Evidence map›Paper›PMID 37831493›Full record

Trial reportJMIR mHealth and uHealth2023

App-Based Mindfulness for Attenuation of Subjective and Physiological Stress Reactivity in a Population With Elevated Stress: Randomized Controlled Trial.

Ulrich Kirk, Walter Staiano, Emily Hu, Christelle Ngnoumen, Sarah Kunkle, Emily Shih, Alicia Clausel, Clare Purvis, Lauren Lee

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in JMIR mHealth and uHealth, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05832632 (A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05832632 nacompletednot on this map

A Randomized Controlled Trial Comparing 3 Formats of Mindfulness Interventions to an Active Control Intervention in a Population With Elevated Levels of Stress: Effects of Subjective and Physiological Stress

TypeinterventionalSponsorUniversity of Southern DenmarkRan2021 to 2023Enrolled225ConditionsPsychological Stress, Physiological StressArmsHeadspace Basics Program, Headspace Breathing Exercises, Headspace Stress Program, Active Control (Audiobook)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ulrich KirkDepartment of Psychology, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-2121-2016
Walter Staiano *Department of Psychology, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-1269-0016
Emily HuHeadspace Inc, Santa Monice, CA, United States.ORCID 0000-0002-2299-4072
Christelle NgnoumenHeadspace Inc, Santa Monice, CA, United States.ORCID 0009-0009-7572-8374
Sarah KunkleHeadspace Inc, Santa Monice, CA, United States.ORCID 0000-0002-6368-0205
Emily ShihHeadspace Inc, Santa Monice, CA, United States.ORCID 0000-0001-6761-1832
Alicia ClauselHeadspace Inc, Santa Monice, CA, United States.ORCID 0009-0008-4282-6915
Clare PurvisHeadspace Inc, Santa Monice, CA, United States.ORCID 0009-0004-6422-0886
Lauren LeeHeadspace Inc, Santa Monice, CA, United States.ORCID 0009-0007-6330-0448

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStress-related mental health disorders have steadily increased and contributed to a worldwide disease burden with up to 50% experiencing a stress-related mental health disorder worldwide. Data suggest that only approximately 20%-65% of individuals receive treatment. This gap in receiving treatment may be attributed to barriers such as limited treatment access, negative stigma surrounding mental health treatment, approachability (ie, not having a usual treatment plan or provider), affordability (ie, lack of insurance coverage and high treatment cost), and availability (ie, long waits for appointments) leaving those who need treatment without necessary care. To mitigate the limited access mental health treatment, there has been a rise in the application and study of digital mental health interventions. As such, there is an urgent need and opportunity for effective digital mental health interventions to alleviate stress symptoms, potentially reducing adverse outcomes of stress-related disorders.

objectiveThis study examined if app-based guided mindfulness could improve subjective levels of stress and influence physiological markers of stress reactivity in a population with elevated symptoms of stress.

methodsThe study included 163 participants who had moderate to high perceived stress as assessed by the Perceived Stress Scale (PSS-10). Participants were randomly allocated to 1 of 5 groups: a digital guided program designed to alleviate stress (Managing Stress), a digital mindfulness fundamentals course (Basics), digitally delivered breathing exercises, an active control intervention (Audiobook), and a Waitlist Control group. The 3 formats of mindfulness interventions (Managing Stress, Basics, and Breathing) all had a total duration of 300 minutes spanning 20-30 days. Primary outcome measures were perceived stress using the PSS-10, self-reported sleep quality using the Pittsburgh Sleep Quality Index, and trait mindfulness using the Mindful Attention Awareness Scale. To probe the effects of physiological stress, an acute stress manipulation task was included, specifically the cold pressor task (CPT). Heart rate variability was collected before, during, and after exposure to the CPT and used as a measure of physiological stress.

resultsThe results showed that PSS-10 and Pittsburgh Sleep Quality Index scores for the Managing Stress (all P<.001) and Basics (all P≤.002) groups were significantly reduced between preintervention and postintervention periods, while no significant differences were reported for the other groups. No significant differences among groups were reported for Mindful Attention Awareness Scale (P=.13). The physiological results revealed that the Managing Stress (P<.001) and Basics (P=.01) groups displayed reduced physiological stress reactivity between the preintervention and postintervention periods on the CPT. There were no significant differences reported for the other groups.

conclusionsThese results demonstrate efficacy of app-based mindfulness in a population with moderate to high stress on improving self-reported stress, sleep quality, and physiological measures of stress during an acute stress manipulation task.

trial registrationClinicalTrials.gov NCT05832632; https://www.clinicaltrials.gov/ct2/show/NCT05832632.

Indexed as

MindfulnessMobile ApplicationsAppointments and SchedulesHumansMental HealthStress, PhysiologicalHeadspacemental healthMindfulnessmobile phonesmartphonestresstechnology

Identifiers

PMID37831493
PMCPMC10612013

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.