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

This trial has no sites in United States.

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Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 24 years old?

Source: NCT07405775, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Woolcock Institute of Medical Research
Trial code
NCT07405775
Record updated
19 August 2026
Original 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.Read full original descriptionShow less

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.

Inclusion: 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: Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT); 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); 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); Pregnant; Professional driver or operate heavy machinery.

ClinicalTrials.gov NCT07405775