Improvements in Stress, Affect, and Irritability Following Brief Use of a Mindfulness-based Smartphone App: A Randomized Controlled Trial – Economides et al, 2018

Available here – full text.

One area which I reviewed as part of my foundation module in pain was Mindfulness and Mindfulness-Based Stress Reduction (MBSR) to see if there was any benefit for chronic pain sufferers. From what I found in a number of papers I reviewed was that pain scores do not change but acceptance of chronic pain improves.  Since reading about this, it is something I have mentioned to my patients as an option, or at least to investigate it.  I always add the caveat ‘it is not for everyone’ but a surprising number of the young soldiers I see with pain (usually musculoskeletal or urological) engage with it.  I reviewed one paper which looked specifically at Headspace (as one of the smartphone app market leaders).  This was an RCT of Head Space, where patients were randomised to either the app or active control, to see if Head Space was superior (Economides et al., 2018).  My non-expert critical ‘take’ on the paper is summarised below. This study used validated outcome measures which demonstrated statistically improved scores in measures of irritability & anxiety.

Aim / Type of study An RCT comparing Mindfulness to an active control.

 

Methods A 3rd party recruiting agency (https://www.findparticipants.com) was used to recruit participants. They did NOT have chronic pain and were naïve to both meditation, mindfulness and the Headspace app. They had no psychological illness.  They had to have access to a smartphone. Using a statistical approach, 52 participants were required to achieve significance at the 0.05% level.

The Headspace meditation mindfulness app was compared against a control group using Headspace audiobook. The intervention group (N=41) was exposed to the first 10 sessions of 10-minute sessions delivered by the Headspace app.  The control (N=28) was 10 sessions of 10 minutes of excerpts from a Mindfulness & Meditation audiobook.  To closely match the intervention, the audiobook was narrated by the same author in a similar manner.  Thus, the only difference between the two groups was the content.

There were 4 outcome measures:  Stress Overload Scale (SOS) – personal vulnerability and event load, Scale of Positive and Negative Experience (SPANE) and Brief Irritability Test (BITe).  These were assessed by all participants in both groups and paired T-tests were undertaken between them. Dropouts were included in an intention to treat analysis.

The outcome measures were all reductions in the 4 measures from baseline.  The reduction in scores in the two groups were assessed by an Analysis of Variance test (ANOVA) as well as post hoc t-tests to further characterise differences.  Intention to treat analysis was also included.

Results / Data In two of the outcome measures (SOS event load and SPANE) there was significant difference between the groups favouring Head Space (P<=0.01).  SOS personal vulnerability was also different between the groups again favouring Head Space (P=<=0.05). There was no difference in the SOS Personal Vulnerability score between the two groups (P=0.09).
Comments Whilst the size of the groups was different (41 in Headspace vs 28 in Audiobook), they were broadly similar demographically.  There were more females in the Headspace group and the percentage who agreed or strongly agreed meditation could be beneficial was higher (70.8% vs 57.2%), although the authors comment that demographics were not significantly different (x2 test >0.05).  After randomisation and allocation but before baseline assessment, a much higher number of audiobook participants dropped out (48 vs 33) resulting in a smaller group.

The outcome measures were scores on validated questionnaires with good internal consistency.  All the tests have good test re-test reliability bar the BITe which has not been determined yet.  The participants were randomised by a rigorous approach and blinded to the intervention they were receiving but it is difficult to ascertain if the reviewers were blinded.  The study was all done on-line and were e-mailed the voucher code which restricted their access to the intervention or control content.  By assumption, this is a single-blinded study as the researcher would have known who was receiving the code.

In terms of the strengths and weaknesses of the study, two of the researchers were involved in the development of the Head Space app.  The possibility of funding bias is raised by this given a potential conflict of interest with a commercial product.  There are three other areas for critical review in the context of the population researched:

Area of Reflection Implication for chronic pain patients
The patients involved did not have chronic pain. The findings of this study may not be generalisable.
The sample may not represent the general population.  In both groups, those who agreed or strongly agreed meditation can be beneficial is over 50% (29/41 and 16/28 for Head Space and control respectively).  This compares to a large survey which found a lifetime prevalence of 5.2% of the use of meditation for health reasons (Cramer et al., 2016). Patients who have previously done well with psychoeducational pain courses (ie an acceptance of MBSR) may well do better with Mindfulness.
The demographics of the sample cohort are predominantly white/Caucasian and college/university education.  All three of these reduce the applicability of this study to the wider population, a valid point raised by the researchers when assessing the strengths/weakness of their work. Again the generalisability may be challenged.  The Army has a mixed ethnic demography but is still predominantly Caucasian.  Future work I am considering is to see if commonwealth soldiers with chronic pain can get similar benefits.

To summarise, MBSR can improve affect and reduce depression scores but may not significantly reduce pain scores. It can be delivered successfully via a smartphone app. It is a low-risk intervention which may have some positive benefits.  This paper is a small snapshot with some methodological weaknesses, but it otherwise seems well constructed and I liked the active control.  To the uninitiated who had not used MBSR before, it seems like a good comparator.  It has certainly prompted some discussion amongst our primary care team about the role of apps in the rehabilitation of our injured soldiers.  We hope to look at two or three of these (including Headspace) in this context and get both objective results as well as the qualitative opinion of what the soldier actually thought.

CRAMER, H., HALL, H., LEACH, M., FRAWLEY, J., ZHANG, Y., LEUNG, B., ADAMS, J. & LAUCHE, R. 2016. Prevalence, patterns, and predictors of meditation use among US adults: a nationally representative survey. Scientific reports,6,36760.

ECONOMIDES, M., MARTMAN, J., BELL, M. J. & SANDERSON, B. 2018. Improvements in Stress, Affect, and Irritability Following Brief Use of a Mindfulness-based Smartphone App: A Randomized Controlled Trial.Mindfulness,1-10.

 

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