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Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review

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...

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Autores principales: O'Daffer, Alison, Colt, Susannah F, Wasil, Akash R, Lau, Nancy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9533203/
https://www.ncbi.nlm.nih.gov/pubmed/36125880
http://dx.doi.org/10.2196/40924
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author O'Daffer, Alison
Colt, Susannah F
Wasil, Akash R
Lau, Nancy
author_facet O'Daffer, Alison
Colt, Susannah F
Wasil, Akash R
Lau, Nancy
author_sort O'Daffer, Alison
collection PubMed
description 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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spelling pubmed-95332032022-10-06 Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review O'Daffer, Alison Colt, Susannah F Wasil, Akash R Lau, Nancy JMIR Ment Health Review 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. JMIR Publications 2022-09-20 /pmc/articles/PMC9533203/ /pubmed/36125880 http://dx.doi.org/10.2196/40924 Text en ©Alison O'Daffer, Susannah F Colt, Akash R Wasil, Nancy Lau. Originally published in JMIR Mental Health (https://mental.jmir.org), 20.09.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Mental Health, is properly cited. The complete bibliographic information, a link to the original publication on https://mental.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Review
O'Daffer, Alison
Colt, Susannah F
Wasil, Akash R
Lau, Nancy
Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
title Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
title_full Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
title_fullStr Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
title_full_unstemmed Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
title_short Efficacy and Conflicts of Interest in Randomized Controlled Trials Evaluating Headspace and Calm Apps: Systematic Review
title_sort efficacy and conflicts of interest in randomized controlled trials evaluating headspace and calm apps: systematic review
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9533203/
https://www.ncbi.nlm.nih.gov/pubmed/36125880
http://dx.doi.org/10.2196/40924
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