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Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial

Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05850975
Enrollment
6200
Registered
2023-05-09
Start date
2023-04-11
Completion date
2023-07-31
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, app, psychotherapy, mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, randomised controlled trial, depression

Brief summary

This study investigates the short-term effects of the MindEase app on anxiety levels.

Detailed description

Anxiety is a common symptom in the world's population (Whiteford et al., 2013). It occurs as a symptom within other mental disorders and as a disorder in itself (American Psychiatric Association, 2013). There are several ways of dealing with anxiety, from short guidance for coping on a symptom level to professional health. (Emmelkamp & Ehring, 2014). Many people suffering from anxiety below a threshold indicating need for professional therapy may profit from strategies to calm down. (Helmchen & Linden, 2000). Among the strategies that are effective, there are guided interventions that people can use via a web-based interface on a computer or smartphone (Taylor et al., 2021). While it is known for most interventions that they are helpful, it is often unclear if they work also in web-based environments (Baumel et al., 2020). This is because most research regarding the topic investigates the effectiveness of mental-health apps as a whole, while research of specific interventions is missing (Domhardt et al., 2019). However, to develop effective apps, it is crucial to identify which specific interventions are most efficient in a web-based setting. (Domhardt et al., 2019; Firth et al., 2017). Therefore we want to identify interventions working effectively in an online format. Mind Ease is an app that offers different established interventions within one framework to their users when they feel anxious. This framework makes the different interventions comparable to each other. For this reason, we will test the interventions that are used in the Mind Ease-app. In a first study we will correlate the Mind Ease 3-sliders-score with the state-trait- anxiety-Inventory (SAI). In a second study we will measure participants'; acute anxiety (with the 3-sliders- score) before and after they performed a 10 minutes web-based cognitive or mindfulness-associated intervention. We will compare the anticipated reduction in anxiety to the reduction measured in participants in a control group. Prospectively registered here: https://osf.io/36ukh

Interventions

OTHERintervention with this name in MindEase app

MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.

OTHERreading about anxiety

Participants are given an educational text to read about anxiety.

Sponsors

University of Bonn
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants are not told whether they are in an intervention or control condition. The app is both the care provider and the outcomes assessor. The investigator will be blinded while analysing the data.

Intervention model description

Participants will be randomly assigned to an intervention or control condition.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* anxiety score is above cut-off

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
change in anxiety scoreimmediately before and immediately after the interventionsum of three slider questions on emotional state (3-sliders-score)

Countries

United Kingdom

Contacts

Primary ContactJan M Brauner, MD
jan.brauner@eng.ox.ac.uk00491779106783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026