A feasibility trial of a digital mindfulness-based intervention to improve asthma-related quality of life for primary care patients with asthma

Asthma is a multifaceted chronic disease, with recent estimates that it affects 339 million people of all ages worldwide and 6.5% of the UK population (Bloom et al., 2019). Although evidence suggests that modern pharmacotherapy can achieve good asthma control in clinical trials (Bateman et al., 2004), in reality the heterogenous clinical and behavioral phenotypes mean that asthma outcomes remain suboptimal, and many patients continue to experience persistent symptoms and impaired quality of life (Demoly et al., 2010).

The causes of these suboptimal therapeutic outcomes are complex and wide-ranging, including poor self-management (i.e. corticosteroid inhaler adherence and technique; see Thomas, 2015 for a review). Increasingly the role of psychological comorbidity including anxiety, depression and panic has become apparent (Gada et al., 2014; Goldney et al., 2003; Hasler et al., 2005; Shaw et al., 2015). Anxiety and depression-related psychological dysfunction are up to six times more common in people with an asthma diagnosis (Goodwin et al., 2003; Lavoie et al., 2006), and even more likely with difficult-to-control asthma (Lavoie et al., 2006). With frequent experiences of unpredictable and potentially life-threatening breathlessness, psychological dysfunction is also associated with avoidant coping strategies (leading to lower quality of life; Adams et al., 2004; Cluley & Cochrane, 2001) and increased healthcare utilisation (Richardson et al., 2008). Recent reviews have highlighted the need for appropriate treatment that considers these psychological aspects that will improve patient well-being and asthma control (Baiardini et al., 2015).

Proactive asthma self-management can improve asthma control and reduce healthcare utilisation in a cost-effective manner (Pinnock et al., 2017). As well as promoting appropriate pharmacological management (e.g. regular medication use, maintaining an up-to-date asthma action plan), self-management recommendations for asthma have included non-pharmacological methods such as lifestyle modification, including smoking cessation, weight reduction, breathing retraining (Miles et al., 2017; Bruton et al., 2017). Current research in asthma suggests that psychological interventions that aim to improve asthma-related outcomes can potentially be effective (Yorke et al., 2007). However, evidence for specific treatments generally remains inconclusive due to the low quality and volume of research performed, the variety of interventions investigated (including relaxation, biofeedback, mindfulness and self-management) and the variety of health-related outcome measures reported (Yorke et al., 2015). A recent large-scale randomized controlled trial (RCT) found that self-guided breathing exercises for asthma were effective and cost-effective to improve quality of life (Bruton et al., 2017), and this intervention is now advocated in evidence-based asthma guidelines (James & Lyttle, 2016; Reddel et al., 2015).

Proposed mechanisms behind the purported benefits of non-pharmacological interventions include maladaptive behaviors (such as poor medication adherence or dysfunctional breathing) and cognitive-affective factors (such as inaccurate symptom perception; Janssens et al., 2012), as well as comorbid psychological conditions (such as anxiety and depression). Therefore, psychological interventions that target dysfunctional cognitive-affective mechanisms may benefit asthma quality of life (Janssens et al., 2009).

Mindfulness meditation-based interventions (MBIs), which involve deliberate, non-judgemental attention and acceptance of experiences (Brown & Ryan, 2003), can potentially offer such a benefit for people with asthma. Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) are common treatments for anxiety and depression (Strauss et al., 2014) and have demonstrated benefit across a range of chronic conditions (e.g. fibromyalgia, cancer, arthritis and cardiovascular disease (see Bohlmeijer et al., 2010). Although, as with other non-pharmacological treatments, evidence for asthma-specific benefits is inconclusive (Paudyal et al., 2018), qualitative interviews with patients taking part in mindfulness-based cognitive therapy found improved body awareness and acceptance of symptoms. Cross-sectional studies have found that higher dispositional mindfulness (i.e. an innate capacity to pay attention with a non-judgemental attitude) is associated with reduced asthma symptoms in individuals with poorly controlled asthma (Kraemer & McLeish, 2019) and college students with asthma (Shi et al., 2018). Adults with mild, moderate or severe asthma who were randomized to an 8-week MBSR course (vs. psychoeducation) showed improved quality of life and perceived stress but no improvement in lung function (Pbert et al., 2012).

A common barrier to the implementation of MBIs in chronic disease is the burden of attending the weekly group sessions—for example, a standard MBSR course might consist of 8 two-hour sessions once per week, with additional self-practice (Ainsworth et al., 2020; Simpson et al., 2018). MBIs are complex behavioral interventions and it is therefore possible that they may require innovative delivery models to maximize access and effectiveness across different patient groups and to achieve cost-effectiveness (Demarzo et al., 2015). Digital mindfulness interventions could potentially offer alternatives to traditional programmes, allowing accessibility to content that has been created and validated by experts, across a heterogenous population at low-cost. Digital self-management support interventions have been successfully trialled in asthma, with patient acceptability (Ainsworth et al, 2019a; Morrison et al., 2016). Web-based MBIs have shown some benefit in alleviating symptom burden across non-respiratory chronic conditions (Toivonen et al., 2017), but to date a digital mindfulness intervention has not been evaluated for adults with asthma.

This study aimed to explore the feasibility of using ‘Headspace’, a market-leading digital mindfulness intervention that is commercially available (Mani et al., 2015) for improving patient-reported outcomes for people with mild and moderate asthma treated in primary care, and to estimate effect size for a subsequent fully powered trial.

This pragmatic, randomized feasibility trial shows that the digital mindfulness intervention ‘Headspace’ is relevant and acceptable to at least a proportion of people with asthma, with the potential to benefit patients, so merits a fully-powered confirmatory RCT. Recruitment targets were achieved, randomization procedures were successful, and invitation response and retention rates were comparable with previous randomized controlled trials of digital interventions in similar populations (McLean et al., 2016). Our sample ranged from 18 to 90 years old, demonstrating the potential utility of digital interventions to reach a broad patient demographic. Our questionnaire response rates were in line with previous relevant research (Ainsworth et al., 2019a, 2019b; Morrison et al., 2016) although it should be noted that using both internet and postal measures meant that some patients did not complete all measures (providing valuable information for a future trial).

The remote nature of our trial procedures (with recruitment, enrolment, randomization, intervention and follow-up all occurring online or via post), was efficient and effective as a design. While recruitment rates per practice were slightly lower than in other similar studies (e.g. Ainsworth et al., 2019a, 2019b), the efficient use of resources in remote designs meant we were still able to recruit successfully. Recruitment could be further improved by incorporating additional methods that lend themselves to remote trials, such as social media. There are some drawbacks to remote designs; including the inability to examine such physiological measures as lung function and a reliance on patients to accurately report symptoms and screening criteria. Careful consideration is needed to ensure procedures and interventions do not place patients at risk during remote studies.

Our primary outcomes of interest—asthma quality of life and asthma control—both demonstrated substantial improvement in the intervention group above baseline values, and consistent trends to improvements over the control group. A greater proportion of participants in the intervention group demonstrated an improvement of the minimally important clinical difference in asthma-specific quality of life, with a low number needed to treat of below 5 for a patient to experience a relevant improvement in asthma control. We also observed indications of more positive anxiety and depression scores at follow-up in comparison to the control group.

Although this feasibility study was not powered to evaluate differences between groups, our study consistently found promising indications of improved outcomes for those in the intervention group compared to the control group across almost all patient-reported questionnaires, indicating the potential benefit of the intervention. Importantly, we did not find evidence of change in medication adherence to explain the improvements observed, consistent with the notion that MBTs may act as an adjunct intervention to standard pharmacological treatments to improve quality of life.

One of the strengths of the study was that patient engagement with the Headspace app exceeded other similar digital interventions in primary care patients with asthma (McLean et al., 2016). This suggests that this digital mindfulness intervention may be acceptable and accessible for many people with asthma. However, some participants did not use the intervention at all, suggesting that intervention reach could still be improved, and that this intervention may not be acceptable to all. Of those who did engage, the range of usage was large: some used it once or twice during the entire study whilst others used it several times a day. This is in line with cutting edge theories of digital behavior change interventions: accessible interventions should be flexibly designed to allow for different usage patterns to suit individuals who may engage with behaviors in a variety of different ways that suit them (Ainsworth et al., 2017). In this study, we did not advise how frequently participants should use Headspace, nor if they should access specific components. However, detailed usage data was regarding specific Headspace practices that were preferred by individuals (e.g. ‘Managing Anxiety’ and ‘Stress’) which will inform the development of ‘asthma-specific’ content to improve acceptability and effectiveness in a future trial. For example, initial information provision of potential asthma-related benefits of practicing mindfulness may have led to fewer non-engagers in our study. We also note that the exploratory nature of the feasibility study meant that we did not integrate our data-gathering platform (Lifeguide) with the intervention platform (Headspace) and therefore required participants to sign up to each individually streamlining these for a full trial would likely result in even more effective engagement. We also suggest using theory- and person-based approaches to further maximize acceptability and effectiveness (Yardley et al., 2015). In line with MRC guidance for intervention development and evaluation (Duncan et al., 2020) we have conducted a detailed embedded process that provides further detailed guidance on intervention optimization (Stanescu et al., 2021).

As well as the encouraging results, this study had a sufficient sample size to support confidence in the exploratory findings. While the 2:1 randomization process allows increased variability in the control group, it generated detailed intervention usage data that will inform a further full trial. The online nature of the study meant that study recruitment was particularly cost-effective and facilitated rigid study procedures, with very little possibility for researcher bias or protocol deviation).

There are several limitations to this study which must be acknowledged. Firstly, baseline comparisons indicated that those randomized to the intervention group tended towards impaired quality of life compared to the control group at baseline. Although our primary analysis controlled for these different baseline values, participants in the control group may have experienced a ceiling effect, and consequently had a reduced magnitude of improvement.

Although our findings suggested benefits of the intervention at 6-weeks and 3-months, this study does not explore long-term evidence of benefit (e.g. for over a year). While it is possible that the benefits of mindfulness practice accrue over time, it may be that initial levels of engagement with the digital intervention ‘drop off’ as good habits formed by participants subside. Indeed, the inconsistent and heterogenous nature of asthma symptoms mean that other digital interventions have included specific content to remind users to re-engage when symptoms appear (Ainsworth et al., 2019a) and this should be included in a larger randomized controlled trial.

A complex behavioral intervention such as mindfulness means that participants are not blind to their group allocation. However, psychological benefits to receiving a treatment are, in the case of mindfulness, fundamental treatment components that should be included in evaluation (Ainsworth et al., 2019b) and therefore we consider our pragmatic feasibility trial an effective design, especially given the remote nature of the study (i.e. researcher blinding could not be an issue). Similarly, ‘standard asthma management’ that participants in the control group received may be impacted by enrolment in the study—an issue which should be explored in future research.

Of more concern is the consideration of ‘reach’. Around 4% of eligible patients enrolled in the study, and it is possible that patients with the most impaired quality of life and asthma control (who are likely to benefit most from adjunct therapies) may not be willing (or financially able) to sign up to digital interventions, particularly treatments such as mindfulness. While mindfulness is increasingly common in the public sphere (and therefore increasingly acceptable; (Kachan et al., 2017)), and internet access is more widespread, care must be taken not to entrench digital inequality (Hargittai et al., 2018). Similarly, our sample could have been more diverse; for example, we recruited relatively few non-white participants. Therefore, any further research must use evidence, theory- and person-based approaches to ensure that a full trial and subsequent dissemination is accessible for as inclusive and diverse a demographic as possible.

The remote nature of the study also meant that we were unable to measure objective, physiological markers of asthma, such as lung function and health-resource use. Although evidence suggests that subjective self-report is a more accurate predictor of quality of life (Janssens et al., 2012), such measures should not be overlooked in order to understand the mechanisms by which the observed improvements in asthma control and asthma quality of life occurred. Understanding the mechanisms of psychological and behavioral treatments is important to determine whether the benefits of such treatments are ‘non-specific’ (see Ainsworth et al., 2019b) or target specific psychological mechanisms that may be dysfunctional in patient groups. Mindfulness, which advocates a non-judgemental awareness of thoughts and feelings, may lead to better asthma outcomes through improved symptom perception—which has previously been demonstrated to be a better predictor of quality of life for people with asthma than objective lung function impairment (Janssens et al., 2012). Similarly, mindfulness may improve illness perceptions (beliefs and emotional responses to their condition)—which subsequently effect a range of asthma outcomes including disease management (Kaptein et al., 2010). Although we found potential benefits in disease-specific quality of life, it may be that mindfulness practice leads to a general improvement in mood that, while not specific to asthma, ultimately improves patient quality of life measures that are specifically relevant for asthma evaluation. Further research should complement pragmatic trial studies through experimental studies that detect the degree to which subjective improvement is associated with changes in lung function alongside changes in non-disease-specific subjective outcomes.

This study demonstrated the feasibility of a digital mindfulness intervention for people with asthma in primary care, suggesting benefits for asthma control and quality of life, anxiety and depression. The intervention was acceptable to patients, although engagement levels varied across the sample. With appropriate modification of trial procedures, these data support the feasibility of a confirmatory randomized-controlled trial.