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

Sponsor
Woolcock Institute of Medical Research
Study ID
NCT07405775
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • SleepFix + e-psychologist support calls — BEHAVIORAL
    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) — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Feb 12, 2026
Start date
Feb 1, 2026
Status verified
Aug 2025
Primary completion
Nov 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment: SleepFix + e-psychologist support calls
    Participants receive the SleepFix mobile application with weekly support calls from an e-psychologist for 3 weeks, with an optional additional 3 weeks of use. SleepFix will deliver digital brief behavioural therapy for insomnia (dBBTi) based on sleep consolidation therapy. The program aims to improve sleep efficiency by tailoring a personalised sleep window and gradually adjusting it. Participants will be instructed to use SleepFix for a 3-week period, with the option to continue for up to an additional 3 weeks. Weekly 15-20 minute sleep support calls from a trained e-psychologist will provide guidance, troubleshooting, and encouragement throughout the intervention period. Participants will also receive access to educational videos on sleep retraining.
  • Active Comparator: Sleep Health Education (Active Control)
    Participants randomised to this arm will receive three online sleep health education modules delivered via email every two weeks over a 6-week period. The modules provide information on sleep and healthy sleep habits. Control group participants will be offered full access to the SleepFix application with the weekly support calls from an e-psychologist after completing their final follow-up assessment at week 14.

Primary Outcome Measure

1. Feasibility measure: Trial efficiency data [ Time Frame: Baseline (Week 0) ]

Central Contacts

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