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

Status: Recruiting

Location: See location...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 16

Maximum Age: 24

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

Australia

Woolcock Institute of Medical Research

RECRUITING

Sydney

Contact Information

Primary

Yael Galgut, PhD Candidate

yael.galgut@woolcock.org.au

+61431333923

Backup

Prof Delwyn Bartlett

delwyn.bartlett@woolcock.org.au

Time Frame

Start Date: 2026-04-10

Estimated Completion Date: 2027-11-01

Participants

Target number of participants: 40

Treatments

Experimental: Treatment: SleepFix + e-psychologist support calls

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.

Active_comparator: Sleep Health Education (Active Control)

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.

Related Therapeutic Areas

Insomnia

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