Sleep Disturbances in Survivors of Critical Illness Clinical Trial
Official title:
Comparative-effectiveness of Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors
The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and
Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in
survivors of critical illness. Subjects will be recruited following discharge from the
Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective
measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements
will be made by portable (home-based) sleep studies and will wear a watch that measures
sleep. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth
sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at
baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline and
6 weeks.
The central purpose of this proposal is to perform a comparative-effectiveness study of a
complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep
disturbances in survivors of critical illness. The investigators hypothesize that, in
survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in improving
sleep quality (Pittsburgh Sleep Quality Index [PSQI] and sleep efficiency [measured by
polysomnography]).
A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic
markers of inflammation and urinary biomarkers of sleep and stress. The investigators
hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable
to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and
stress.
A tertiary objective is to determine whether the presence of insomnia or other sleep
characteristics is associated with hospital readmissions within 30-days.
Survivors of critical illness are known to have poor quality of life. Specifically,
post-discharge insomnia symptoms were common and significantly associated with physical
quality of life impairment among six-month acute lung injury (ALI) survivors, even after
adjustment for post-traumatic stress disorder (PTSD) and depression symptoms. Further studies
are needed to validate these results and to characterize sleep disturbance after ALI using
sleep-specific metrics. Chronic insomnia impacts 1 in 10 adults and is linked to accidents,
decreased quality of life, diminished work productivity, and increased long-term risk for
medical and psychiatric diseases such as diabetes and depression. Insomnia and inadequate
sleep is an under-recognized problem that ails the investigators society and nearly 8000
preventable deaths per year are attributed to fatigue-related motor vehicle crashes as
compared to 13,000 attributable to drunken driving. In a National Gallup poll, it was
estimated that nearly 70% of US residents do not get adequate sleep. Inadequate sleep has
also been suggested to play a role in the causation and perpetuation of psychiatric disorders
and has recently been labeled a carcinogen. Methods to improve sleep and vitality may
decrease the effects of inadequate sleep and prevent diseases and deaths due to accidents.
Moreover, sleep, or lack thereof, may be a reflection of global stress, disease severity,
reveals much about patients' overall well-being and could be associated with hospital
readmission.
Cognitive-behavioral therapy for insomnia (CBT-I) is currently considered the gold-standard
treatment for insomnia. Recent National Institutes of Health consensus statements and the
American Academy of Sleep Medicine's Practice Parameters recommend that cognitive-behavioral
therapy for insomnia (CBT-I) be considered the first line treatment for chronic primary
insomnia. Growing research also supports the extension of CBT-I for patients with persistent
insomnia occurring within the context of medical and psychiatric co-morbidity. Sedative
medications for insomnia may be associated with adverse side effects and have even been
associated with all-cause mortality. Consequently, other non-pharmacological approaches have
been gaining ground as therapeutic approaches for insomnia. Specifically, complementary and
alternative forms of therapy such as yoga, mindful meditation, tai chi, Reikei and Johrei
therapy have been used to promote sleep quality. Similar to Reikei, Johrei is a
nondenominational spiritual practice and complementary and alternative medical therapy that
channels the purification energy to a human body through the palm of its practitioner. Such
an complementary and alternative treatment has previously been suggested to improve
well-being and vitality in human studies. We know that well-being and vitality are
facilitated by sleep and that sleep deprivation is associated with reduced well-being and
vitality. Moreover, recently we showed that Johrei therapy improves sleep in a murine sleep
deprivation model. Whether Johrei therapy achieves an improved sense of well-being through
facilitation of sleep in survivors of critical illness is unknown. Specifically, whether or
not Johrei therapy is comparable to CBT-I in the management of sleep problems in the
survivors of critical illness is largely unknown. The proposed study will address this
knowledge gap. If Johrei treatment can improve sleep in survivors of critical illness,
patients with reduced vitality due to insufficient sleep (majority of US population),
insomnia, and disrupted sleep (sleep apnea) may also benefit from such treatment.
Insomnia subjects, but not good sleepers, show high levels of pro-inflammatory cytokines that
are associated with increased risk for heart disease and even mortality. Whether the
improvement of sleep through CBT-I or Johrei therapy is mediated by reduction in stress and
pro-inflammatory cytokine levels is unknown. The investigators study will address this
knowledge gap by measuring circulating levels of cytokines in patients receiving Johrei
therapy or CBT-I. Also, recent studies have shown that urinary levels of neurotransmitters
may be increased (catecholamines such as epinephrine, norepinephrine, Ɣ-amino butyric acid
(GABA)) or decreased (Taurine) in subjects with sleep disturbances. Whether or not CBT-I or
other practices aimed at promoting sleep can normalize urinary changes in neurotransmitters
is largely unknown.
A. JT arm: Johrei treatment will be administered to subjects at the University of Arizona or
at the patient's residence for 3 sessions per week lasting 30 minutes each. Two of these
sessions will be combined on one day with a 1 hour interval to yield two visits per week. A
total of 18 sessions will be administered over the 6 weeks of participation. Therapy will be
administered by a senior Johrei administrator who received his training from Reimei Kyokai in
Kyoto, Japan. The Johrei will be administered as per all of the principles of Johrei. Before
each therapy, the therapist will wash his hands and pray for 1 minute while facing the
subject at a distance. The Johrei therapy will be administered without requiring physical
contact by the placement of the therapist's hands in proximity of the subject (20 cms).
Johrei therapy is a complementary and alternative form of therapy that originated in Japan,
like Reiki therapy. Johrei therapy is a non-invasive bio-energy healing practice that is
delivered by the outstretched hand of a Johrei practitioner
(http://www.johrei-institute.org/aboutus.htm). Similar to Reiki, Johrei is a
nondenominational spiritual practice and complementary and alternative medical therapy that
channels the purification energy to a human body through the palm of its practitioner but
without requiring physical touch. Such a complementary and alternative treatment has
previously been suggested to improve well-being and vitality in human studies. We know that
well-being and vitality are facilitated by sleep and that sleep deprivation is associated
with reduced well-being and vitality. Moreover, recently we showed that Johrei therapy
improves sleep in a murine sleep deprivation model.
B. CBT-I arm: Cognitive Behavioral therapy for Insomnia will be administered by a licensed
and trained clinical psychologist after completion of initial assessment of the nature of the
subjects sleep problems via a HIPAA-compliant encrypted Vsee app in the subject's iPAD.
Weekly therapy will be administered in a manner that is tailored to suit the subject's need.
A total of 6 sessions with an option of two additional sessions will be administered to help
promote sleep. The administrator will go over techniques such as sleep restriction therapy,
stimulus control instructions, and sleep hygiene education. Also, in order to prevent
relapse, education will be provided regarding the extent to which they comprehend the
patient's individual circumstances and critically reviewing the rules for good sleep, which
in many instances need to be customized to each subject. All conversations and sessions with
patients will take place in a manner designed to ensure privacy. For ensuring fidelity of the
CBT-I sessions, 20% of the sessions will be video recorded at random for later review by
clinical psychologist.
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