NCT05568381

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-20
• Primary completion: 2023-08-10
• Completion: 2023-11-17
• First posted: 2022-10-05
• Last updated: 2024-05-28

Locations

1 site across 1 country: Australia