App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID)

Royal Prince Alfred Hospital

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Sleep Health Education; Behavioral: SleepFix mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05067569

X21-0265

Details and patient eligibility

About

This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.

Full description

Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population.

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.

Enrollment: 270 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Older adults aged ≥ 60 years
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

1. Shift-workers
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

Digital brief behavioural therapy for insomnia

Experimental group

Description:

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.

Treatment:

Behavioral: SleepFix mobile application

Sleep Health Education wait-list control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sleep Health Education