Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED)
Cognitive Dysfunction, Insomnia, Mild Cognitive Impairment
About this trial
This is an interventional treatment trial for Cognitive Dysfunction focused on measuring Mild cognitive impairment, Insomnia, Cognitive Behavioral Therapy, Aging, Sleep, Digital, Older people
Eligibility Criteria
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.
Sites / Locations
- The University of Sydney
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Digital Cognitive Behavioural therapy for insomnia
Sleep Health Education wait-list control
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.
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.