Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
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Background: Although there are thousands of mental health apps, 2 apps, Headspace and Calm, claim a large percentage of the marketplace. These two mindfulness and meditation apps have reached tens of millions of active users. To guide consumers, clinicians, and researchers, we performed a systematic review of randomized controlled trials (RCTs) of Headspace and Calm. Objective: Our study aimed to evaluate intervention efficacy, risk of bias, and conflicts of interest (COIs) in the evidence base for Headspace and Calm, the two most popular mental health apps at the time of our search. Methods: To identify studies, we searched academic databases (Google Scholar, MEDLINE, and PsycINFO) and the websites of Headspace and Calm in May 2021 for RCTs of Headspace and Calm testing efficacy via original data collection, published in English in peer-reviewed journals. For each study, we coded (1) study characteristics (eg, participants, sample size, and outcome measures), (2) intervention characteristics (eg, free vs paid version of the app and intended frequency of app usage), (3) all study outcomes, (4) Cochrane risk of bias variables, and (5) COI variables (eg, presence or absence of a preregistration and the presence or absence of a COI statement involving the company). Results: We identified 14 RCTs of Headspace and 1 RCT of Calm. Overall, 93% (13/14) of RCTs of Headspace and 100% (1/1) of RCTs of Calm recruited participants from a nonclinical population. Studies commonly measured mindfulness, well-being, stress, depressive symptoms, and anxiety symptoms. Headspace use improved depression in 75% of studies that evaluated it as an outcome. Findings were mixed for mindfulness, well-being, stress, and anxiety, but at least 40% of studies showed improvement for each of these outcomes. Studies were generally underpowered to detect “small” or “medium” effect sizes. Furthermore, 50% (7/14) of RCTs of Headspace and 0% (0/1) of RCTs of Calm reported a COI that involved Headspace or Calm (the companies). The most common COI was the app company providing premium app access for free for participants, and notably, 14% (2/14) of RCTs of Headspace reported Headspace employee involvement in study design, execution, and data analysis. Only 36% (5/14) of RCTs of Headspace were preregistered, and the 1 RCT of Calm was not preregistered. Conclusions: The empirical research on Headspace appears promising, whereas there is an absence of randomized trials on Calm. Limitations of this study include an inability to compare Headspace and Calm owing to the dearth of RCTs studying Calm and the reliance on author reports to evaluate COIs. When determining whether or not mental health apps are of high quality, identification of high-quality apps and evaluation of their effectiveness and investigators’ COIs should be ensured.
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According to O'Daffer et al., there are 14 randomized controlled trials to date for Headspace, with the majority of participants being non-clinical populations.
“According to O’Daffer et al. [17], there are 14 randomized controlled trials (RCT) to date for Headspace, with the majority of participants being non-clinical populations (Table 3).”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [17]
Headspace studies primarily measured mindfulness, well-being, stress, depressive symptoms, and anxiety symptoms.
“The Headspace studies have an average of 103 participants (except for one RCT with 994 participants [18] and primarily measured mindfulness, well-being, stress, depressive symptoms, and anxiety symptoms.”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [17]
75% of Headspace studies reported improvements in depression.
“75% of the studies reported improvements in depression and the results for other variables such as anxiety symptoms were mixed, but at least 40% of studies showed improvements for each of these outcomes.”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [17]
Most clinical studies of Headspace were not powered to detect small or medium effect sizes, and app adherence was not uniformly measured.
“However, most clinical studies were not powered to detect small or medium effect sizes, and app adherence was not uniformly measured.”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [17]
Four out of the fourteen Headspace studies (29%) did not report adherence data, and three studies (21%) required participants to provide self-reported usage data.
“Four out of the fourteen studies (29%) did not report adherence data, and three studies (21%) required participants to provide self-reported usage data.”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [17]
The results for other variables such as anxiety symptoms were mixed, but at least 40% of Headspace studies showed improvements for each of these outcomes.
“75% of the studies reported improvements in depression and the results for other variables such as anxiety symptoms were mixed, but at least 40% of studies showed improvements for each of these outcomes.”
From A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects (2024) · cites this paper as [17]
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Use of Technology in Brief Interventions
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Introduction to Spirituality and Artificial Intelligence
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- Authors
- O'Daffer, A., Colt, S. F., Wasil, A. R., & Lau, N.
- Affiliations
- University of Pennsylvania (US)
- University of Washington (US)
- Venue
- JMIR Mental Health
- Publisher
- JMIR Publications Inc.
- Published
- 2022-09-20
- Volume
- 9
- Issue
- 9
- Pages
- e40924
- ISSN
- 2368-7959 (ISSN-L)
- PMC
- PMC9533203
- OpenAlex
- W4293397205
- Cited by
- 72
- References
- 45
- Citations by year
- 2026: 7 · 2025: 27 · 2024: 20 · 2023: 18
- FWCI
- 2.88
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Mental Health (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
- Funders
- National Heart, Lung, and Blood Institute (K12HL137940)
- National Cancer Institute (K08CA263474)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- headspace, CALM, mental health apps, mindfulness apps, meditation apps, app efficacy, conflicts of interest, risk of bias, randomized controlled trials, depression, anxiety, stress, well-being, mindfulness, preregistration, underpowered studies, digital mental health interventions, consumer health information
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