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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05568381




Registration number
NCT05568381
Ethics application status
Date submitted
23/08/2022
Date registered
5/10/2022

Titles & IDs
Public title
Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention
Scientific title
Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED)
Secondary ID [1] 0 0
2021/761
Universal Trial Number (UTN)
Trial acronym
SUCCEED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Dysfunction 0 0
Insomnia 0 0
Mild Cognitive Impairment 0 0
Cognitive Disorder 0 0
Sleep Wake Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - digital CBT-I
Other interventions - Online Sleep Health Education package

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.

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.


Treatment: Devices: 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 interventions: 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants who are issued a pre-screening number and then are determined to be eligible to be booked for screening.
Timepoint [1] 0 0
During Screening
Primary outcome [2] 0 0
The proportion of participants who are issued a screening number and then are determined to be eligible for randomisation.
Timepoint [2] 0 0
Over a 6-month period of recruitment.
Primary outcome [3] 0 0
Percentage of participants who randomised who originally came from the memory clinic and percentage that were randomised who originally came from online recruitment.
Timepoint [3] 0 0
Month 0
Secondary outcome [1] 0 0
Insomnia symptom severity
Timepoint [1] 0 0
baseline and at 12 weeks
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
baseline and at 12 weeks
Secondary outcome [3] 0 0
Processing speed (median response latency in milliseconds) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB).
Timepoint [3] 0 0
baseline and at 12 weeks
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
baseline and at 12 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
baseline and at 12 weeks
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
baseline and at 12 weeks
Secondary outcome [7] 0 0
Depressive symptoms
Timepoint [7] 0 0
baseline and at 12 weeks

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2023
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon L Naismith, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
The study data will be available following all analyses.
Available to whom?
Contact the Principal Investigator to access the data.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05568381