The design process and development of MySleepSolutions - A sleep module for a lifestyle self-management app for low back pain

Abstract

Background: Mobile health applications for the management of chronic conditions may be an effective method of supporting self-management. Objective: This report aims to describe the design process of a novel mHealth sleep retraining program for people with low back pain (LBP). Methods: This report includes a detailed description of the design and implementation process which utilized a four-stage framework: (i) concept development, (ii) therapeutic/design approaches, and app features/functionality), (iii) implementation metrics, and (iv) clinical outcomes in end-users. Results: The content of MySleepSolutions which is user-centered, personalized and evidence-based, is grounded in Cognitive Behavior Therapy for Insomnia (CBT-I) techniques and follows best practice guidelines. Conclusions: This detailed description of the design and development of MySleepSolutions ensures the program is comprehensive and has a sound theoretical basis while providing transparency and supporting future research into the development of mHealth retraining programs for sleep disturbance associated with LBP.

Keywords

lifestyle intervention low back pain mHealth self-management sleep

Introduction

Low back pain (LBP) is the leading cause of years lived with disability (YLDs) globally¹ and its prevalence is increasing due to expanding and ageing populations.² In 2020, LBP was estimated to affect 619 million people worldwide² and is projected to increase to over 800 million people by 2050.² LBP is a long-lasting condition with etiology attributed to physical, psychological, and social factors, which are complex and typically difficult to manage.³ Empowering individuals to manage these aspects of their pain and disability will decrease reliance on healthcare systems.^4,5 As the associated disability and costs of LBP increase worldwide,³ the Lancet series on LBP,^3,6,7 a three-part review of the increasing disability associated with LBP globally and suggestions for future LBP care, strongly recommends LBP management focus on the use of self-management strategies.^3,7

Sleep disturbance is commonly associated with chronic illness, leading to poor daytime function, decreased quality of life, and increased use of healthcare.^8,9 Sleep disturbance includes problems such as increased sleep latency, poor quality sleep, frequent night wakings or early morning wakings and poor sleep efficiency.¹⁰ Up to two-thirds of adults who have chronic LBP report sleep disturbance such as difficulty falling asleep, difficulty staying asleep, waking too early, night-time wakefulness or daytime sleepiness and an increase of 1 point in LBP intensity on waking (measured on a 0-10 numeric rating scale [NRS]), has been found to be associated with decreased subsequent sleep quality of 0.5 points (measured on a 0-10 NRS), delayed sleep onset latency of >2 min, and wake after sleep onset of 2 – 6 min.¹¹ While studies suggest a bi-directional relationship between LBP and sleep disturbance,^12,13 research shows that sleep disturbance has greater impacts on LBP coping¹⁴ and pain intensity^15,16 than the opposite relationship. Sleep disturbance has also been shown to mediate the relationship between common mental disorders and LBP.¹⁷

Cognitive Behaviour Therapy for Insomnia (CBT-I), which is the first-line treatment recommendation for insomnia,^18–20 includes behavioural interventions such as sleep hygiene, stimulus control, relaxation, and sleep restriction.¹⁹ These interventions aim to improve sleep drive, sleep-related behaviours, and sleep-related anxiety¹⁹ and have both short-term and long-term benefits for adults with chronic insomnia.²¹ While CBT-I is effective for addressing chronic insomnia and related sleep difficulties, other sleep disorders, such as sleep apnoea or restless legs syndrome may require adjunctive treatments,^22,23 however there is promising evidence for CBT-I improving sleep and pain for individuals with LBP.^24,25

According to the World Health Organization, mHealth interventions (mobile device health interventions)²⁶ are likely to be effective and efficient methods of health promotion due to the widespread use of mobile phones globally.²⁷ MHealth applications (apps) for self-management of LBP,^28–30 chronic pain,^31,32 and sleep³³ have been developed with varying content and efficacy. A recent systematic review found that mHealth apps utilizing multicomponent interventions, such as those that aimed to improve diet, physical activity, and sedentary behavior, are more effective in creating behavior change than stand-alone interventions.³⁴ However, a systematic review of holistic mHealth interventions published in 2023³⁵ acknowledges that the combinations of strategies and interventions that are most effective is unknown and requires further research. Further to this, sleep therapy has rarely been combined with other interventions (such as physical activity or diet) in mHealth apps designed to manage multiple behaviours.³⁶

MySleepSolutions was designed to address this gap in mHealth. It is a 4-week sleep retraining module based on CBT-I principles and has been created as part of the design process of an exercise and lifestyle self-management mHealth app for people with chronic LBP called My Back Exercise. This report aims to describe the design process of the app module, MySleepSolutions, to ensure transparency regarding the theoretical basis and the evidence behind the content.

Methods

The design and development process utilized for MySleepSolutions followed a high-level framework developed by Aji et al.¹⁸ which provides the structure of the design and development, and was informed by the intervention mapping framework³⁷ and the Centre for eHealth research roadmap³⁸ which is an iterative, and cyclic framework.^37,38 To facilitate the development of effective, evidence-based apps for sleep disturbance, the Aji and colleagues’ framework¹⁸ was developed to guide researchers and app developers through the process from app conception to release and evaluation. This framework aims to improve the use of best practice designs, implementation metrics (such as privacy and security concerns as well as validated sleep measures), and appropriate evaluation of efficacy.¹⁸

This framework is divided into four phases. Phase one (concept development), two (therapeutic approach, design approach and app features/functionality), three (implementation metrics, security, and regulations) and four (clinical outcomes in end users). Usability, acceptability, adherence, and engagement analyses are currently underway, as well as a randomized controlled trial (RCT) evaluating the effectiveness of the My Back Exercise app in people with chronic LBP. Ethics approval was attained before testing and evaluation from The University of Sydney Human Research Ethics Committee (2023/772). Therefore, implementation metrics in phase three will be described in detail elsewhere.

The My Back Exercise app is a novel, automated, progressive, self-directed, six-week exercise intervention for people with chronic LBP. It has been designed to harness the benefits of digital and mobile health technology, enabling people with chronic LBP to embrace lifestyle change and self-manage their condition. The app is designed to improve patient-specific function with a dynamic, progressive, goal-oriented exercise program which is based on the users’ responses to the patient-specific functional scale.³⁹ Users are supported by personalized, educational push notifications and optional diet advice as well as the 4-week MySleepSolutions sleep retraining module (Figure 1). The development of the My Back Exercise app will be published following the completion of usability testing.

Figure 1.

MySleepSolutions module in the My Back Exercise App.

Phase one – Concept development

Concept development occurred between October and December 2022. The multidisciplinary team involved in each phase of the development of MySleepSolutions was led by an experienced clinician and PhD student and consisted of 11 researchers, four clinicians, a sleep specialist, and the app developers, all with extensive experience in LBP management, research, or software development. The first meeting occurred in October 2022 and involved discussing the findings of previous work conducted by the research group regarding what consumers deem important for an app designed to improve sleep for people with LBP. This preliminary research employed a nominal group technique in a focus group involving seven musculoskeletal researchers, one clinician, two sleep researchers and one consumer advocate. The nominal group technique involves exploring issues, generating ideas and problem solving in a structed meeting process.⁴⁰ A mixed methods analysis was then conducted to rank the ideas that were generated and offer contextual insights.⁴¹

When designing mHealth apps, a user-centered approach, which addresses the preferences, needs and values of the user, is considered to be the gold standard⁴² to ensure user satisfaction and engagement.⁴³ A design that fails to address the preferences, needs and values of people with LBP,⁴² is unlikely to effectively promote self-management.⁴² For this reason, both people with LBP and clinicians were represented in the detailed data collected during the concept development⁴¹ and planning phase, the iterative process of drafting and designing MySleepSolutions and its subsequent testing and evaluating phases.

Previous research was utilized to further inform the content of the sleep module from the user’s perspective.^44,45 For example, users of mHealth apps for sleep disturbance report valuing audio features, signs of progress and recommendations for helpful websites as well as relevant informative content.⁴⁴ Users of mHealth apps for LBP report valuing knowledge and education, choice regarding engagement with the app, personalization of the content⁴⁶ and clear self-management strategies.²⁹ Expert advice (CG) was provided regarding CBT-I-specific information, as well as app development (CJ). The initial concept was then drafted and edited by the development team at eight subsequent meetings.

Phase two – Therapeutic approach, design approach and app features/functionality

The therapeutic and design approaches, as well as the sleep module features and functionality, were developed over the course of several workshops and regular weekly meetings held between December 2022 and December 2023. The team consisted of the same researchers, clinicians, sleep specialists and app developers who were involved in the concept development and the development of the My Back Exercise app. At each meeting, content was discussed, reviewed, and refined in an iterative process, using sketches, storyboards and mock-ups, to ensure it was evidence based and met the needs of the user. The multidisciplinary team also used these regular meetings to ensure the user experience and user interface design requirements were met by discussing the use of appropriate colors and text, the role of the avatar and the ease of using the app.

Previous literatures reviews were conducted and published by the research group to identify which traditional sleep approaches are effective²⁴ and the feasibility of digital approaches²⁵ for LBP as well as the efficacy of digital CBT.⁴⁷ The first meeting was preceded by a further review of the literature to determine the main objectives of the sleep module content. These objectives were discussed by the development team. KR performed the literature review researching the connection between sleep disturbance and LBP, behavior change theories and taxonomy, as well as a review of existing evidence regarding apps for LBP self-management and sleep retraining. These literature searches aimed to understand user needs and preferences and to collate evidence-based recommendations for sleep retraining. In accordance with the framework for developing an app for sleep disturbance,¹⁸ the content was revised and updated in an iterative, cyclic manner, with weekly meetings and ongoing testing throughout 2023.

The first draft of the content was based on available research,^48–50 Woolcock Institute of Medical Research²⁵ flyers on sleep health in adults, sleep myths and expectations, learning better sleep and relaxation strategies for insomnia,^51–54 the latest research regarding CBT-I^55,56 and expert advice (CG). The content of clinical hints and tips were informed by previous research on consumer preference when receiving text messages for self-managing LBP⁵⁷ and cardiovascular events,⁵⁸ ensuring messages were positively framed, non-authoritarian, socially and culturally appropriate and practical.⁵⁷ App features were designed based on user preferences for sleep apps⁴⁴ and LBP apps,⁵⁹ while also acknowledging that appealing visual features and interactive content assist understanding for users of all levels of health literacy.⁴²

CBT-I is a recommended first-line therapy for insomnia,^18–20 and is highly effective as an mHealth strategy with evidence-based principles.^55,56,60 Based on discussions with sleep research experts and the best available evidence, the components of CBT-I that were included in the 4-week program are: sleep education, sleep hygiene, relaxation training and stimulus control, which are presented in four consecutive weeks.

Sleep restriction is known to be a highly effective component of CBT-I^56,61 and, for this reason, was included in the modules. However, people often find it a challenging therapy due to common side effects such as fatigue and sleepiness.⁵⁶ The development team was concerned that sleep restriction would negatively impact the exercise component of the My Back Exercise app and the score of 80%, rather than 85%, was therefore chosen as the cut-off point (indicating suboptimal sleep efficiency) for directing users to optional sleep restriction tips.

Phase three – Implementation metrics, security, and regulations

Ethics approval has been granted for assessing implementation metrics (i.e., usability, acceptability, engagement, and adherence). These metrics will be assessed using the system usability scale (SUS),⁶² the user version of the Mobile Application Rating Scale (uMARS)⁶³ and a user satisfaction survey. Data security and privacy are important considerations when designing mHealth apps¹⁸ and as such, a privacy policy was developed in consultation with The University of Sydney legal representatives.

Phase four – Clinical outcomes in end users

As MySleepSolutions is designed to support users of the My Back Exercise app, measurement of clinical outcomes will be minimized to decrease survey fatigue among users. Sleep efficiency will be measured using a standard mathematical algorithm. Users are asked about their average hours of sleep per night as well as their average hours spent in bed per night (time awake and time asleep) in the past fortnight, and a percentage is calculated ( $\frac{estimated hours asleep}{total hours in bed} x \frac{100}{1}$ ) to create a sleep efficiency score^44,56 with scores above 80% to 85% considered optimal.⁶⁴ There is some discord regarding the measurement of sleep efficiency,⁶⁵ however, the mathematical equation used in MySleepSolutions is the most common method for measuring sleep efficiency.⁶⁴

Five questions from the Insomnia Severity Index (ISI) were used to measure insomnia severity in the previous fortnight.⁶⁶ The ISI is the gold standard for assessment of insomnia and consists of a 7-item questionnaire which is a reliable (r = 0.74)⁶⁶ and valid tool for measuring insomnia severity in clinical populations and research.⁶⁶ Users rate the severity of sleep disturbance and its impact on daily functioning. Scores for each question are summed, with total scores ranging from 0 to 20 (for the 5 questions used) where higher scores indicate greater levels of insomnia severity.

Results

The design and implementation process utilized for the development of MySleepSolutions, following the Aji and colleagues framework¹⁸ is presented in Figure 2.

Figure 2.

Aji et al Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance adapted for MySleepSolutions.

Phase one – Concept development

The MySleepSolutions program was designed to support individuals with LBP who are using the My Back Exercise app. As users of the My Back Exercise app are likely to face challenges such as engagement with exercise and habit change when committing to their exercise program, MySleepSolutions was designed to be a simple and effective adjunct to the exercise program. For this reason, the sleep module is offered to users but is not compulsory, and assessment and follow-up have been kept to a minimum so as not to over-burden users.

Following this careful planning, Table 1 outlines the core behavior change techniques (BCTs) incorporated into the sleep retraining program, along with the corresponding implementation strategies. These techniques, drawn from established frameworks,^67,68 were selected to address specific challenges in user engagement and adherence,⁶⁹ ensuring the intervention remains both practical and effective. The table also details how resource allocation and potential drawbacks³⁸ were addressed, highlighting the team’s approach to maximizing adoption and ensuring a seamless user experience with the app.¹⁸

Table 1.

Performance objectives, content examples and behavior change techniques utilized in MySleepSolutions.

Performance objectives	Content	Behavior change technique
Users recognize the link between low back pain and poor sleep
Specific education and information provided weekly	E.g. Deep sleep is not the main part of sleep. Most of your night is made up of light sleep so it is normal to rouse lightly then go back to sleep. It is therefore normal to wake overnight but it is not ideal to lie awake for more than 15 min.	Shaping knowledge Natural consequences Associations
Users recognize personal phenotypes related to sleep habits
Users choose the statement that relates most to them each week to direct the weekly content	E.g. You have low back pain, and you have poor sleep, but you did not realize the two could be connected.	Goals and planning Identity Comparison of behavior Personalization Antecedents
Users learn specific cognitive behavior therapy for insomnia (CBT-I) techniques
Users will receive weekly CBT-I based tips and choose the tip they feel they are most able to follow	E.g. Morning sunshine is a really important part of your circadian rhythm which is your sleep/wake cycle. Try to get up at the same time every day and get some morning sunlight – this will help strengthen your circadian rhythms, helping you wake up, and also helping you to sleep better.	Goals and planning Shaping knowledge Repetition
Implement habits to assist sleep hygiene, relaxation, and stimulus control
Implement habits to assist sleep hygiene, relaxation, and stimulus control	In week 2, users will choose a sleep hygiene tip to follow and will receive a daily reminder	Goals and planning Shaping knowledge Natural consequences Associations Repetition Regulation Antecedents Personalization
	In week 3, users will choose a relaxation tip to follow and will receive a daily reminder	Goals and planningShaping knowledgeNatural consequencesAssociationsRepetitionRegulationAntecedentsPersonalization
	In week 4, users will choose a stimulus control tip to follow and will receive a daily reminder	Goals and planningShaping knowledgeNatural consequencesAssociationsRepetitionRegulationAntecedentsPersonalization
Habit formation and motivation	Users will log their daily progress	Goals and planningFeedback and monitoringNatural consequencesComparison of behaviorRewardRegulationSelf-beliefPersonalizationGamification
	Users will be prompted to review their progress at the end of each week	Goals and planningFeedback and monitoringNatural consequencesComparison of behaviorRewardRegulationSelf-beliefPersonalizationGamification
Users can maintain habits to assist sleep improvements in the long term	Users’ sleep will be assessed pre and post program using the Insomnia severity Index (ISI)	Goals and planningFeedback and monitoringPersonalization
	Users’ sleep efficiency will be assessed pre and post program	Goals and planningFeedback and monitoringPersonalization
Implement sleep restriction skills
Where sleep efficiency is less than 80% users will be prompted to choose sleep restriction tips and goals	Users will be guided through basic sleep restriction therapy. E.g. To go to bed when they are tired or to push their bedtime back by 15 min while maintaining their usual waking time.	Goals and planningFeedback and monitoringPersonalization

Phase two - Therapeutic approach

Before commencing the sleep program, the user is asked whether they are interested in learning more about their sleep, how it can impact their LBP and whether they would like to commence the program.

The weekly flow of the program is presented in Figure 3. At the start of each week, the user is presented with four to six phenotypes (Table 2) and is asked to rate how closely each phenotype represents them on a five-point Likert scale. Their weekly program will then be based on the phenotype that most closely represents them. The phenotypes were developed in discussion with clinicians and sleep researchers to engage users with the app content and improve the personalization of their experience. Each phenotype describes, in lay terms, the sleep issues commonly reported by people with LBP, as they relate to the weekly topics, allowing the diversity of sleep issues experienced by people with insomnia⁴⁴ to be included. An example of the weekly phenotypes is presented in Figure 4.

Figure 3.

Example of a weekly program.

Table 2.

Phenotype options presented to users each week to guide program content.

Week	Phenotype options presented to users
Week one: sleep and low back pain
You have low back pain, and you have poor sleep, but you did not realize the two could be connected
Your sleep is fine, but you tend to be a bit of a worrier or over-thinker
Your sleep is not an issue – it is your low back pain that makes it hard to fall asleep and stay asleep
You have low back pain, but you sleep like a log. Your sleep is not a problem – it is when you get up in the morning that you really struggle
Once you fall asleep you sleep well but it can take a while to wind down at night.
Your sleep efficiency is less than 80%
Week two: sleep hygiene
You worry when you go to bed at night that you will wake up with pain during the night
You have a strict routine that you follow to ensure you have a good night sleep. For example, you have a special pillow that you use, you like to have your bed just the right temperature or you …
You have a lot on your mind when you go to sleep at night. You worry a lot and have a busy life, so it is sometimes hard to get everything out of your head when your head hits the pillow
You have trouble falling asleep because it is hard to get comfortable
You wake in the middle of the night (worrying about life or because the kids/pets wake you up) but then when you wake up, you notice your back is sore and have trouble getting back to sleep
You feel stiff and/or sore when you get up in the morning. Sometimes you creep to the bathroom, but you get moving once you have had a warm shower
Week three: Relaxation
You have a busy life with lots to think about. Some days you feel exhausted from dealing with your pain. You know you need to find ways to wind down in the evening before you go to bed, but you just don’t have time
You are pretty wound up at the end of the day and your back is often sore, so you rely on alcohol or other substances to take the edge off before you go to bed
You know how to meditate, and you do it occasionally, but you just can’t get into a regular habit
Meditation holds no appeal to you – there must be something else?
Week four: stimulus control
You are really tired in the evenings but when you get to bed you seem to wake up and then lie there wide awake, wondering what happened to your sleepiness.
You don’t usually have trouble falling asleep, but you wake up several times overnight or you wake up and have trouble falling back to sleep. Once you are awake, you notice your low back pain which might be why it is hard to fall back to sleep.
You have a really strict routine that you feel you have to follow when you go to bed, or you know you will have trouble getting comfortable/ falling asleep.
You like to watch tv to fall asleep at night – it helps to distract you from everything that is on your mind
You like to take your work to bed with you so you can sit up in bed and finish working. But when you put your work away you then lie there wondering why you can’t sleep.

Figure 4.

Examples of the phenotypes presented to the user in week one.

Users will receive an educational tip regarding sleep and/or the sleep-LBP relationship to build an understanding of what constitutes normal sleep patterns in people with and without LBP. They will subsequently be presented with four to six sleep tips that correlate with the phenotype they have selected and will be asked to choose which tip they feel most able to practice that week. This tip is then converted into a daily goal and a short reminder that will be sent as a daily notification to their mobile device. At the end of each day, users can mark off their progress on the progress bar and, at the end of the week, they will be asked to score the effort that they have placed into practicing their daily tip utilizing a simple five-point Likert scale.

The behavior change techniques utilized in the weekly content were based on taxonomy of behavior change techniques proposed by Michie⁶⁷ and expanded by Dugas for mHealth.⁶⁸ Fourteen techniques were utilized and are presented in Table 1. Weekly content was drafted and repeatedly revised by the authors and research team throughout multiple meetings held between October 2022 and October 2023. Reviews ensured lay terms were used, content was kept brief, and hints and tips were evidence-based. In total 21 phenotypes, 21 hints regarding sleep and 85 tips with corresponding goals were designed for the 4-week program.

Design approach

A multidisciplinary, user-centered design approach was utilized reflecting best practices in mHealth app development.¹⁸ Based on the initial interviews with experts and consumers along with the available research,^41,44–46 the following domains were considered important to people with LBP when addressing their sleep: the user experience, personalization of the intervention and assessment-guided management (Table 3). These domains have therefore been considered in depth in the design of MySleepSolutions. The multidisciplinary team worked together to ensure optimal user experience and interface designs that are simple, pleasing to the eye and enjoyable to use.

Table 3.

Design objectives to ensure user-centered content of the sleep module.

User preference	Design strategy
User experience
Informative and relevant content	Ensuring a balance between complexity and simplicity of education/information
Personalized	Do they want it?Do they need it? ISI and sleep efficiency score
Advice and monitoring	Reassess ISI and sleep efficiency at the end of the 4-weeks program
Consumer inclusion in app development	Consumers involved in early development and usability analysis as well as MyBackExercise RCT.
Appealing and user-friendly interface	Ability to choose back pain Doc and voice in the recorded tracks
Audio features	Meditation and breathing tracks
Encouragement – signs of progress	Daily progress bar and weekly personal appraisal
Recommendations for helpful apps and websites	Provided in the educational content of the MyBackExercise app
Able to use off-line	Ensures ease of use and ability to share information with health practitioners
Personalization of the Intervention
Education	Ability to choose own phenotype and tips
Advice on pain relieving modalities	Advice provided in some but not all sleep hints and tips
Advice on mattress, pillow or sleeping position in appropriate	Advice provided in some but not all sleep hints and tips
Individualized BCT
Assessment guided management
Validated sleep and pain questionnaires	ISI and sleep efficiency score
Visualization of data for feedback	Visualization of progress with daily progress bar and weekly personal appraisal
Integration of wearable devices
Track LBP and disability scores	This is provided as part of the main MyBackExercise app
Daily sleep diary
General health screenings	This is provided as part of the main MyBackExercise app

ISI: Insomnia severity index; RCT: randomized control trial; BCT: behavior change techniques; PSQI: Pittsburgh Sleep quality Index

Examples of the design objectives used in the app development based on user preferences to ensure user-centered content of the sleep module.

Personalization is regarded as an important feature in app development to increase user engagement.⁵⁹ For this reason, users are presented with a variety of tips that match the phenotype they select to represent themselves each week. Enabling users to select their preferred tip was intended to support program personalization, bolster the user’s self-efficacy to make the appropriate change, and assist the fit of the app to their needs, all of which, are important to app users.⁵⁹ By selecting the tip to follow, users are also allowed to choose the goal they work towards each week, further improving adherence, engagement,⁷⁰ and motivation.⁷¹

App features and functionality

In line with previous research regarding LBP and self-management strategies,⁴⁵ MySleepSolutions was designed to provide personalized, clear, and consistent advice. Screenshots of the app are displayed in Figure 5 to detail some of the app features and functionality.

Figure 5.

Screenshots of example App content in week one of the module.

At the start of the My Back Exercise app, the user selects an avatar who guides them through their sleep program. The avatar is in important component of the user interface and the user experience and provides personalization and gamification to aid behavior change.⁶⁸ If they choose meditation or breathing exercises, they receive a voice to match their avatar. The avatar (and, therefore, voice recording) can be changed at any stage of the program to suit the user’s preferences.

The daily progress bar and the weekly question, regarding the user’s perception of their use of the tips to improve their sleep, were designed to allow the user to self-assess their effort rather than their sleep. Visual tracking of progress has been found to improve user engagement in the long term⁵⁹ and is a preference of people using sleep apps.⁴⁴

Recent research found that daily use of a mindfulness and meditation app was associated with decreased fatigue, daytime sleepiness, and pre-sleep cognitive arousal in adults with sleep disturbance.⁷² Audio features have also been found to be important in sleep mHealth apps.⁴⁴

Meditation and breathing tracks were therefore recorded by the research team to introduce users to simple meditation and breathing techniques.

Hints and tips were based on readily available literature^{51–53,73–75} and were designed to be short and easy to read. The push notifications were designed to act as reminders to the user to practice their daily tip. They were designed to be short and no more than 90 characters. They were programmed to be sent at appropriate times (i.e., 8pm for an evening practice or 7am for morning practice), as regular reminders have been found to improve user adherence to prescribed activities for managing chronic LBP.⁷⁰ Examples of the sleep education content, sleep tips and daily goals are displayed in Table 4.

Table 4.

Examples of sleep education content, sleep tips and daily goals.

Sleep education content

Did you know that up to 80% of people who have low back pain also have poor sleep? Research suggests that the impact of poor sleep on low back pain is stronger than the opposite, which means that improving your sleep is likely to help your low back pain.

Research tells us that people who have low back pain and people who have trouble falling asleep or staying asleep at night, have something in common - they tend to be worriers. So, whether you are worrying about your back pain or you are worrying about the day you just had, the tendency to worry will make it harder for you to fall asleep and stay asleep.

A drop in core body temperature is one of the most important aspects of falling asleep so cooling down after a warm bath or shower will tell your brain that it is time for sleep.

Sleep tips

The connection between poor sleep and low back pain can actually make your sleep and your pain worse. Research tells us that following tips to improve your sleep will also improve your back pain.

Morning stiffness will often settle with a warm shower or some gentle stretching and just moving around.

Try to get up at the same time every day and get some morning sunlight – this will help strengthen your circadian rhythms, helping you wake up, and also helping you to sleep better.

One of the most powerful tools for improving your sleep is to go to bed when you are tired and not too early. This week, see if you can push your bedtime back a little later so you sleep better during the night. Just make sure to get out of bed at your usual time in the morning.

Mindfulness based stress reduction has been shown to be a fabulous tool for decreasing stress and improving sleep. It may even have a direct effect on how your low back pain affects your day. While it might feel daunting, it is actually a very simple practice to do. In its most basic form, MBSR simply means being in the present or focussing your awareness on the present. You can drink your evening cup of tea mindfully, focussing on how it smells and tastes, you can enjoy a mindful shower, or you can take a slow mindful walk. All are great ways to start practising mindfulness to improve your sleep and your low back pain.

Keep a notepad beside your bed. It can really help to write things down before you go to sleep, so you know you don’t have to worry about them until you wake up again in the morning.

Daily goals

Every night this week you are going to try a ‘worry-less’ strategy before you go to bed. Try one of the meditation or breathing tracks that we recommend or write in a gratitude diary.

This week you are going to focus on keeping a consistent bedtime and awake time routine. Plan to go to bed when you are tired and make sure you get up at the same time every day.

It is important that you try to wake up at the same time every day to help create a strong effective body clock. See if you can wake up at around the same time every day this week (even on the weekend).

Try to get up at the same time every day and get some morning sunlight. Don’t wear sunglasses if you can tolerate the bright sunlight.

Phase three – Implementation metrics, security, and regulations

After extensive testing, the My Back Exercise app has been released and is available for download on the Google Play and Apple App store. The privacy policy has been made publicly available on the My Back Exercise app to ensure transparency of privacy and security protocols such as which health data is collected and where it is stored. Ten experts, stakeholders and consumers will provide important information on the user experience and the user interface via usability, acceptability, adherence, and engagement analyses which are currently underway and will be reported on completion.

Phase four – Clinical outcomes in end-users

The modified version of the ISI and the sleep efficiency calculation have been integrated into the onboarding process of MySleepSolutions^56,65 and are re-calculated at the end of the 4-week program. The sleep efficiency score is used to guide the sleep program, whereas the modified ISI is used to calculate improvement in insomnia following the 4-week program. Where no improvement is seen, or clinical insomnia is still evident, the app provides advice to seek professional help from a sleep specialist or a psychologist.

Discussion

This study aimed to provide a detailed description of the process of designing and building a sleep education module, embedded in a lifestyle self-management app, for people with chronic LBP. It describes the development of MySleepSolutions, utilizing a framework that was created specifically for mHealth apps for sleep disturbance¹⁸ and was informed by the intervention mapping framework³⁷ and the Centre for eHealth research roadmap.³⁸ This detailed description utilizes a best practice design approach ensuring transparency of the design process and the evidence-base behind the content.

MHealth has the potential to improve access to information and improve health self-management globally, but there is a lack of standardization and limited research on the development of these apps.^18,76 Research suggests that available mHealth apps for sleep are variable in quality⁷⁷ and, to the best of our knowledge, no other sleep apps have been developed specifically for people with chronic LBP. Once the planned usability testing and the My Back Exercise randomized controlled trial have been completed, if the sleep module is found to be effective, it could be instrumental for future management of patients with LBP and associated sleep disturbances. Further to this, the transparency provided through this study allows for the reproduction or replication of the app in the future.

Strengths and limitations

The main strength of this study is that the development of the MySleepSolutions sleep module for the My Back Exercise mHealth app followed a best-practice design approach. The development process, which occurred over an 18-month period, used an existing mHealth app framework for sleep disturbance. The cyclic, iterative process involved continual editing, reviewing, testing, and remodeling of the content and the functionality of the program by a multidisciplinary team of users, clinicians, researchers, and developers, some of whom had prior experience in developing mHealth apps. Further, the sound evidence base to the content and the functionality of the program adds to the strengths as well as the evidence supporting the need to include sleep retraining in LBP management.⁷⁸ The clinical evaluation of the sleep program in the form of usability and acceptability testing and a randomized controlled trial, are currently underway. These studies, however, have not yet been finalised, which could be considered a limitation of this study.

Conclusion

This study provides a detailed description of the framework and development process used to create MySleepSolutions, a 4-week sleep module that was created as part of an automated exercise mHealth app designed for people with chronic low LBP. Testing of the module is underway and will be reported accordingly. This study provides a transparent description of the development process, thereby supporting the future development of mHealth apps for self-management of sleep disturbance in people with chronic LBP. Importantly, this module of a unique, multi-component, lifestyle mHealth intervention should be the focus of further research of chronic disease mHealth apps.

What was already known.

• Self-management of LBP is recommended globally. • It is important to recognize and manage sleep issues that are related to chronic LBP. • mHealth apps may be an effective way to support lifestyle change and self-management of LBP.

What this study adds to our knowledge.

• This study provides a detailed report of the concept and design process behind the MySleepSolutions sleep retraining mHealth module allowing for transparency and future app development.

Footnotes

ORCID iDs

Kate Roberts

Anelise Moreti Cabral Silveira

Ethical statement

Authors contributions

KR: conceptualisation, methodology, writing of original draft, review and editing, visualisation. JC: conceptualisation, methodology, app design, review, and editing. JC: conceptualisation, methodology, app design, review, and editing. AMC: conceptualisation, methodology, app design, review, and editing. CMC: conceptualisation, methodology, app design, review, and editing. EH: conceptualisation, methodology, app design, review, and editing. CJ: App design, review, and editing. CG: conceptualisation, methodology, app design, review, and editing. PB: conceptualisation, methodology, app design, supervision, review, and editing. PF: conceptualisation, methodology, app design, supervision, review, and editing. All authors were involved in the concept development and project design. All authors made contributions to the drafted manuscript. All authors read, edited, and approved the final version of the manuscript.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: KR is funded by a University of Sydney LBP research scholarship [APP1180474]. AMCS is funded by a University of Sydney Faculty of Medicine and Health Research Centres Stipend Scholarship and a University of Sydney International Tuition Fee Scholarship.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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