By Ellen Feldman, MD
Altru Health System, Grand Forks, ND
SYNOPSIS: This randomized trial conducted early in the pandemic with women from an obstetric and gynecologic practice found use of a mobile app promoting mindfulness practice (such as meditation) was associated with a decrease in perceived stress, self-reported anxiety and depression, and sleep disturbance in the intervention group.
SOURCE: Smith RB, Mahnert ND, Foote J, et al. Mindfulness effects in obstetric and gynecology patients during the coronavirus disease 2019 (COVID-19) pandemic. Obstet Gynecol 2021;137:1032-1040.
The medical community responded to the global COVID-19 pandemic with numerous revisions to delivery of care, not the least of which was the postponement of elective surgeries and modifications to routine outpatient appointments.1 Smith et al predicted that these changes could cause significant negative emotional responses in pregnant women and in women with postponed major gynecological surgery. They wondered about the feasibility of an in-home option to prevent or mitigate such a response. To address this, they designed a randomized controlled study that provided Calm, a mobile mindfulness app, to patients randomized into the intervention group.2 Outcomes, including self-reported distress, anxiety, depression, and sleep disturbances, were measured in all participants at baseline, 14 days, and 30 days.
Mindfulness may seem like a trendy term, with publications promoting “The Mindful Teen” and “Mindful Work” offering seemingly limitless possibilities of finding the answers to life’s problems through this technique.3,4 However, the concept of mindfulness dates back to the late 1800s, when the term emerged as an adaptation of a Buddhist concept considered to be on the pathway to enlightenment. About 100 years later, the idea was secularized by molecular biologist and meditator Jon Kabat-Zinn, who defined mindfulness as “the awareness that arises through paying attention on purpose in the present moment, and nonjudgmentally.”5 The Cambridge dictionary expands on this concept, explaining mindfulness as “the practice of being aware of your body, mind, and feelings in the present moment, thought to create a feeling of calm.”6
Medical evidence for the use of mindfulness techniques coexists with a more casual use in lay literature. Limited studies looking at the use of mindfulness to decrease stress and improve decision-making in pregnant patients, patients in the postpartum period, and patients with pelvic pain (pre- and post-surgical) show promise, but there clearly is a need for broader, generalizable data to provide definitive recommendations.5,7 Smith et al noted that one goal of their study was to add to the existing pool of literature regarding the efficacy of mindfulness in addressing negative emotional responses in pregnant women or women with delayed surgical procedures during the COVID pandemic.
After screening 263 women for eligibility criteria (including confirmed pregnancy between 14 and 34 weeks or a delayed surgical procedure due to the pandemic and the ability to use a mobile app), 101 participants were randomized to a “treatment as usual” control group or an active intervention group. Within the intervention group, there were 60 pregnant women and 41 women with delayed procedures. The intervention group was given free access to Calm, a mindfulness app and each member received instruction on how to use the app.2 Recommendations were to use one of the features of Calm at least 70 minutes weekly. Components of Calm include a directed meditation, stories to help with sleep, and soothing sounds of nature.Perceived stress was measured by Cohen’s 10-item Perceived Stress Scale, a widely used, validated tool developed in the 1980s that allows respondents to self-assess degree of stress on a scale from 0 (“never”) to 4 (“almost always”).8 Depression and anxiety were measured with Zigmond’s 14-item Hospital Anxiety and Depression Scale, and sleep disturbance was measured with a short eight-item sleep disturbance questionnaire.9
Table 1 displays the results from the group as a whole at baseline and days 14 and 30. The numbers represent the mean difference (absolute value) between the treatment and control (treatment as usual) groups in each specified category. The two groups had measurements close to the same level at baseline. However, these values separated over time as the treatment group mean value dropped (reflecting a decrease in perceived stress, depression, anxiety, and sleep disturbance).
Table 1. Mean Difference Between Intervention and Control Groups of OB/GYN Patients Using a Mindfulness App |
Time |
Perceived Stress (Cohen’s) |
Depression
(Hospital Anxiety and Depression Scale) |
Anxiety
(Hospital Anxiety
and Depression Scale) |
Sleep Disturbance |
Baseline |
1.68 (95% CI, -0.72 to 4.08); P = 0.17 |
0.17 (95% CI, -1.14 to 1.48); P = 0.81 |
0.71 (95% CI , -1.14 to 2.05); P = 0.43 |
0.68 (95% CI -2.14 to 3.51); P = 0.64 |
Day 14 |
4.27 (95% CI, 1.30 to 7.40); P = 0.005* |
2.27 (95% CI, 0.85 to 3.69); P = 0.002* |
2.65 (95% CI, 0.63 to 4.67); P = 0.01* |
5.40 (95% CI, 2.25 to 8.56); P = 0.001* |
Day 30 |
4.28 (95% CI, 1.68 to 6.88); P = 0.002* |
1.36 (95% CI, 0.04 to 2.68); P = 0.04* |
1.89 (95% CI, 0.06 to 3.72); P = 0.04* |
3.16 (95% CI, 0.44 to 5.88); P = 0.02* |
CI: confidence interval
*Statistically significant value |
COMMENTARY
At first glance, this Smith et al study, with only 101 participants and a relatively short length of follow-up, may seem to offer limited usable clinical material. However, a deeper look uncovers several features worth further discussion and consideration. This investigation was launched during an unprecedented time in modern medicine — the early days of the COVID-19 pandemic. Smith et al noted concerns about the heightened vulnerability of their patient population during this time and should be commended for “thinking on their feet” to develop a protocol for testing a very low-risk, relatively affordable intervention to address potential mental distress in their patients. These preliminary results can springboard further research with more participants and longer follow-up to determine if mindfulness techniques delivered by a mobile app can help mitigate emotional distress during pregnancy and when gynecologic procedures are abruptly canceled or delayed. Future research also should attempt to look at each of these situations individually rather than lumped together, since the efficacy of the app may look different in each. Additionally, a structured comparison of mindfulness apps may be appropriate as well.
Smith et al noted the reasoning for combining the groups was based on the abrupt timing of the emergency declaration, the decision to cancel elective surgeries, and the hope to assist as many patients as possible. Notably, all patients in the control group were given access to the Calm app for 30 days following the termination of the study, but no information regarding this follow-up period was noted in the study. It also is worth commenting that there is no indication from this study that this app (or any app) can or should be used to address a clear psychiatric problem, such as major depressive disorder. None of the scales used to measure the emotional symptoms correlate with a psychiatric diagnosis, but there can be potential to avoid or mitigate severity of major psychiatric problems by monitoring and addressing levels of stress, depression, anxiety, and sleep proactively.10,11
As noted previously, this study was conducted in the early days of the pandemic, and it is unclear if the results are generalizable to more stable times. It is interesting, but not necessarily significant, that the divergence between depression, anxiety, and sleep levels in the intervention group vs. the control group slightly diminished from day 14 to 30 (as seen in Table 1). Lengthier follow-up periods could aid in determining if the connection of app use with enhanced outcomes is sustained or decreases with time. Future investigations also may want to compare results at different timepoints of a pandemic or in a post-pandemic period. In addition, future studies may want to measure how often the app is used on a daily basis to better understand the efficacy of this intervention. In the Smith et al methodology, a weekly use of the app for 70 minutes was recommended, but no information regarding more specific use is reported.
Given the limitations discussed earlier, the results of this study cannot be generalized. However, primary care providers can use this investigation to consider and review innovative methods to assist patients in self-monitoring. Being aware of stress level and the degree of symptoms of depression and anxiety, as well as monitoring sleep, can have a beneficial effect on mental health, especially if a patient is empowered to address some of these items.10,11 While the study gives no generalizable information about what type of individual or what diagnoses benefit most from the Calm app, letting patients know that tools exist to help control and possibly mitigate unwanted emotional responses may be helpful as the provider and patient join together in designing a wellness plan.
REFERENCES
- Czeisler MÉ, Marynak K, Clarke KEN, et al. Delay or avoidance of medical care because of COVID-19-related concerns — United States, June 2020. MMWR Morb Mortal Wkly Rep 2020;69:1260-1257.
- Tee-Melegrito RA. Calm app review: How does it work? Medical News Today. Updated April 8, 2022. https://www.medicalnewstoday.com/articles/calm-app
- Vo DX. The Mindful Teen: Powerful Skills to Help You Handle Stress One Moment at a Time. New Harbinger Publications; 2015.
- Gelles D. Mindful Work: How Meditation Is Changing Business from the Inside Out. HarperOne; 2016.
- Zhang D, Lee E, Mak ECW, et al. Mindfulness-based interventions: An overall review. Br Med Bull 2021;138:41-57.
- Cambridge Dictionary. Mindfulness. https://dictionary.cambridge.org/us/dictionary/english/mindfulness
- Greeson J, Chin G. Mindfulness and physical disease: A concise review. Curr Opin Psychol 2019;28:204-210.
- New Hampshire Department of Administrative Services. Perceived stress scale. https://www.das.nh.gov/wellness/Docs%5CPercieved%20Stress%20Scale.pdf
- Maatoug R, Gorwood P. The psychometrics of the Hospital Anxiety and Depression Scale supports a shorter 12-item version. Psychiatry Res 2019;274-372-376.
- King N, Linden B, Cunningham S, et al. The feasibility and effectiveness of a novel online mental health literacy course in supporting university student mental health: A pilot study. BMC Psychiatry 2022;22:515.
- Bastiaansen JA, Meurs M, Stelwagen R, et al. Self-monitoring and personalized feedback based on the experiencing sampling method as a tool to boost depression treatment: A protocol of a pragmatic randomized controlled trial (ZELF-i). BMC Psychiatry 2018;18:276.
