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Completed

NCT Number: NCT05067569

App-delivered Sleep ThERapy for Older Individuals With Insomnia

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woolcock Institute of Medical Research

Sydney, New South Wales, 2037, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older adults aged ≥ 60 years
  • Able to give informed online consent
  • Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
  • English fluency
  • Access to a smartphone and willingness/proficiency to use a mobile app

Exclusion criteria

  • Shift-workers
  • Travel to a destination with >2 hours time-difference (within 30-days)
  • Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
  • Diagnosed sleep disorders other than insomnia
  • Regular sleep medications or sleep devices (>2 times a week over last 6 months)
  • Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
  • Drive for work/operate heavy machinery

Treatment and study plan

SleepFix mobile application

Behavioral

The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.

Sleep Health Education

Behavioral

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.

Primary outcomes

  1. Change in insomnia symptom severity

    Time frame: Change score from baseline at 8 weeks

    Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.

Secondary outcomes

  1. Change in subjective sleep quality

    Time frame: Change score from baseline at 8 weeks

    Subjective sleep quality will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with seven component scores derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.

  2. Change in sleep onset latency

    Time frame: Change score from baseline at 8 weeks

    Sleep onset latency will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess sleep onset latency over the last 2 weeks.

  3. Change in wake after sleep onset

    Time frame: Change score from baseline at 8 weeks

    Wake after sleep onset will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess wake after sleep onset over the last 2 weeks.

  4. Change in total sleep time

    Time frame: Change score from baseline at 8 weeks

    Total sleep time will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess total sleep time over the last 2 weeks.

  5. Change in fatigue

    Time frame: Change score from baseline at 8 weeks

    The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from "not at all" = 0 to "extremely" = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue.

  6. Change in daytime sleepiness

    Time frame: Change score from baseline at 8 weeks

    The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire that provides a rating of general sleepiness over the last 2 weeks using a 4-point likert scale from "would never dose" = 0 to "high chance of dozing" = 3. All items are summed with total scores ranging from 0-26 where scores >10 indicating above-average daytime sleepiness.

  7. Change in quality of Life

    Time frame: Change score from baseline at 8 weeks

    The EuroQol five-dimensional (EQ-5D) is a self-reported questionnaire which assesses 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and overall health. The 5 dimensions range from "1 = indicating no problem" - "5 = indicating unable to/extreme problems" and the overall score from 0 (worst health state imaginable) to 100 (best health state imaginable).

  8. Change in depressive symptoms

    Time frame: Change score from baseline at 8 weeks

    The Patient Health Questionnaire-9 is a 9-item self-reported measure of depressive symptoms over the past 2 weeks. Scores for each question (Likert type scale "not at all" = 0 to "nearly every day" = 3) sum to a total score out of 27 with higher scores reflecting severe depressive symptoms.

  9. Change in anxiety

    Time frame: Change score from baseline at 8 weeks

    The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety over the previous 2 weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.

  10. Change in self-reported cognition

    Time frame: Change score from baseline at 8 weeks

    The British Columbia Cognitive Complaints Inventory (BC-CCI) is a 6-item tool to assess self-perceived cognition. It explores any perceived problems associated with cognition, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems in reflection of the last 7 days. Answers for each question range from 0 (= "not at all") to 3 (= "Very much"). Scores are summed to a total out of 18 that reflects the cognitive complaint severity.

  11. Engagement

    Time frame: Baseline, week 8

    To determine if there is a relationship between therapeutic outcome (Insomnia Severity Index, ISI) and engagement (number of in-app sleep diary entries for study completers)

  12. The effect of baseline digital health literacy on therapy efficacy

    Time frame: Baseline, week 8

    Digital health literacy will be assessed using the eHEALS Literacy Scale (eHEALS) which is an 8-item, 5-point Likert-type questionnaire that measures a participant's perception of, and ability toward electronic health information. Responses range from "strongly disagree" =1, to "strongly agree" = 5. Total scores are summed to range from 8 to 40 where lower scores indicate lower self-reported digital health literacy.

    The moderating effect of the baseline digital health literacy on therapeutic outcomes (ISI scores) and engagement (number of daily sleep diary entries) will be assessed.

Sponsors and collaborators

Lead sponsor

Woolcock Institute of Medical Research

Other

Collaborators

  • University of Sydney

Registry information

Official study title

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

Acronym: ASTEROID

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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