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

NCT ID: NCT05850975

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2023-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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mindful breathing

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

deep breathing

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

cognitive therapy

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

dare response

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

defusion

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

in flow with fear

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

gratitude practice

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

guided mindfulness

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

muscle relaxation

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

reframe your fears

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

calming visualization

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

reflective writing

Group Type EXPERIMENTAL

intervention with this name in MindEase app

Intervention Type OTHER

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

reading about anxiety

Group Type PLACEBO_COMPARATOR

reading about anxiety

Intervention Type OTHER

Participants are given an educational text to read about anxiety.

do what you would usually do

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intervention 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.

Intervention Type OTHER

reading about anxiety

Participants are given an educational text to read about anxiety.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* anxiety score is above cut-off

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bonn

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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JanBrauner

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan M Brauner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Jan M Brauner, MD

Role: CONTACT

00491779106783

Facility Contacts

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Jan M Brauner, MD

Role: primary

00491779106783

References

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Sandkuhler JF, Kahl F, Sadurska MZ, Brietbart P, Greenberg S, Brauner J. The Immediate Impact of App-Based Psychotherapeutic Exercises on Anxiety: An RCT. Depress Anxiety. 2025 Apr 2;2025:5586831. doi: 10.1155/da/5586831. eCollection 2025.

Reference Type DERIVED
PMID: 40225732 (View on PubMed)

Other Identifiers

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https://osf.io/36ukh

Identifier Type: REGISTRY

Identifier Source: secondary_id

R82884/RE001

Identifier Type: -

Identifier Source: org_study_id

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