Clinical trial NCT05850975: Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
Official title: Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: anxiety
app
psychotherapy
mindfulness
acceptance and commitment therapy
cognitive behavioural therapy
randomised controlled trial
depression
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University of Bonn
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2023-05-09
Enrollment: 6200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to an intervention or control condition.
Primary purpose: TREATMENT

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

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 \&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

Eligibility criteria: Inclusion Criteria:

* anxiety score is above cut-off

Exclusion Criteria:

-

Primary outcomes:
measure: change in anxiety score
timeFrame: immediately before and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Jan M Brauner, MD
role: PRINCIPAL_INVESTIGATOR
References: