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

Study Overview
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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 &amp; Ehring, 2014). Many people suffering from anxiety below a threshold indicating need for professional therapy may profit from strategies to calm down. (Helmchen &amp; 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

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

Conditions
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Anxiety

Intervention / Treatment
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* Other: intervention with this name in MindEase app
* Other: reading about anxiety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anxiety score is above cut-off Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to an intervention or control condition.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mindful breathing<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: deep breathing<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: cognitive therapy<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: dare response<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: defusion<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: in flow with fear<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: gratitude practice<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: guided mindfulness<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: muscle relaxation<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: reframe your fears<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: calming visualization<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Experimental: reflective writing<br> | Other: intervention with this name in MindEase app<br>* MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.<br>|
| Placebo Comparator: reading about anxiety<br> | Other: reading about anxiety<br>* Participants are given an educational text to read about anxiety.<br>|
| No Intervention: do what you would usually do<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in anxiety score | sum of three slider questions on emotional state (3-sliders-score) | immediately before and immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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app, anxiety, psychotherapy, mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, randomised controlled trial, depression