Phone app with personalised tips for people with sleep and body clock problems

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in Hong Kong who have had sleep or body-clock problems for 3 months. They use a smartphone app called GoodShleep for 8 weeks.

Age

18 to 65 years

Sex

All sexes

Disease stage

At least 1 sleep or body-clock problem for 3 months. Examples: needing ≥30 minutes to fall asleep, or being awake ≥30 minutes after falling asleep, on ≥3 nights per week. Others: <6-hour or ≥9-hour sleep on ≥3 nights per week, sleep times varying ≥2.78 hours within a week, or falling asleep after 2:00 AM on ≥3 nights per week. One or more PROMIS-Sleep Disturbance item scores of ≥4 after reverse scoring. People must have the chance and conditions to sleep.

Earlier treatment

People who had any psychological treatment for sleep problems in the past 6 months cannot join.

Main reasons for not taking part

• Serious untreated mental illness, such as bipolar disorder or psychotic disorder
• Medical or memory and thinking problems, or drug side effects, that strongly cause the sleep problems or make taking part hard
• Night shift work (>2 nights per week) in the past 3 weeks
• Pregnancy or breastfeeding
• A medical or mental health condition that could get worse with limited sleep time

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 65 years old?YesNo

What the trial wants to find out

The JITAI approach holds considerable promise for addressing current challenges in mHealth, including the limitations in supporting real-time monitoring, timely intervention, and poor adherence. However, research on JITAIs in the field of behavioural sleep medicine is still in its infancy. Leveraging existing pilot data, this project will entail a micro-randomised trial (MRT) designed to optimise the JITAI components and a randomised controlled trial (RCT) to examine the efficacy of the optimised JITAI on sleep and circadian functions. Specifically, research has indicated that contextually tailored suggestions are more effective in promoting health behaviors compared to generic messages. This study will include personalised, in-the-moment actionable suggestions based on the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to evaluate their efficacy in contrast to generic messages and no notifications.

The group in the trial

• Just-in-time adaptive intervention (GoodShleep) groupTreatment being tested

  Participants will be micro-randomised to the delivery of the behavioural components at each of the 4 decision points daily, with a 37.5% chance of being micro-randomised to contextually personalised suggestions, 37.5% to generic messages, and 25% to no notifications. The randomisation process will be independent to prior randomisations and the participants' responses to previously delivered intervention suggestions. 1. Context-based behavioural strategies based on TranS-C will be suggested through push notifications if specific decision rules are met at specific decision points. 2. Participants will receive non-personalised standard messages instead of personalised suggestions based on the TranS-C. These messages will be sent to acknowledge their sleep problems and provide general encouragement to consider taking action to improve their conditions. 3. This group will not receive specific notifications encouraging them to make changes.

  Treatment: Just-in-time adaptive intervention (JITAI) based on TranS-C (GoodShleep)