Mobile app therapy for chronic low back pain and insomnia

Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study

This study is testing if a mobile app that offers therapy for insomnia can help adults with chronic low back pain feel better and sleep more soundly.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 178 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Woolcock Institute of Medical Research (other)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT05846087 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a digital behavioral therapy for insomnia (dBTi) delivered through a mobile app called SleepFix in adults suffering from chronic low back pain and insomnia. Participants will be randomly assigned to either the dBTi intervention or an active control group receiving sleep health education. The study aims to determine if the dBTi can significantly reduce pain-related interference after a 3-week intervention period. Recruitment will occur online, primarily through social media, and the study will be coordinated from the Woolcock Institute of Medical Research in Sydney, Australia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic low back pain and insomnia, who can provide informed consent and use a mobile app.

Not a fit: Patients with serious medical or psychiatric conditions, or those experiencing specific sleep disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel, accessible treatment option for individuals struggling with chronic low back pain and insomnia.

How similar studies have performed: While digital behavioral therapies for insomnia are gaining traction, this specific approach targeting chronic low back pain is relatively novel and has not been extensively tested.

Eligibility criteria

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;

Where this trial is running

Sydney, New South Wales

• Woolcock Institute of Medical Research — Sydney, New South Wales, Australia (RECRUITING)

Study contacts

• Principal investigator: Christopher J Gordon, A/Prof — Woolcock Institute of Medical Research
• Study coordinator: James M Puterflam, PhD Candidate

Conditions: Chronic Low-back Pain, Insomnia, low back pain, insomnia, digital behavioral therapy for insomnia, sleep retraining therapy, pain interference