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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized trial compares SleepFix, a digital brief behavioral therapy for insomnia delivered through a smartphone app with weekly e-psychologist calls, to a digital sleep-education control in youths aged 16-24 with insomnia symptoms. The study will assess feasibility metrics (recruitment, consent, randomization, engagement, and data completeness) and preliminary effects on insomnia severity, sleep diaries, sleep quality, fatigue, and mood. Outcome data and post-intervention interviews will inform the design of a larger, definitive trial. Insomnia in young people can impact mental health and daily functioning, and digital CBTi approaches may improve access to effective treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Woolcock Institute of Medical Research
  Sydney, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Professor Delwyn Bartlett — Woolcock Institute of Medical Research
• Study coordinator: Yael Galgut, PhD Candidate
• Email: yael.galgut@woolcock.org.au
• Phone: +61431333923

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.