SleepFix for Youth: Digital Behavioural Therapy for Insomnia With E-Psychologist Support

Condition(s) studied

Investigational drug(s) / intervention(s)

SleepFix + e-psychologist support calls: SleepFix mobile application uses Sleep Retraining Therapy (SRT) which aims to reduce excess time spent in bed awake and reset sleep by matching time in bed to total sleep time (TST). There are four stages to the SleepFix app and participants will progress based on completion of each stage. Participants are required to enter sleep and bedtime/wake data into the smartphone app for baseline referencing and determination of sleep therapy. SleepFix uses an algorithm that calculates optimal sleep efficiency based on participants data

Sleep Health Education (Active control): Three online sleep health education modules are provided to participants. It included information about healthy sleep, insomnia, sleep hygiene practices and information on general strategies for managing sleep for insomnia.

Study summary

This pilot randomised, open-label, parallel-group controlled trial will evaluate the feasibility, acceptability and effects of a psychologist-supported digital behavioural therapy for insomnia (dBTi) compared to a wait-listed active control (digital sleep health education) in young people aged 16-24 years with insomnia symptoms.

The primary objectives are to evaluate the feasibility of conducting a full-scale trial by assessing recruitment, consent and randomisation rates, intervention uptake, and data completeness. Secondary objectives include exploring treatment effects on insomnia severity (Insomnia Severity Index), sleep diary metrics, sleep quality, fatigue, and mood (depression and anxiety symptoms). Post-intervention interviews will assess participant experience and acceptability.

Results will inform the design of a larger randomised controlled trial.

Eligibility

Primary outcome measure(s)

• 1. Feasibility measure: Trial efficiency data — Baseline (Week 0)
  To evaluate feasibility based on trial efficiency. Data will be assessed by: 1. the proportion of participants who are issued an online pre-screening number and then meet criteria for telephone screening; 2. the proportion of participants who are issued a telephone screening number indicating eligibility and then provide consent; 3. the proportion of participants who provide consent and then are randomised into the trial.
• 2. Feasibility measure: Intervention uptake — 6 weeks
  To evaluate feasibility based on Intervention uptake. Data will be assessed by: a. the proportion of participants randomised to SleepFix intervention group who download the SleepFix app and then enter personalised data to obtain a prescribed sleep restriction window.
• Feasibility measure: Data Completion of Insomnia Severity Index — Week 6 and Week 14
  The 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. All items are summed with total scores ranging from 0-28. Higher scores indicate more severe insomnia. The investigators will count the proportion of participants randomised that successfully complete the ISI at Week 6 and Week 14 (this is two outcomes).

Trial sites (1)

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