Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
CompletedNot applicableNCT05846087
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement. 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).
Study details
- Official title
- Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study
- Conditions
- Interventions
- Behavioral: sleep retraining therapy
- Other: sleep health education modules
- Sponsor
- Woolcock Institute of Medical Research
- Collaborators
- Cooperative Research Centre for Alertness, Safety and Productivity; University of Sydney
- Start date
- 2023-09-13
- Primary completion
- 2025-10-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Adults aged ≥ 18 years. 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: 1. Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column. 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;
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05846087