Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Inso… (NCT05846087) | Clinical Trial Compass
CompletedNot Applicable
Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
Australia106 participantsStarted 2023-09-13
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults aged ≥ 18 years.
✓. Chronic low back pain (pain in lower back region which has been present for 3 months or more).
✓. Able to give informed online consent.
✓. Insomnia Severity Index Score \>10.
✓. English fluency.
✓. Access to a smartphone and willingness/proficiency to use a mobile app for healthcare.
Exclusion criteria
✕. Currently experiencing sciatica or other neuropathic pain condition OR inflammatory condition of the spine/vertebral column.
✕. Shift-workers. Regular work that falls outside the hours between 7am and 6pm.
✕. 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).
✕. Serious medical and/or psychiatric illnesses/disorders (e.g. Major Depressive Disorder, epilepsy, bipolar disorder, heart failure, dementia).