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

Sponsor

University of Oxford (Other)

Overall Status

Recruiting

CT.gov ID

NCT05850975

Collaborator

University of Bonn (Other), Universitätsklinikum Hamburg-Eppendorf (Other)

6,200

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

2329.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: intervention with this name in MindEase app Other: reading about anxiety	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mindful breathing	Other: 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.
Experimental: deep breathing	Other: 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.
Experimental: cognitive therapy	Other: 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.
Experimental: dare response	Other: 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.
Experimental: defusion	Other: 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.
Experimental: in flow with fear	Other: 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.
Experimental: gratitude practice	Other: 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.
Experimental: guided mindfulness	Other: 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.
Experimental: muscle relaxation	Other: 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.
Experimental: reframe your fears	Other: 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.
Experimental: calming visualization	Other: 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.
Experimental: reflective writing	Other: 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.
Placebo Comparator: reading about anxiety	Other: reading about anxiety Participants are given an educational text to read about anxiety.
No Intervention: do what you would usually do

Outcome Measures

Primary Outcome Measures

change in anxiety score [immediately before and immediately after the intervention]
sum of three slider questions on emotional state (3-sliders-score)