InsomniaNCT03117777
Group Cognitive Behavioral Therapy for Insomnia in Older Adults
An observational study of Insomnia, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- group cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2017to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients 65 years of age and older, who meet diagnostic criteria for insomnia disorder defined as difficulty initiating or maintaining sleep associated with daytime impairment, occurring at least 3 nights per week for at least 3 months.
Who may be able to join
- patients 65 years and older meeting diagnostic criteria for insomnia
Who cannot join
- significant physical or cognitive impairment that prevent the patients from participating in behavioural intervention (e.g. getting out of bed on their own) or cognitive intervention (e.g. learning sleep psychoeducation)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sleep Disorders Clinic and Laboratory, QEII Health Sciences Centre
Halifax, Nova Scotia, B3H2E2
About this study
Official title: Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in OIder Adults: the Clinical Outcomes of a Pilot Project
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.
Read the detailed 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.
- Conditions
- Insomnia
- Being tested
- group cognitive behavioral therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group cognitive behavioral therapy for insomniaBehavioural
cognitive behavioral therapy for insomnia delivered in group setting for older adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
a validated questionnaire to assess severity of insomnia symptoms, 7 items
Measured: 5 months
Pittsburgh Sleep Quality Index
a validated questionnaire about quality of sleep, 19 items
Measured: 5 months
Epworth Sleepiness Scale
a validated questionnaire about level of daytime sleepiness, 8 items
Measured: 5 months
Dysfunctional Beliefs and Attitudes about Sleep Questionnaire
a validated questionnaire to assess the patients core beliefs about their sleep, 16 items
Measured: 5 months
Sleep logs
standard instrument used in cognitive behavioral therapy of insomnia, patient fills out data regarding sleep duration and time-in-bed duration, time to sleep onset, time awake after sleep onset, allows to evaluate sleep patterns and calculate sleep efficiency
Measured: 5 months
Secondary outcomes (3)
Hospital Anxiety and Depression Scale
14 item scale to assess feelings of anxiety and depression
Measured: 5 months
Short Forms Health Survey SF-36
quality of life measure
Measured: 5 months
patient satisfaction survey
investigator developed brief questionnaire
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startOct 2017 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: REB approval denied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata rajda, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117777
- Sponsor's protocol ID
- 3763
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2017
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in OIder Adults: the Clinical Outcomes of a Pilot Project
- ClinicalTrials.gov ID
- NCT03117777
- Acronym / sponsor ID
- 3763
- Conditions
- Insomnia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: REB approval denied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients 65 years of age and older, who meet diagnostic criteria for insomnia disorder defined as difficulty initiating or maintaining sleep associated with daytime impairment, occurring at least 3 nights per week for at least 3 months.
Key inclusion criteria (1 listed)
- patients 65 years and older meeting diagnostic criteria for insomnia
Key exclusion criteria (1 listed)
- significant physical or cognitive impairment that prevent the patients from participating in behavioural intervention (e.g. getting out of bed on their own) or cognitive intervention (e.g. learning sleep psychoeducation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group cognitive behavioral therapy for insomniacognitive behavioral therapy for insomnia delivered in group setting for older adults | Behavioural | – |
Primary outcome
Insomnia Severity Index
Time frame: 5 months
a validated questionnaire to assess severity of insomnia symptoms, 7 items
Pittsburgh Sleep Quality Index
Time frame: 5 months
a validated questionnaire about quality of sleep, 19 items
Epworth Sleepiness Scale
Time frame: 5 months
a validated questionnaire about level of daytime sleepiness, 8 items
Dysfunctional Beliefs and Attitudes about Sleep Questionnaire
Time frame: 5 months
a validated questionnaire to assess the patients core beliefs about their sleep, 16 items
Sleep logs
Time frame: 5 months
standard instrument used in cognitive behavioral therapy of insomnia, patient fills out data regarding sleep duration and time-in-bed duration, time to sleep onset, time awake after sleep onset, allows to evaluate sleep patterns and calculate sleep efficiency
3 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: 5 months
Short Forms Health Survey SF-36
Time frame: 5 months
patient satisfaction survey
Time frame: 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata rajda principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.