Clincosm LogoSign in Get a demo

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

Sponsor
University of Sydney (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05568381
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
16.5
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: digital CBT-I
  • Other: Online Sleep Health Education package
 N/A

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible participants will be randomly allocated (1:1) to the intervention or wait-listed control arm. Participants allocated to the digital CBT-I arm (intervention) will receive the commercially available program. The program provides an online media-rich course of CBT-I delivered by an animated "virtual therapist". This will be available for participants for 12 weeks. A wait-listed control of sleep health education will consist of 3 modules delivered biweekly of generalised sleep health information that could be found on the internet.Eligible participants will be randomly allocated (1:1) to the intervention or wait-listed control arm. Participants allocated to the digital CBT-I arm (intervention) will receive the commercially available program. The program provides an online media-rich course of CBT-I delivered by an animated "virtual therapist". This will be available for participants for 12 weeks. A wait-listed control of sleep health education will consist of 3 modules delivered biweekly of generalised sleep health information that could be found on the internet.
Masking:
None (Open Label)
Masking Description:
This is an open label study as participants will be informed immediately of their allocated group by an automatic email and/or text message (dependent on participant preference). Therefore, participants will not be blind to treatment allocation. Self-report questionnaires and cognitive tests will be completed online
Primary Purpose:
Treatment
Official Title:
Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Jul 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital Cognitive Behavioural therapy for insomnia

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
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 Names:
  • Sleepio

    		•
    Active Comparator: Sleep Health Education wait-list control

    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
    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.

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of participants who are issued a pre-screening number and then are determined to be eligible to be booked for screening. [During 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.

    2. The proportion of participants who are issued a screening number and then are determined to be eligible for randomisation. [Over a 6-month period of recruitment.]

      We will document the number of participants who consent to the study after all inclusion/exclusion criteria are met.

    3. Percentage of participants who randomised who originally came from the memory clinic and percentage that were randomised who originally came from online recruitment. [Month 0]

      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.

    Secondary Outcome Measures

    1. Insomnia symptom severity [baseline and at 12 weeks]

      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.

    2. 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). [baseline and at 12 weeks]

      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.

    3. Processing speed (median response latency in milliseconds) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). [baseline and at 12 weeks]

      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.

    4. 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. [baseline and at 12 weeks]

      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.

    5. 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. [baseline and at 12 weeks]

      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.

    6. 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). [baseline and at 12 weeks]

      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.

    7. Depressive symptoms [baseline and at 12 weeks]

      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.

    Other Outcome Measures

    1. Overall health status [baseline and at 12 weeks]

      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.

    2. Adherence to the online modules [by 12 weeks]

      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

    3. Overall engagement to digital CBT-I [by 12 weeks]

      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.

    4. Self-report sleep quality [baseline and at 12 weeks]

      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.

    5. Self-report sleep efficiency [baseline and at 12 weeks]

      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.

    6. Fatigue levels [baseline and at 12 weeks]

      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.

    7. Subjective cognitive complaints [baseline and at 12 weeks]

      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.

    8. Target detection (number of correct hits) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). [baseline and at 12 weeks]

      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.

    9. 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). [baseline and at 12 weeks]

      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.

    10. 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. [baseline and at 12 weeks]

      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.

    11. 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). [baseline and at 12 weeks]

      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.

    12. 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). [baseline and at 12 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Sydney Sydney New South Wales Australia 2006

    Sponsors and Collaborators

    • University of Sydney

    Investigators

    • Principal Investigator: Sharon L Naismith, PhD, University of Sydney
    • Principal Investigator: Camilla Hoyos, PhD, University of Sydney

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Sydney
    ClinicalTrials.gov Identifier:
    NCT05568381
    Other Study ID Numbers:
    • 2021/761
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by University of Sydney
    Mild cognitive impairment
    Insomnia
    Cognitive Behavioral Therapy
    Aging
    Sleep
    Digital
    Older people
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Dyssomnias
    Parasomnias
    Sleep Wake Disorders
    Disease
    Cognitive Dysfunction
    Cognition Disorders

    Study Results

    No Results Posted as of Jan 30, 2023