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

NCT07405775 | Not Yet Recruiting

• 1 other identifier: 2025/ETH19111
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Insomnia

Keywords

young people; adolescents; insomnia; CBTi; digital behavioural therapy for insomnia; sleep restriction therapy

Outcome Measures

Primary Outcomes (3)

• 1. Feasibility measure: Trial efficiency data

  To evaluate feasibility based on trial efficiency. Data will be assessed by: 1. the proportion of participants who are issued an online pre-screening number and then meet criteria for telephone screening; 2. the proportion of participants who are issued a telephone screening number indicating eligibility and then provide consent; 3. the proportion of participants who provide consent and then are randomised into the trial.

  Baseline (Week 0)

• 2. Feasibility measure: Intervention uptake

  To evaluate feasibility based on Intervention uptake. Data will be assessed by: a. the proportion of participants randomised to SleepFix intervention group who download the SleepFix app and then enter personalised data to obtain a prescribed sleep restriction window.

  6 weeks

• Feasibility measure: Data Completion of Insomnia Severity Index

  The Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. All items are summed with total scores ranging from 0-28. Higher scores indicate more severe insomnia. The investigators will count the proportion of participants randomised that successfully complete the ISI at Week 6 and Week 14 (this is two outcomes).

  Week 6 and Week 14

Secondary Outcomes (15)

• Effects of the SleepFix intervention on ISI scores

  Week 6 and Week 14

• Assessing data completeness: 7-day sleep diaries

  Week 6 and week 14

• Assessing data completeness: Brief Pittsburgh Sleep Quality Index (B-PSQI)

  Week 6 and Week 14

• Assessing data completeness: The Flinders Fatigue Scale (FFS)

  Week 6 and Week 14

• Assessing data completeness: Patient Health Questionnaire-2 (PHQ-2)

  Week 6 and Week 14

Other Outcomes (1)

• Number e-psychologist support calls accessed

  Week 6

Study Arms (2)

Treatment: SleepFix + e-psychologist support calls

EXPERIMENTAL

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.

Behavioral: SleepFix + e-psychologist support calls

Sleep Health Education (Active Control)

ACTIVE COMPARATOR

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.

Behavioral: Sleep Health Education (Active control)

Interventions

SleepFix + e-psychologist support calls BEHAVIORAL

SleepFix mobile application uses Sleep Retraining Therapy (SRT) which aims to reduce excess time spent in bed awake and reset sleep by matching time in bed to total sleep time (TST). There are four stages to the SleepFix app and participants will progress based on completion of each stage. Participants are required to enter sleep and bedtime/wake data into the smartphone app for baseline referencing and determination of sleep therapy. SleepFix uses an algorithm that calculates optimal sleep efficiency based on participants data

Also known as: sleep restriction therapy, sleep consolidation therapy, sleep retraining therapy

Treatment: SleepFix + e-psychologist support calls

Sleep Health Education (Active control) BEHAVIORAL

Three online sleep health education modules are provided to participants. It included information about healthy sleep, insomnia, sleep hygiene practices and information on general strategies for managing sleep for insomnia.

Also known as: sleep education

Sleep Health Education (Active Control)

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead
• Macquarie University, Australia: collaborator

Related Publications (8)

• Aji M, Glozier N, Bartlett DJ, Grunstein RR, Calvo RA, Marshall NS, White DP, Gordon C. The Effectiveness of Digital Insomnia Treatment with Adjunctive Wearable Technology: A Pilot Randomized Controlled Trial. Behav Sleep Med. 2022 Sep-Oct;20(5):570-583. doi: 10.1080/15402002.2021.1967157. Epub 2021 Aug 20.

  PMID: 34415819 BACKGROUND

• Gordon CJ, Cheung JMY, Schrire ZM, Rahimi M, Aji M, Salomon H, Doggett I, Glozier N, Wong KKH, Marshall NS, Bartlett DJ, Grunstein RR. Integrating digital behavioural therapy for insomnia into primary care: A feasibility mixed-methods study. J Sleep Res. 2025 Jun;34(3):e14401. doi: 10.1111/jsr.14401. Epub 2024 Nov 12.

  PMID: 39533507 BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Gradisar M, Lack L, Richards H, Harris J, Gallasch J, Boundy M, Johnston A. The Flinders Fatigue Scale: preliminary psychometric properties and clinical sensitivity of a new scale for measuring daytime fatigue associated with insomnia. J Clin Sleep Med. 2007 Dec 15;3(7):722-8.

  PMID: 18198807 BACKGROUND

• Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb;58(2):163-71. doi: 10.1016/j.jpsychores.2004.09.006.

  PMID: 15820844 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.

  PMID: 17339617 BACKGROUND

• Sancho-Domingo C, Carballo JL, Coloma-Carmona A, Buysse DJ. Brief version of the Pittsburgh Sleep Quality Index (B-PSQI) and measurement invariance across gender and age in a population-based sample. Psychol Assess. 2021 Feb;33(2):111-121. doi: 10.1037/pas0000959. Epub 2020 Oct 29.

  PMID: 33119375 BACKGROUND

• Galgut Y, Hoyos C, Kempler L, Aji M, Grunstein RR, Gordon CJ, Bartlett DJ. Cognitive and behavioural therapy for insomnia in the treatment of adolescent insomnia: A systematic review and meta-analysis of randomised controlled trials. J Sleep Res. 2025 Aug;34(4):e14442. doi: 10.1111/jsr.14442. Epub 2024 Dec 16.

  PMID: 39680961 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Professor Delwyn Bartlett

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Galgut, PhD Candidate

CONTACT

+61431333923; yael.galgut@woolcock.org.au

Prof Delwyn Bartlett

CONTACT

delwyn.bartlett@woolcock.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The research staff, e-psychologist and Principle Chief Investigator will not be blinded to the study as they will be managing the online study directly which will lend itself to knowing which groups participants are allocated to. Participants will not be blinded as they will know what treatment they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: February 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share