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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое SleepFix + e-psychologist support calls
  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 effi
• Поведенческое Sleep Health Education (Active control)
  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.

Первичные конечные точки

• 1. Feasibility measure: Trial efficiency data [Срок оценки: Baseline (Week 0)]
• 2. Feasibility measure: Intervention uptake [Срок оценки: 6 weeks]
• Feasibility measure: Data Completion of Insomnia Severity Index [Срок оценки: Week 6 and Week 14]

Вторичные конечные точки (12)

• Effects of the SleepFix intervention on ISI scores [Срок оценки: Week 6 and Week 14]
• Assessing data completeness: 7-day sleep diaries [Срок оценки: Week 6 and week 14]
• Assessing data completeness: Brief Pittsburgh Sleep Quality Index (B-PSQI) [Срок оценки: Week 6 and Week 14]
• Assessing data completeness: The Flinders Fatigue Scale (FFS) [Срок оценки: Week 6 and Week 14]
• Assessing data completeness: Patient Health Questionnaire-2 (PHQ-2) [Срок оценки: Week 6 and Week 14]
• Assessing data completeness: Generalised Anxiety Disorder Scale-2 (GAD-2) [Срок оценки: Week 6 and Week 14]
• Sleep Onset Latency (SOL) [Срок оценки: baseline, week 6 and week 14]
• Wake After Sleep Onset (WASO) [Срок оценки: Baseline, week 6, and week 14]
• Total Sleep Time (TST) [Срок оценки: Baseline, Week 6 and Week 14]
• Sleep Efficiency (SE) [Срок оценки: Baseline, Week 6 and Week 14]
• Brief Pittsburgh Sleep Quality Index (B-PSQI) [Срок оценки: Baseline, Week 6 and Week 14]
• The Flinders Fatigue Scale (FFS) [Срок оценки: Baseline, Week 6 and Week 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07405775 · 2025/ETH19111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗