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

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University of Oxford

Status

Enrolling

Conditions

Anxiety

Treatments

Other: reading about anxiety
Other: intervention with this name in MindEase app

Study type

Interventional

Funder types

Other

Identifiers

NCT05850975
R82884/RE001
https://osf.io/36ukh (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

6,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • anxiety score is above cut-off

Exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

6,200 participants in 14 patient groups, including a placebo group

mindful breathing
Experimental group
Treatment:
Other: intervention with this name in MindEase app
deep breathing
Experimental group
Treatment:
Other: intervention with this name in MindEase app
cognitive therapy
Experimental group
Treatment:
Other: intervention with this name in MindEase app
dare response
Experimental group
Treatment:
Other: intervention with this name in MindEase app
defusion
Experimental group
Treatment:
Other: intervention with this name in MindEase app
in flow with fear
Experimental group
Treatment:
Other: intervention with this name in MindEase app
gratitude practice
Experimental group
Treatment:
Other: intervention with this name in MindEase app
guided mindfulness
Experimental group
Treatment:
Other: intervention with this name in MindEase app
muscle relaxation
Experimental group
Treatment:
Other: intervention with this name in MindEase app
reframe your fears
Experimental group
Treatment:
Other: intervention with this name in MindEase app
calming visualization
Experimental group
Treatment:
Other: intervention with this name in MindEase app
reflective writing
Experimental group
Treatment:
Other: intervention with this name in MindEase app
reading about anxiety
Placebo Comparator group
Treatment:
Other: reading about anxiety
do what you would usually do
No Intervention group

Trial contacts and locations

1

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Central trial contact

Jan M Brauner, MD

Data sourced from clinicaltrials.gov

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