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.
16 -24 years old
Able to give informed online consent and if younger <18years old guardian/parental consent
Insomnia Severity Index ≥ 10
English fluency
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)
Parallel
SleepFix + e-psychologist support calls
BehavioralSleepFix 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
Sleep Health Education (Active control)
BehavioralThree 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.
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.
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.
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).
Effects of the SleepFix intervention on ISI scores
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 compare the ISI in points between the SleepFix intervention group and the Sleep health control group at 6 and 14 Weeks. The investigators will also use baseline value of ISI scores in the model. Both 6 and 14 week comparisons will use a critical P-value of 0.05.
Assessing data completeness: 7-day sleep diaries
To assess data completeness we will calculate the a. Percentage of participants that were randomised and completed their 7-day sleep diary at week 6 and week 14 Completeness of the 7-day sleep diary will be determined by the principal investigator who will individually look at each participant's 7- day sleep diary and make a clinical judgement call whether there is enough data to assess SOL, SE, TST and WASO to be determined complete.
Assessing data completeness: Brief Pittsburgh Sleep Quality Index (B-PSQI)
Description: To assess data completeness by reporting the percentage of completed questionnaires at week 6 and week 14. Specifically, the investigators will evaluate the percentage of participants who were randomised and completed the B-PSQI questionnaire at week 6 and week 14.
Assessing data completeness: The Flinders Fatigue Scale (FFS)
Description: To assess data completeness by reporting the percentage of completed questionnaires at week 6 and week 14. Specifically, the investigators will evaluate the percentage of participants who were randomised and completed the FSS questionnaire at week 6 and week 14.
Number e-psychologist support calls accessed
Participants in the SleepFix treatment group can access an e-psychologist support call each week during the 6 week intervention period. A minimum of 0 and a maximum of 6 e-psychologist support calls can be accessed during the intervention. The investigators will report the number of e-psychologist support calls completed from participants in the SleepFix intervention group. Reporting: this will be reported as a median and IQR.
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Woolcock Institute of Medical Research
Lead sponsor
Macquarie University, Australia
Collaborator
