P068 App-delivered sleep therapy for individuals with back pain and insomnia

Abstract Introduction We conducted an online randomized controlled trial with embedded pilot study that investigated the efficacy of a digital behavioural therapy for insomnia (dBTi) for reducing pain interference in people with chronic low back pain (LBP) and insomnia. Methods Participants were recruited via digitally through Meta advertisements and telephone screening. Participants were > 18 years, LBP > 3 months, >10 insomnia severity index (ISI) and smartphone access. The embedded pilot study was conducted during the first 6-months of the trial to evaluate feasibility of recruitment, randomisation and completion. Treatment group received dBTi (SleepFix@) utilising sleep restriction therapy. Control group received education modules about sleep. Primary outcome was pain interference assessed using the brief pain inventory (BPI-PI) at 6 weeks. Secondary outcomes included ISI, sleep quality, pain intensity, and quality of life. NCT05846087. Results After 6 months of recruitment, pre-specified feasibility was demonstrated with 687 screened, 65 randomised, and 48 completers. This allowed the study to continue to the fully powered efficacy phase. We have randomised 91 participants (n = 136 sample size), 71 completed, 5 ongoing, and 15 lost to follow up. Recruitment is ongoing and the full sample size is anticipated within the next two months. Discussion This embedded pilot study demonstrated that recruiting participants with LBP and insomnia using social media is feasible. Clinical trials targeting sleep disturbance are required to investigate new therapeutic approaches to treating LBP with insomnia. The full results of this trial will be presented at the conference.