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
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Woolcock Institute of Medical Research
RECRUITING
Sydney
Contact Information
Primary
James M Puterflam, PhD Candidate
james.puterflam@sydney.edu.au
0414818290
Backup
Christopher J Gordon, A/Prof
christopherjames.gordon@mq.edu.au
0418602816
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 178
Treatments
Experimental: Treatment
Three weeks of sleep retraining therapy - behavioral component of cognitive behavioral therapy for insomnia. This will be self-delivered by participants digitally using the smart phone App 'SleepFix'.
Active_comparator: Control
Sleep health education modules delivered each week for three weeks. Modules contain information about sleep and insomnia; how insomnia affects other aspects of life; what activities influence health sleep (sleep hygiene) and information designed to dispel false beliefs about sleep
Related Therapeutic Areas
Sponsors
Leads: Woolcock Institute of Medical Research
Collaborators: University of Sydney, Cooperative Research Centre for Alertness, Safety and Productivity

This content was sourced from clinicaltrials.gov