An interventional study of digital CBT-I and Online Sleep Health Education package in Cognitive Dysfunction, Insomnia and Mild Cognitive Impairment, sponsored by University of Sydney. Completed at 1 site in Australia. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by University of Sydney · Not applicable, Interventional, and Treatment
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
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 251 interventional studies indexed under Dyssomnias.
Browse Dyssomnias studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a commercially available 6-week, online media-rich course of CBT-I delivered by an animated "virtual therapist" (Sleepio). Treatment content of this intervention includes behavioural components (sleep restriction, stimulus control, and relaxation), cognitive components (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, and 'putting the day to rest') and educational components (psychoeducation and sleep hygiene). Each of the 6 sessions lasts \~ 30 minutes and incorporates an initial progress review in relation to individualised goals, and exploration of self-reported diary data relating to the participant's current sleep status and pattern. The full program can be accessed via a website or iOS app. Participants will have access to the intervention for up to 12 weeks.
Device: digital CBT-I
Those in the control group will have access to three modules of the Sleep Health Education package following completion of baseline questionnaires. Each module will be delivered fortnightly with basic information about sleep health (e.g. the impact of sleep on health, creating a sleep-conducive bedroom, sleep and mood). Participants will receive a link to access each module as they are made available. At trial completion (week 12), control participants will be offered the opportunity to engage with digital CBT-I.
Other: Online Sleep Health Education package
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.
Also known as: Sleepio
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 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).
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
Overall health status
Overall health status will be assessed using the EuroQol 5-dimension scale, a brief questionnaire about health-related quality of life that queries 5 dimensions of everyday experience that are each rated using a 5-point scale (no problems/slight problems/moderate problems/severe problems/extreme problems) and the overall score range from 0 (worst health state imaginable) to 100 (best health state imaginable). Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Adherence to the online modules
The digital CBT-I program provides online analytics which can be used to monitor adherence by assessing what proportion of patients in the Sleepio arm complete at least 4 sessions. Thus, adherence to the online modules will be determined using a pre-specified value of ≥4 sessions
Time frame: by 12 weeks
Overall engagement to digital CBT-I
Overall engagement to digital CBT-I will be assessed by the User Engagement Scale Short Form (UES-SF). The UES-SF is composed of 12 questions divided between 4 domains: aesthetic appeal (AE), reward (RW), perceived usability (PU) and focused attention (FA). Overall engagement score will be calculated by adding all of the items together and dividing by twelve. The overall score ranges from 1 (low engagement) to 5 (high engagement). This is a tool that has been used to evaluate the main factors for adherence in online interventions.
Time frame: by 12 weeks
Self-report sleep quality
Self-report sleep quality will be determined from the Pittsburgh Sleep Quality Index (PSQI), a 19-items questionnaire with 7 components. Each of these components produces a score ranging from 0 (no difficulty) to 3 (severe difficulty). The components scores are summed to yield a global score (range 0 - 21) with higher total score indicating worse sleep quality. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Self-report sleep efficiency
Self-report sleep efficiency will be determined from the Pittsburgh Sleep Quality Index (PSQI), a 19-items questionnaire with a global score range 0 - 21 with higher total score indicating worse sleep quality. Component 4 of the PSQI will be calculated using the question about sleep duration, bedtime and risetime and analysed as a raw percentage for differences at 12 weeks.
Time frame: baseline and at 12 weeks
Fatigue levels
Fatigue levels will be determined from the Flinders Fatigue Scale (FSS), a 7 items self-report scale which assess fatigue over the past 2 weeks. This scale provides a total fatigue score ranging from 0 to 31, with higher scores indicating greater fatigue. Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Subjective cognitive complaints
Subjective cognitive complaints will be determined from the British Columbia Cognitive Complaints Inventory, a 6-item screening tool that assesses perceived cognitive difficulties in the past 7 days. Each item uses a 3-point Likert scale to capture a rating (0 = not at all; 3= very much) which add up to: broadly normal (0-4); mild cognitive complaints (5-8); moderate cognitive complaints (9-14); and severe cognitive complaints (15-18). Primary endpoint to test for differences is 12 weeks.
Time frame: baseline and at 12 weeks
Target detection (number of correct hits) 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
Probability of False Alarm (False Alarms ÷ (False Alarms + Correct Rejections)) 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
New learning (number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Calculated across all assessed trials) 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 times that the subject chose a wrong stimulus) 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
Perseveration (number of trials for which the outcome was an incorrect response across all assessed trials) 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
Plan to share: Yes — All de-identified data may be shared upon the Principal Investigator's agreement. Ethics approval will be sought prior to any future use of the data.
Supporting information: Study protocol, Icf
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Sydney