Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03117777 |
| Other study ID # |
3763 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2017 |
| Est. completion date |
May 2019 |
Study information
| Verified date |
November 2022 |
| Source |
Nova Scotia Health Authority |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is a quality assurance project to evaluate a therapy program offered to patients in
Sleep Disorders Clinic. Group Cognitive Behavioral Therapy for Insomnia (CBT-I) is being
offered to older adults. The study will consist of analyzing outcomes of a clinical program.
As part of standard clinical process, patients complete measurements of sleep, daytime
functioning, fatigue, quality of life, depression and anxiety symptoms before and after the
treatment. The proposed study will pool and quantitatively analyze the existing clinical
data. Only those program participants who consent to have their data pooled in the data
analysis will be considered research subjects. Those patients who decline to have their
individual data included in the analysis will continue in the therapeutic group as per usual
clinical care standards.
CBT-I is a gold standard treatment for people suffering from insomnia but it is difficult to
access due to a shortage of trained therapists. Insomnia prevalence increases with age and is
a common sleep disturbance in the elderly. Offering the group treatment can increase access
and reduce healthcare costs associated with sleep problems in the elderly.
Description:
Insomnia is a sleep disorder defined as difficulty initiating or maintaining sleep at least 3
nights per week for at least 3 months and is associated with daytime impairment. The
prevalence of insomnia is high, approximately 10% in the general population. Symptoms of
insomnia (i.e. sleep difficulties in the absence of a full diagnosis) are even more common,
with prevalence higher than 30%. The rate of insomnia symptoms in elderly populations is even
higher, with approximately 50% of older adults regularly complaining about significant sleep
disturbances.
Over the age of 50 years, the likelihood of a sleep problem increases as a result of a number
of factors. Changes to the circadian rhythm can lead to falling asleep and waking earlier
than desired. Deep sleep decreases with age, as a result nightly awakenings become more
common. Co-morbidities causing nocturnal urination and joint pain can also affect sleep in
older adults. These common sleep changes, along with environmental and psychological factors,
can precipitate insomnia. Once disturbed sleep occurs, cognitive and behavioral factors such
as dysfunctional beliefs about sleep or maladaptive sleep habits can perpetuate insomnia.
Sleep disturbance in older adulthood is associated with negative consequences across broad
areas of functioning. For example, cognitive problems resulting from sleep disturbance can
include increased difficulty with attention, memory and response time. Physical issues such
as increased pain, falls and increased mortality rates are also associated with sleep
disturbance in the elderly.
Due to the sizeable increase in sleep disturbances and the associates risks in older adults,
access to safe and effective treatment becomes imperative. The increasing numbers of older
adults in the general population ("the rising tide") will create a demand for practical means
of delivering the necessary healthcare in a sustainable and practical way.
Medication (i.e. sedative hypnotics) may improve sleep parameters in elderly populations,
however sleep problems generally resurface after discontinuation of medication. Additionally,
the risk of adverse events created by sedative hypnotics, such as gait disturbance and
cognitive impairment, is significant. Primarily due to the high risks associated with
sedative hypnotics, they are not recommended as a fist-line treatment for insomnia. In
situations where sedative hypnotics are prescribed, the recommended use duration is maximum 2
weeks.
The recommended treatment for insomnia, endorsed by clinical guidelines (e.g. the Canadian
Medical Association and the American Academy of Sleep Medicine) is Cognitive Behavioural
Therapy for Insomnia (CBT-I). CBT-I is also endorsed as a first-line treatment for seniors.
CBT-I programs for seniors have been found to be effective in significantly increasing both
sleep quality and sleep quantity.
Despite their effectiveness, CBT-I programs are often inaccessible due to Canada-wide limited
resources and lack of trained professionals. CBT-I group programs have been introduced as a
strategy for increasing access to insomnia treatment. Group programs fr the general adult
population have been found to be similarly effective when compared with individual CBT-I,
supporting this format for treatment.
Older adults have been shown to have unique sleep problems and sleep needs, and there is
evidence of a good treatment response in individual therapy, however the effectiveness of
group CBT-I has not been evaluated with this population. With the increased prevalence of
insomnia in older adults, it is important that safe and effective treatment be available. The
proposed project will therefore involve pilot testing of a group CBT-I program for seniors.
It is hypothesized that seniors will improve in subjective sleep quality and sleep quantity
after completing the intervention.
Research Question:
Is group CBT-I acceptable as a treatment of late-life insomnia, and does it result in
subjective sleep improvements?
Methods:
The group therapy will take place in Sleep Disorders Clinic and will be offered to patients
with insomnia referred from the community. The CBT-I groups will contain 6-10 patients each
and will be run 10 times over a period of 24 months, for a maximum of 60 patients.
This is a quality assurance project to evaluate a therapy program offered to patients in
Sleep Disorders Clinic. Group Cognitive Behavioral Therapy for Insomnia (CBT-I) is being
offered to older adults. The study will consist of analyzing outcomes of a clinical program.
As part of standard clinical process, patients complete measurements of sleep, daytime
functioning, fatigue, quality of life, depression and anxiety symptoms before and after the
treatment. The proposed study will pool and quantitatively analyze the existing clinical
data. Only those program participants who consent to have their data pooled in the data
analysis will be considered research subjects. Those patients who decline to have their
individual data included in the analysis will continue in the therapeutic group as per usual
clinical care standards.
