Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention

Mild Cognitive Impairment Clinical Trial

— SUCCEED  

Official title:

Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05568381
• Other study ID #: 2021/761
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: September 2023
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of MCI as defined by a neuropsychologist.
• Able to provide informed electronic consent.
• Fluent English literacy.
• Adults aged between 50-80 years.
• Insomnia symptoms as indicated by a score >10 on the Insomnia Severity Index (ISI).
• Regular computer, smartphone, or tablet use, with internet access.

Exclusion Criteria:

• Previous diagnosis of dementia or a score on the brief Montreal Cognitive Assessment of <18.
• Previous major head injury, cerebrovascular events (stroke, TIA), or loss of consciousness = 30 minutes.
• Previous or current neurological disorder diagnosis (e.g. Parkinson's, multiple sclerosis, epilepsy).
• Current illicit substance use or harmful alcohol intake (Alcohol Use Disorders Identification Test Consumption (AUDIT-C) score > 8).
• Current severe major depression diagnosis as defined by a score >20 on the Patient Health Questionnaire (PHQ-9) and/or suicidal ideation (score of >1 on Q9 of the PHQ-9), or severe psychiatric or developmental disorders (e.g. Schizophrenia, bipolar disorder, autism).
• Major sleep disorders (e.g. narcolepsy, severe restless legs syndrome, and rapid eye movement (REM) sleep behaviour disorder)
• Commencement of continuous positive airway pressure therapy, antidepressants, melatonin or engaged in CBT or psychological interventions within the prior 4 weeks.
• Shift workers, recent (within 30-days) transmeridian travel.
• Older adults with a risk of an increase in daytime sleepiness and decreased alertness (e.g. professional drivers or those who operate heavy machinery).
• Any contraindication to sleep deprivation therapy.
• Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.
• Any medication that has been used to assist sleep for three or more nights per week (e.g. benzodiazepines, sedative hypnotics, opioids) or at the discretion of the clinician.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorder
• Cognitive Dysfunction
• Dyssomnias
• Insomnia
• Mild Cognitive Impairment
• Parasomnias
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Device:
• digital CBT-I
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.

Other:
• Online Sleep Health Education package
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.

Locations

Country	Name	City	State
Australia	The University of Sydney	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	baseline and at 12 weeks
Other	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	by 12 weeks
Other	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.	by 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Other	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.	baseline and at 12 weeks
Primary	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.	During Screening
Primary	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.	Over a 6-month period of recruitment.
Primary	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.	Month 0
Secondary	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.	baseline and at 12 weeks
Secondary	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.	baseline and at 12 weeks
Secondary	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.	baseline and at 12 weeks
Secondary	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.	baseline and at 12 weeks
Secondary	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.	baseline and at 12 weeks
Secondary	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.	baseline and at 12 weeks
Secondary	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.	baseline and at 12 weeks