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Recruiting NCT07405775

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

Conditions: Insomnia

Sex: All
Ages: 16 Years – 24 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Woolcock Institute of Medical Research

Location: Woolcock Institute of Medical Research Sydney New South Wales

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 Criteria

Inclusion Criteria: * 16 -24 years old * Able to give informed online consent and if younger \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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07405775). StuddyBuddy aggregates publicly available trial information.