Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
NCT ID: NCT05846087
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2023-09-13
2025-10-30
Brief Summary
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Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).
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Detailed Description
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To be enrolled in the study, participants are required to complete online pre-screening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study. After interview screening, participants will receive an online baseline questionnaire to complete. Once completed, participants will be randomised to one of two study arms. The treatment arm consists of a dBTi intervention using the SleepFix mobile application. The dBTi intervention takes a minimum of 3 weeks to complete with participants allowed to use SleepFix for longer if they wish. Participants randomized to the control arm will be provide sleep health education through email released weekly during the 3-weeks of intervention treatment. Treatment control participants will receive access to SleepFix once end-of-study questionnaire has been completed.
The study will be conducted online via secure platforms with recruitment primarily through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Glebe, NSW, 2037, Australia.
Phase 1 of the study is an internal pilot study which will assess the feasibility of recruitment, data collection and reporting. The following stop-go progression criteria will be used to determine whether we proceed to phase 2 which will continue recruitment until the sample size is reached (n = 134) to determine our primary outcomes. We will:
1. Go if \>40% of total sample size (n = 54) are randomized to study arms within 6-months from recruitment start date.
2. Stop if \>40% of randomized participants fail to complete week 6 end-of-study questionnaires at 6 months from recruitment start date.
Participants who complete the treatment arm of the study will be invited to take part in a post-study interview exploring the user experience of SleepFix and whether it has led to any changes in pain and sleep management. We are conducting these interviews to understand qualitatively how this population feels towards SleepFix and their feelings towards the importance of sleep for their chronic LBP condition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
Three weeks of sleep retraining therapy - behavioral component of cognitive behavioral therapy for insomnia. This will be self-delivered by participants digitally using the smart phone App 'SleepFix'.
sleep retraining therapy
Sleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed.
Control
Sleep health education modules delivered each week for three weeks. Modules contain information about sleep and insomnia; how insomnia affects other aspects of life; what activities influence health sleep (sleep hygiene) and information designed to dispel false beliefs about sleep
sleep health education modules
educational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks.
Interventions
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sleep retraining therapy
Sleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed.
sleep health education modules
educational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic low back pain (pain in lower back region which has been present for 3 months or more).
3. Able to give informed online consent.
4. Insomnia Severity Index Score \>10.
5. English fluency.
6. Access to a smartphone and willingness/proficiency to use a mobile app for healthcare.
Exclusion Criteria
2. Shift-workers. Regular work that falls outside the hours between 7am and 6pm.
3. Trans-meridian travel to a destination with \>2 hours' time-difference (within last 7-days and will subjective reports that they are not experiencing jet lag).
4. Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia).
5. Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism).
6. Sleep devices (e.g. CPAP)
7. Currently receiving psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
8. Professional driver or operate heavy machinery;
18 Years
ALL
No
Sponsors
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Cooperative Research Centre for Alertness, Safety and Productivity
UNKNOWN
University of Sydney
OTHER
Woolcock Institute of Medical Research
OTHER
Responsible Party
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Principal Investigators
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Christopher J Gordon, A/Prof
Role: PRINCIPAL_INVESTIGATOR
Woolcock Institute of Medical Research
Locations
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Woolcock Institute of Medical Research
Sydney, New South Wales, Australia
Countries
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References
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Other Identifiers
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X23-0145
Identifier Type: -
Identifier Source: org_study_id
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