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MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial.

Gordon Forbes, Sian Newton, Clara Cantalapiedra Calvete, Judy Birch, Julie Dodds, Liz Steed, Carol Rivas, Khalid S. Khan, Frank Röhricht, Stephanie Taylor, Brennan C Kahan, Elizabeth F. Ball

BMJ Open March 12, 2020 DOI: 10.1136/bmjopen-2019-030164 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomised feasibility trial Randomized Peer reviewed
Sample size 90
Population Women over 18 with organic or non-organic chronic pelvic pain for 6 months or more, recruited at two gynaecology clinics in the UK, with access to a computer or smartphone
Interventions Mindfulness meditation smartphone app usual care without app
Duration 60-day intervention; follow-up at baseline, two, three and 6 months
Measures Pain acceptance scores
Topics Meditation
Keywords Randomised controlled trial Chronic pain Mobile applications Pelvic pain
Registration NCT02721108
Key findings Recruitment and follow-up rates supported feasibility, but adherence to the app interventions was extremely low (mean app use 1.8 days in the mindfulness meditation group and 7.0 days in the active control group). Confidence intervals for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1). The authors conclude a definitive trial of this app is not warranted.

Abstract

To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain. Three arm randomised feasibility trial. Women were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing. Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised. Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days. Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months. The target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were -2.3 (mindfulness meditation vs usual care, 95% CI: -6.6 to 2.0) and -4.0 (mindfulness meditation vs active control, 95% CI: -8.1 to 0.1). Despite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement. NCT02721108; ISRCTN10925965; Results.

Comparable studies

Other randomized controlled trials on meditation, most cited first.

Study Year Design Participants
Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment 2003 Randomized controlled trial n = 41
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults 2008 Randomized controlled trial n = 139
Short-term meditation training improves attention and self-regulation Undergraduate Chinese students 2007 Randomized controlled trial n = 40
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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