Clinical Trial

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

Study acronym: iSLEEPY
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07405775
Lead Sponsor Woolcock Institute of Medical Research
Collaborators: Macquarie University, Australia
Conditions Insomnia
Enrollment 40 participants
Start Date 2026-02-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-12