Clinical trial NCT05846087: Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Insomnia
Keywords: low back pain
insomnia
digital behavioral therapy for insomnia
sleep retraining therapy
pain interference
Lead sponsor: Woolcock Institute of Medical Research
Sponsor class: OTHER
Collaborators: name: Cooperative Research Centre for Alertness, Safety and Productivity
name: University of Sydney
First posted: 2023-05-06
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open labelled, randomized controlled trial
Primary purpose: TREATMENT

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).

Detailed 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.

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;

Primary outcomes:
measure: Pain interference
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 6 weeks
measure: Insomnia severity index (ISI)
timeFrame: 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 weeks
measure: Pain-related beliefs and attitudes about sleep (PBAS)
timeFrame: 6 weeks
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: 6 weeks
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 6 weeks
measure: EuroQol five-dimensional (EQ-5D)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Woolcock Institute of Medical Research
name: Christopher J Gordon, A/Prof
role: PRINCIPAL_INVESTIGATOR
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