Group Cognitive Behavioral Therapy for Insomnia in Older Adults

November 10, 2022 updated by: Nova Scotia Health Authority

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2E2
        • Sleep Disorders Clinic and Laboratory, QEII Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • patients 65 years and older meeting diagnostic criteria for insomnia

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index
Time Frame: 5 months
a validated questionnaire to assess severity of insomnia symptoms, 7 items
5 months
Pittsburgh Sleep Quality Index
Time Frame: 5 months
a validated questionnaire about quality of sleep, 19 items
5 months
Epworth Sleepiness Scale
Time Frame: 5 months
a validated questionnaire about level of daytime sleepiness, 8 items
5 months
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
5 months
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
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: 5 months
14 item scale to assess feelings of anxiety and depression
5 months
Short Forms Health Survey SF-36
Time Frame: 5 months
quality of life measure
5 months
patient satisfaction survey
Time Frame: 5 months
investigator developed brief questionnaire
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Malgorzata rajda, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2017

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 3763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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