These preset parameters have been shown to attain the
points, where 0 = no difficulty and 21 = severe difficulties in
appropriate waveform configuration to achieve physiological
all areas. A cutoff score of ≥ 5 identifies persons with poor
changes in neurotransmitters. An electrical stimulation of
sleep. Test–retest reliability, as well as a sensitivity of 89.6%
100 μA is generally an imperceptible amount of electrical
and a specificity of 86.5%, has been established for this
current to most persons; this is important as this setting per-
scale. Scores on the PSQI were also analyzed with a three-
mitted the blinding of the study participants. The sham device
was identical in appearance to the active device, with the only
The General Sleep Disturbance Scale (GSDS) was used to
difference being that no electrical current was delivered.
measure caregivers' reports of sleep disturbances at baselineand at 2 and 4 weeks. The GSDS is a 21-item questionnaire
that rates aspects of sleep quality and quantity during the pastweek ). This instrument
The primary investigator gave both verbal and written
uses an 8-point frequency scale, with responses ranging from
instructions on the proper use of the AlphaStim CES device.
0 = never to 7 = every day. Higher scores indicate more sleep
Participants in both intervention groups (active and sham)
disturbances. A mean total GSDS score, or any mean on the
received a device at the time of randomization and were
three subscales (sleep quality, daytime function, and sleep
given a demonstration of the use of the device. Participants
medication), of ≥3 is equivalent to the Diagnostic and
also gave a return demonstration of the use of the AlphaStim
Statistical Manual of Mental Disorders, Fourth Edition
device to ensure that they understood its use. Participants
criteria for insomnia or sleeping difficulty. The GSDS has
were instructed to wear the CES device for 60 minutes/day
established internal consistency and reliability, with Cron-
for the 4-week intervention period and to complete a daily
bach's alpha values ranging from .80 to .88 (
log of CES usage. Study outcome measures were obtained at
Participants also responded to a set of sleep diary
questions pertaining to the previous night's sleep, including
the time the participant went to bed, the time taken to fallasleep (sleep onset latency; in minutes), the number of
nighttime awakenings, and the time the participant got out of
was used to measure self-reported sleep disturbances
K.M. Rose et al. / Applied Nursing Research 22 (2009) 119–125
Depressive symptoms in the study participants were
measured using the GDS at baseline and at 2 and
Mean scores on study outcomes between intervention groups at the end ofthe study (Week 4)
4 weeks. Total scores range from 0 to 30, with 0–9 = nodepressive symptoms; 10–19 = mild depressive symptoms;
and 20–30 = severe depressive symptoms (
). The Cronbach's alpha for the scale was reported
as .95, a with test–retest reliability of 0.85 (
Sleep onset latency (minutes; sleep diary) c 27.42
Caregiving appraisal in the study participants was
measured using the Philadelphia Geriatric Center Caregiving
designed to measure the impact of caring for disabled older
people by family caregivers, comprises 28 questions
b Trend toward statistical significance.
representing 4 subscales (burden, satisfaction, mastery, and
impact). The Cronbach's alpha for the entire scale wasreported as .92 in a sample of community-dwelling spousecaregivers of persons with dementia (
Test–retest reliability ranged between .75 and .78 in103 caregivers of institutionalized demented persons
There were no significant differences in overall scores on
For this study, the researcher analyzed each
sleep disturbances or sleep quality between the intervention
of the four subscales of the PGCCAS.
groups over time. A trend toward statistical significance (p =.09) in the daily disturbances subscale of the PSQI was found
between the intervention groups, with participants in the
The Statistical Package for the Social Sciences, version
active CES intervention group reporting a greater decrease in
12.0 (SPSS, Chicago, IL), was used to enter, clean, and
mean scores than those participants in the sham CES group.
verify the data. Because this research was an exploratory
No statistically significant results in sleep onset latency were
study, the level of significance was set at .05 for all tests, and
found between the two groups at baseline (p = .727) and at
4 weeks (p = .274), although clinically important differences
Descriptive statistics were calculated for all demographic
were found. The active CES group reported a 9-minute
and study variables. Differences in the demographic
decrease in sleep onset latency as compared to a 1-minute
characteristics of the intervention groups were compared
increase reported by participants in the sham CES group at
using chi-square analysis for categorical variables and using
independent t tests for continuous variables. Baseline
differences in study outcome measures of interest (scoreson the PSQI, GSDS, GDS, and PGCCAS) between the two
There were no significant differences in reports of
intervention groups were examined using independent
depressive symptoms between the intervention groups over
time (F = 9.022, p = .224). Participants in both intervention
Comparative analyses of the outcome variables of sleep
groups did show a decrease in reports of depressive
disturbances, depressive symptoms, and subjective appraisal
symptoms in the 4-week study period, with final depressive
in the 4-week trial period were conducted via one-way
scores in both groups falling below baseline scores.
analysis of covariance (ANCOVA) models for sleep
outcomes using the PSQI, or via repeated measuresANCOVA models for all other analyses. The between-
No significant differences in the appraisal of caregiving
subjects factor was treatment group, with two levels (active
situation were seen between the intervention groups over
CES and sham CES), and the within-subjects factor was
time, as indicated by scores on the four subscales of burden,
time, with two levels (Weeks 2 and 4). Baseline scores of
mastery, impact, or satisfaction with caregiving situation.
dependent variables (sleep disturbances, depressive symp-toms, and subjective appraisal) were used as covariates inthese analyses.
Prior studies have provided evidence that use of the
Study outcome findings at the end of the 4-week
AlphaStim CES device at identical settings in 3 weeks
improved subjective reports of sleep in persons with
K.M. Rose et al. / Applied Nursing Research 22 (2009) 119–125
these studies of adults with fibromyalgia, stress was measured
with a three-choice ordinal self-rating of quality of sleep,
using the POMS instrument. POMS provides subscale scores
with response options of little or no sleep, moderate sleep,
for anxiety, depression, anger, vigor, fatigue, and cognitive
or good very restful sleep. These studies also demonstrated
function, and a total mood disturbance score (Educational and
reduction in pain and tender points, which are classic
Industrial Testing Service, San Diego, CA). In all three
symptoms of fibromyalgia. Thus, it is plausible that the
studies, positive results for stress alleviation were achieved in
reduction in pain and tender points found in these studies
the active CES groups, whereas these measures of stress
may have influenced the participants' reports of quality of
showed mixed results in persons in the sham CES group.
sleep. These studies also reported improvement in fatigue as
The results of this current pilot study do not support the
measured by the Profile of Mood States (POMS). Other
results of CES on the reduction of stress or caregiving
studies of sleep disorders in persons with fibromyalgia have
appraisal found in other studies. However, the concepts
found that increased pain sensitivity and reports of fatigue in
measured by the PGCCAS may be different in nature from
persons with this disorder are associated with increases in
those measured in the aforementioned studies that used
POMS as a measure of stress. Thus, it is difficult to make
Reports of sleep disturbances related to fatigue and
daytime sleepiness are consistent with documented changesin sleep structure in older people. In this study, slight trends
toward statistically significant differences in participants'
Enrolling only spousal caregivers of persons with AD is a
reports of daily disturbances were found, whereas global
strength of this study. The literature supports the view that
scores of sleep quality did not show these differences.
spousal caregivers experience the caregiving situation
These findings suggest that the CES intervention may have
differently than do persons in other familial roles who are
been affecting other related indicators of sleep, such as
fatigue and daytime sleepiness, that were not directly
report that spousal caregivers exhibit more depressive
measured. The addition of instruments to measure related
symptoms and have other coping difficulties compared to
indicators of sleep, such as fatigue and daytime sleepiness,
other family members who are engaged in the caregiving role.
would strengthen the design of future studies of CES in
By limiting enrollment exclusively to spousal caregivers, the
effects of the intervention were not confounded by the
caregiver's familial role in relation to the care recipient.
In this study, mean baseline scores on the GDS were
Lengthy study protocols for intervention studies have
minimal in both groups (12.84 in the active group and 13.10
been identified as a reason for the high attrition rates of
in the sham group). Although these scores are consistent with
caregivers. The length of time for this study protocol was
the presence of mild depressive symptoms, the internal
4 weeks, as this amount of time has shown beneficial results
consistency of the GDS in this study was low (Cronbach's
in studies using CES. In this study, the attrition rate was low,
= .340). In further support of this low coefficient score,
with only one caregiver dropping out from the study prior to
numerous participants verbalized having difficulty complet-
the 4-week study conclusion time. Participants in this study
ing the GDS because of the format and the wording of some
were able to complete all aspects of the study protocol in
of the scale items. For example, several participants
their home environments. This is a particular strength of the
expressed turmoil with completing Item 10 (“Do you often
study protocol as this feature permitted participants to
feel helpless?”), Item 18 (“Do you frequently worry about the
continue with their daily home routines without the need for
past?”), and Item 19 (“Do you find life very exciting?”) on the
contracting for respite care provisions for the care recipients.
GDS. Participants stated that the adverbs in these items
Numerous study participants verbalized that the ability to
(often, frequently, and very) and in other items made these
stay in their homes and the absence of a need to travel to
items confusing for them and that they were not confident in
participate in this study were strong incentives for their
their responses. Because obtaining a minimal score of 10 on
participation in the study. The study participants demon-
the GDS was required for inclusion into the study, it is
strated a N95% adherence rate with the study protocol,
possible that some of the participants who did not truly
lending further support to the ease of use of the CES device.
exhibit depressive symptoms were enrolled into the study.
No prior published studies of CES and its effect on
Several limitations of this study relate to design. First,
caregiving appraisal were identified. There are, however,
there were only subjective measurements of sleep outcomes
studies of CES and its effects on perceptions of stress—a
used in the study. There is ongoing research regarding
concept that is conceptually close to that of caregiving
correlations between subjective and objective measurements
appraisal. Two of these studies used the AlphaStim device,
of sleep. It has been repeatedly demonstrated that “non-
with settings identical to the settings used in this study
complaining” older men and women manifest significantly
K.M. Rose et al. / Applied Nursing Research 22 (2009) 119–125
disturbed sleep. It is suggested that healthy “noncomplain-
were inactive during this time. Consistent with the literature
ing” older adults appear to adapt their perceptions of what is
regarding the health effects of high adherence to treatment,
“acceptable” sleep and, therefore, do not necessarily
whether active or placebo, the participants in both groups
may have reported improvements in sleep disturbances,
74% of the study participants rated their baseline overall
depressive symptoms, and caregiving appraisal as a result of
health as excellent or very good, and reported minimal, if
the perception of actively working to improve these study
any, sleep disturbances at baseline. Thus, it is possible that
although subjective measurements of sleep did not reveal
sible, as participants in this study reported a 95% adherence
sleep disturbances in this sample, objective measurements
rate to the daily use of the CES device.
may have revealed these difficulties. In future studies, anobjective measurement of sleep, in addition to subjective
measures and sleep-related outcomes (e.g., fatigue anddaytime sleepiness), should be used.
This study was a randomized, double-blind, clinical trial
The small study sample did not allow for adequate power
exploring whether short-term use of CES improved sleep
for study outcome measures. The power analysis for this
disturbances, depressive symptoms, and caregiving appraisal
study was based upon the results of a previous study
in elderly caregivers to spouses with AD. A trend toward
statistically significant differences in reports of daily
were obtained at baseline, with subsequent higher variability
disturbances of sleep was found, with participants in the
in scores than were found in this current study. In future
active CES group demonstrating improvement in this area.
studies of CES in caregiving populations, the results from
Clinically meaningful decreases in sleep latency were found
this current study should be used to perform a more precise
in the active CES group, with a reduction of 9 minutes in the
active group as compared to an increase of 1 minute in the
Additionally, the study design did not control for any
sham group. Depressive symptoms in both intervention
effects the study participants may have experienced from
groups decreased to levels that indicated the absence of
their interactions with the study coordinator or from the use
depressive symptoms. However, these changes were not
of a device as intervention in this study. Participants in both
statistically significant. The limitations of the study may
intervention groups received weekly telephone calls from the
have obscured any effects of CES that may have been
investigator regarding study-related issues (adherence to
prevalent. Thus, a larger sample size, a more precise power
protocol, change in medications). Although most of these
analysis based upon the results of this study, a longer
telephone calls were brief (b5 minutes), several participants'
intervention period of CES, the addition of an attention-
telephone calls lasted N10 minutes. One participant, who was
control group, measurement of other indices of sleep
randomized to the sham group, was blind and, consequently,
(daytime sleepiness, fatigue), and objective measures of
was unable to change the battery in his device every week.
sleep disturbances should be used in future studies of CES in
For this participant, the investigator made weekly visits to
his residence to change the device battery. During theseweekly visits, it was not uncommon for the participant and
his care recipient to invite the investigator to eat snacks or toengage in conversation beyond the purpose of battery
This publication was made possible by grant nos. 5-T32-
change. Thus, it is plausible that this participant, specifically,
AT000052 and 5-K30-AT000060 from the National Center
and all participants, in general, perceived a supportive
for Complementary and Alternative Medicine.
interaction between themselves and the investigator and that
This publication was supported, in part, by a scholarship
this interaction improved their ratings of depressive
provided by the John A. Hartford Foundation's Building
symptoms and caregiving appraisal. Additionally, investiga-
Academic Geriatric Nursing Capacity Scholarship Program.
tions using medical devices, such as the CES device used inthis study, are proposed to have high “placebo effects”().
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