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

Royal Prince Alfred Hospital

Status: Not yet enrolling

Conditions: Insomnia

Treatments: Behavioral: SleepFix + e-psychologist support calls; Behavioral: Sleep Health Education (Active control)

Study type: Interventional

Funder types: Other

Identifiers

NCT07405775

2025/ETH19111

Details and patient eligibility

About

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.

Full description

Insomnia is a common sleep disorder among young people, with significant impacts on mental health, daily functioning, and wellbeing. Cognitive Behavioural Therapy for Insomnia (CBTi) is the recommended first-line treatment, and digital delivery offers a scalable way to improve access. Despite strong evidence in the adult literature supporting digital CBTi and standalone individual treatment components of CBTi (e.g., sleep restriction), there is limited research examining their effectiveness and feasibility in young populations.

This pilot, open-label, parallel-group randomised controlled trial will evaluate the feasibility, acceptability, and effects of SleepFix, a smartphone application delivering digital Brief Behavioural Therapy for Insomnia (dBBTi), supported by weekly contact with an e-psychologist, compared to an active control consisting of online Sleep Health Education modules.

Participants (n = 40) aged 16-24 years with insomnia symptoms will be recruited nationally via online advertisements and community networks. Following online pre-screening and a telephone eligibility interview, eligible participants will provide electronic consent and complete baseline questionnaires and a 7-day sleep diary before randomisation (1:1) to one of two groups:

1. Intervention group: Participants will use the SleepFix mobile app, which delivers digital Brief Behavioural Therapy for Insomnia (based primarily on sleep restriction therapy), alongside weekly 15-20minute calls from an e-psychologist for 3 weeks, with an optional additional 3 weeks of therapy.
2. Control group: Participants will receive three online Sleep Health Education modules delivered bi-weekly across a 6-week period. After completing the final follow-up, participants in the control group will be offered access to the SleepFix app and e-psychologist support.

Assessments will occur at baseline, 6 weeks (post-treatment), and 14 weeks (follow-up). The primary outcomes are feasibility measures, including recruitment, consent and randomisation rates, intervention uptake, and data completion. Secondary outcomes include exploring treatment effects on insomnia symptoms (Insomnia Severity Index), sleep-wake metrics from daily sleep diaries, sleep quality, fatigue, mood (depression and anxiety symptoms), and overall acceptability of the intervention.

Participants in the SleepFix intervention group will be invited to take part in a brief post-study interview exploring their experiences and acceptability with the SleepFix app and e-psychologist support.

The study will be conducted entirely online and coordinated from the Woolcock Institute of Medical Research, Sydney, Australia.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment: SleepFix + e-psychologist support calls

Experimental group

Description:

Participants receive the SleepFix mobile application with weekly support calls from an e-psychologist for 3 weeks, with an optional additional 3 weeks of use. SleepFix will deliver digital brief behavioural therapy for insomnia (dBBTi) based on sleep consolidation therapy. The program aims to improve sleep efficiency by tailoring a personalised sleep window and gradually adjusting it. Participants will be instructed to use SleepFix for a 3-week period, with the option to continue for up to an additional 3 weeks. Weekly 15-20 minute sleep support calls from a trained e-psychologist will provide guidance, troubleshooting, and encouragement throughout the intervention period. Participants will also receive access to educational videos on sleep retraining.

Treatment:

Behavioral: SleepFix + e-psychologist support calls

Sleep Health Education (Active Control)

Active Comparator group

Description:

Participants randomised to this arm will receive three online sleep health education modules delivered via email every two weeks over a 6-week period. The modules provide information on sleep and healthy sleep habits. Control group participants will be offered full access to the SleepFix application with the weekly support calls from an e-psychologist after completing their final follow-up assessment at week 14.

Treatment:

Behavioral: Sleep Health Education (Active control)