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

NCT05846087 | Completed DMC

• 1 other identifier: X23-0145
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Low-back Pain; Insomnia

Keywords

low back pain; insomnia; digital behavioral therapy for insomnia; sleep retraining therapy; pain interference

Outcome Measures

Primary Outcomes (1)

• Pain interference

  Brief Pain Inventory (BPI) - pain interference is a subscale of the BPI consisting of 7 items which assess the extent to which pain interferes with: general activity; mood; walking; work (at home or outside); relationships; sleep; and enjoyment of life. BPI items are reported using an 11-point Likert type scale. (0 = "does not interfere"; 10 = "interferes completely"). Responses are summed to provide a global interference score between 0 and 70.

  6 weeks

Secondary Outcomes (7)

• Pain intensity

  6 weeks

• Insomnia severity index (ISI)

  6 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  6 weeks

• Pain-related beliefs and attitudes about sleep (PBAS)

  6 weeks

• Patient Health Questionnaire-2 (PHQ-2)

  6 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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'.

Behavioral: sleep retraining therapy

Control

ACTIVE COMPARATOR

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

Other: sleep health education modules

Interventions

sleep retraining therapy BEHAVIORAL

Sleep retraining therapy improves sleep efficiency (total sleep time/total time in bed) by reducing the amount of time spent in bed awake. The digitally designed version which SleepFix delivers uses an algorithm which requires the users current sleep times and ideal wake-up time to determine when one should get into bed to fall asleep and when one should get out of bed.

Also known as: sleep restriction therapy, sleep consolidation therapy

Treatment

sleep health education modules OTHER

educational modules about sleep and insomnia; its causes; and its impact on various aspects of life. This information is arranged into three modules which will be provided to participants over three weeks.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 1. Female 2. Male 3. Non-binary 4. Prefer not to say
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Sleep disorders (includes: Obstructive Sleep Apnoea, Sleep Behaviour Disorder (i.e sleep talking/walking, REM), Circadian Rhythm Disorder, Restless leg syndrome, Narcolepsy or Bruxism).
• Sleep devices (e.g. CPAP)
• Currently receiving psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
• Professional driver or operate heavy machinery;

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead
• Cooperative Research Centre for Alertness, Safety and Productivity: collaborator
• University of Sydney: collaborator

Study Sites (1)

Woolcock Institute of Medical Research

Sydney, New South Wales, 2037, Australia

Location

Related Publications (24)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Low Back Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher J Gordon, A/Prof

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers responsible for randomization and data-analysis will be blinded to the study arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open labelled, randomized controlled trial

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: September 13, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)