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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Other: intervention with this name in MindEase app; Other: reading about anxiety

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 Type: Interventional
• Enrollment (Anticipated): 6200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan M Brauner, MD; Phone Number: 00491779106783; Email: jan.brauner@eng.ox.ac.uk

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX1 3QG
      • Recruiting
      • University of Oxford
      • Contact: Jan M Brauner, MD; Phone Number: 00491779106783; Email: jan.brauner@eng.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• anxiety score is above cut-off

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

14

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Universitätsklinikum Hamburg-Eppendorf; University of Bonn
• Investigators: Principal Investigator: Jan M Brauner, MD, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: April 29, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: depression; anxiety; acceptance and commitment therapy; mindfulness; psychotherapy; randomised controlled trial; cognitive behavioural therapy; app
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: R82884/RE001; https://osf.io/36ukh (Registry Identifier: OSF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous participant data will be accessible to anyone upon request.
• IPD Sharing Time Frame: Immediately after publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No