App-delivered Sleep ThERapy for Older Individuals With Insomnia
NCT ID: NCT05067569
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
270 participants
INTERVENTIONAL
2022-10-01
2025-04-30
Brief Summary
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Detailed Description
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The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.
At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Note: the study project coordinator will not be blinded as they will be managing the study such as sending sleep-tracking wearable devices to the intervention arm and communicating with participants. All investigators and data analysts will be blinded.
Study Groups
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Digital brief behavioural therapy for insomnia
Participants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks.
SleepFix mobile application
The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.
Sleep Health Education wait-list control
Participants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are three modules provided bi-weekly with information about sleep health and broad details about managing sleep disturbances. Participants will receive a link to this information as each module is made available.
Upon completion of the study (week 26), the control group will receive free access to the SleepFix mobile application.
Sleep Health Education
These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.
Interventions
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SleepFix mobile application
The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.
Sleep Health Education
These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.
Eligibility Criteria
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Inclusion Criteria
2. Able to give informed online consent
3. Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
4. English fluency
5. Access to a smartphone and willingness/proficiency to use a mobile app
Exclusion Criteria
2. Travel to a destination with \>2 hours time-difference (within 30-days)
3. Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
4. Diagnosed sleep disorders other than insomnia
5. Regular sleep medications or sleep devices (\>2 times a week over last 6 months)
6. Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
7. Drive for work/operate heavy machinery
60 Years
ALL
No
Sponsors
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University of Sydney
OTHER
Woolcock Institute of Medical Research
OTHER
Responsible Party
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Principal Investigators
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Ronald Grunstein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Woolcock Institute of Medical Research
Christopher Gordon, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sydney
Locations
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Woolcock Institute of Medical Research
Sydney, New South Wales, Australia
Countries
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Related Links
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Woolcock Institute of Medical Research
Faculty of Medicine and Health, The University of Sydney
Other Identifiers
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X21-0265
Identifier Type: -
Identifier Source: org_study_id