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

Sponsor: Woolcock Institute of Medical Research • ClinicalTrials.gov ID: NCT07405775

Registry updated: 2026-08-19

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Description

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.

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.

Eligibility criteria

Inclusion Criteria: * 16 -24 years old * Able to give informed online consent and if younger \<18years old guardian/parental consent * Insomnia Severity Index ≥ 10 * English fluency * Access to a smartphone and willingness to use a mobile app for healthcare Exclusion Criteria: * Shift-workers with regular shifts between the hours of 8pm and 8am. * Recent travel to a destination with \>2 hours time difference (within last 7-days and with subjective reports that they are not experiencing jet lag). * Serious medical and/or psychiatric illnesses/disorders (e.g., Epilepsy or other seizure disorders, heart failure, bipolar disorder, schizophrenia, Major Depressive disorder) * Self-reported/diagnosed sleep disorders other than insomnia (e.g. - Obstructive Sleep Apnoea, REM/NREM sleep disorders, Restless Leg Syndrome, Narcolepsy, free running cycle \& Circadian rhythm disorder) * Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT). * Pregnant * Professional driver or operate heavy machinery

Conditions

Insomnia

Locations

Woolcock Institute of Medical Research — Sydney, New South Wales, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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