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

NCT ID: NCT05568381

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-11-17

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.

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

Conditions

Cognitive Dysfunction; Insomnia; Mild Cognitive Impairment; Cognitive Disorder; Sleep Wake Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

digital CBT-I

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Online Sleep Health Education package

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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 Type: OTHER

Other Intervention Names

Sleepio

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon L Naismith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Camilla Hoyos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

The University of Sydney

Sydney, New South Wales, Australia

Countries

Australia

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Other Identifiers

2021/761

Identifier Type: -

Identifier Source: org_study_id