Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia — SleepBack  

Insomnia Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

This study is an online, open-labelled, two-arm, parallel-group randomized controlled trial with embedded internal pilot study of dBTi (SleepFix) versus sleep health education control in adults with chronic low back pain (LBP) and insomnia.

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 = 178) to determine our primary outcomes. We will proceed if:

1. >40% of total sample size (n = 60) are randomized to study arms within 6-months from recruitment start date.

2. 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. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Insomnia
• Low Back Pain
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT05846087
• Study type: Interventional
• Source: Woolcock Institute of Medical Research
• Contact: James M Puterflam, PhD Candidate
• Phone: 0414818290
• Email: james.puterflam@sydney.edu.au
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Completion date: May 31, 2025