This study aims to determine the feasibility of a randomized-controlled trial of digital cognitive behavioural therapy for insomnia (CBT-I) for sleep and cognitive performance in older adults with MCI and insomnia symptoms (50-80 years). The trial will be completed online, and participants will be recruited from the community across Australia.
Insomnia is a highly prevalent sleep disorder which affect approximately 10% of the adult population and 40% of the older population. Further, insomnia has been linked to an increased risk of developing dementia. Currently, the recommended first-line treatment for insomnia is cognitive behavioural therapy for insomnia (CBT-I), in both face-to-face and digital form. Despite the strong evidence for digital CBT-I, there are insufficient data regarding the benefits and effectiveness of digital CBT-I in older people with mild cognitive impairment (MCI). The investigators will conduct a fully online study comparing 6-weeks of digital behavioural therapy for insomnia (CBT-I) against online sleep health education. Participants will be recruited using social media, as well as from memory clinics. Participants will be screened and determined eligibility and consent will be conducted online. Subsequently, participants will be randomly allocated to either digital CBT-I delivered via an application called Sleepio or wait-listed control. The Sleepio app is a sleep-improvement program that uses cognitive behavioural therapy techniques to improve insomnia symptoms. The wait-listed control will consist of 3 modules of an online Sleep Health Education package delivered fortnightly with non-tailored basic sleep information. They will be directed to a website to determine eligibility and then provided access to either the digital CBT-I (Sleepio) or the wait-listed control with a link to the first online module. At baseline, all participants will complete self-reported measures of subjective cognitive complaints, insomnia, fatigue, sleep, depression, quality of life, and digital health literacy. Also, they will complete three web-based cognitive assessments that measure memory, processing speed, and executive functioning. These will be repeated at follow-up at weeks 12
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Sleepio is a digital cognitive behavioral therapy (CBT) program designed to treat insomnia. The program is fully automated, and its underlying algorithms drive the delivery of information, support, and advice.
Wait-listed control participants will have full access to three online modules for the duration of the study. The information in these modules will provide non-tailored basic sleep information and content will contain text and basic images but will not be personalised to the individual participant.
The University of Sydney
Sydney, New South Wales, Australia
The proportion of participants who are issued a pre-screening number and then are determined to be eligible to be booked for screening.
The aim is to provide feasibility data for a full-scale randomized controlled trial (RCT). We will document the number of participants who are eligible after the screening process.
Time frame: During Screening
The proportion of participants who are issued a screening number and then are determined to be eligible for randomisation.
We will document the number of participants who consent to the study after all inclusion/exclusion criteria are met.
Time frame: Over a 6-month period of recruitment.
Percentage of participants who randomised who originally came from the memory clinic and percentage that were randomised who originally came from online recruitment.
An aim of this trial is to determine the feasibility of recruiting through memory clinics and/or online advertising. We will document the number of participants who have been recruited through memory clinics or online advertising.
Time frame: Month 0
Insomnia symptom severity
Insomnia symptoms severity will be determined from the Insomnia Severity Index (ISI), a 7-item patient reported outcome measure that probes the severity of current symptoms of insomnia over the past 2 weeks. Each item uses a 5-point Likert scale to capture a rating (0 = no problem; 4 = very severe problem) which add up to: no insomnia (0 - 7); sub-threshold insomnia (8 - 14); moderate insomnia (15 - 21); and severe insomnia (22 - 28). Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Target detection (A'; the accuracy with which a subject detects targets (the expected range is 0.00 to 1.00)) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB).
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Masking
NONE
Enrollment
40
The RVP is a web-based test from CANTAB that measures sustained attention. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Processing speed (median response latency in milliseconds) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB).
The RVP is a web-based test from CANTAB that measures sustained attention. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Adjusted perseveration (number of times that the subject chose a wrong stimulus adjustment for every stage that was not reached) as assessed by Intra-Extra Dimensional Set Shift (IED) subtest from CANTAB.
The IED is a web-based test from CANTAB that assess executive functioning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Visual memory (number of times the subject chose the incorrect box for a stimulus adjusted for the estimated number of errors on trials not completed) as assessed by the Paired Associate Learning (PAL) subtest from CANTAB.
The PAL is a web-based test from CANTAB that assess visual memory and new learning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Problem solving (number of trials completed on all attempted stages with an adjustment for any stages not reached) as assessed by Intra-Extra Dimensional Set Shift (IED) subtest from the Cambridge Neuropsychological Test Automatic Battery (CANTAB).
The IED is a web-based test from CANTAB that assess executive functioning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Depressive symptoms
Depressive symptoms will be assessed by the Geriatric Depression Scale (GDS) which is a 15-item self-report questionnaire that has been developed to assess depressive symptoms This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points where higher scores indicate more severe depressive symptoms. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks