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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850975
• Other study ID #: R82884/RE001
• Secondary ID: https://osf.io/3
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: July 2023

Study information

• Verified date: April 2023
• Source: University of Oxford
• Contact: Jan M Brauner, MD
• Phone: 00491779106783
• Email: jan.brauner[@]eng.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6200
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• anxiety score is above cut-off Exclusion Criteria: -

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.
• reading about anxiety
Participants are given an educational text to read about anxiety.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Universitätsklinikum Hamburg-Eppendorf, University of Bonn

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in anxiety score	sum of three slider questions on emotional state (3-sliders-score)	immediately before and immediately after the intervention