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

Study Overview
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Brief Summary
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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
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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: >40% of total sample size (n = 60) are randomized to study arms within 3-months from recruitment start date. If <40% of randomized participants fail to complete week 6 end-of-study questionnaires at 4 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.

Official Title
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Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia: a Randomized Controlled Trial With Internal Pilot Study

Conditions
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Chronic Low-back Pain, Insomnia

Intervention / Treatment
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* Behavioral: sleep retraining therapy
* Other: sleep health education modules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open labelled, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* 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.<br>* Other names: sleep consolidation therapy;|
| Active Comparator: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Brief Pain Inventory (BPI) - pain intensity is a subscale of the BPI which is composed of 4-items which ask a rating for current pain, average pain, worst and least pain over the past 24 hours using an 11-point Likert type scales (0 = No pain at all; 10 = worst pain possible). | 24 hours | 
| Insomnia severity index (ISI) | 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from no problem = 0 to severe problem = 4) regarding symptoms over the past 2 weeks. All items are summed with total scores ranging from 0-28. | 2 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) | 19-item self-reported questionnaire which, in this case, assesses sleep quality and disturbances over the previous 2 weeks so only variables across a time-period not including the therapy window are measured. Seven component scores are derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality. | 2 weeks | 
| Pain-related beliefs and attitudes about sleep (PBAS) | The pain-related beliefs and attitudes about sleep questionnaire (PBAS) is a 10-item self-reported measure developed for assessment and treatment of insomnia comorbid with chronic pain. PBAS assesses one's beliefs about the interaction of pain and sleep. Items are measured on an 11-point likert type scale (0 = strongly disagree; 10 = strongly agree). | 1 day | 
| Patient Health Questionnaire-2 (PHQ-2) | The Patient Health Questionnaire-2 is a 2-item self-reported measure of depressive symptoms over the past 2 weeks. Participants are asked to answer questions about the severity of depressive symptoms. Scores for each question (Likert type scale not at all = 0 to nearly every day = 3) sum to a total score of 0 to 6. | 2 weeks | 
| General Anxiety Disorder-7 (GAD-7) | The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety by asking how often participants have experienced symptoms in the previous two weeks. It consists of a three-point Likert type scale for each item (ranging from not at all = 0 to nearly every day = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively. | 2 weeks | 
| EuroQol five-dimensional (EQ-5D) | The EuroQol five-dimensional (EQ-5D) is a well-validated, generic instrument for measuring health related quality of life at the time of completion. The self-reported questionnaire is comprised of 2 components including: (1) Health state description - measured in terms of 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and (2) evaluation - where participants are asked to evaluate their overall health using a visual analogue scale. In Part 1, each item is assigned a level (ranging from indicating no problem1 - indicating unable to/extreme problems - 5) according to the response and this descriptive data is used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, insomnia, digital behavioral therapy for insomnia, sleep retraining therapy, pain interference