Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
intervention with this name in MindEase app
reading about anxiety
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring anxiety, app, psychotherapy, mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, randomised controlled trial, depression
Eligibility Criteria
Inclusion Criteria: anxiety score is above cut-off Exclusion Criteria: -
Sites / Locations
- University of OxfordRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
No Intervention
Arm Label
mindful breathing
deep breathing
cognitive therapy
dare response
defusion
in flow with fear
gratitude practice
guided mindfulness
muscle relaxation
reframe your fears
calming visualization
reflective writing
reading about anxiety
do what you would usually do
Arm Description
Outcomes
Primary Outcome Measures
change in anxiety score
sum of three slider questions on emotional state (3-sliders-score)
Secondary Outcome Measures
Full Information
NCT ID
NCT05850975
First Posted
April 29, 2023
Last Updated
April 29, 2023
Sponsor
University of Oxford
Collaborators
University of Bonn, Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT05850975
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oxford
Collaborators
University of Bonn, Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 & 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, app, psychotherapy, mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, randomised controlled trial, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to an intervention or control condition.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
6200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mindful breathing
Arm Type
Experimental
Arm Title
deep breathing
Arm Type
Experimental
Arm Title
cognitive therapy
Arm Type
Experimental
Arm Title
dare response
Arm Type
Experimental
Arm Title
defusion
Arm Type
Experimental
Arm Title
in flow with fear
Arm Type
Experimental
Arm Title
gratitude practice
Arm Type
Experimental
Arm Title
guided mindfulness
Arm Type
Experimental
Arm Title
muscle relaxation
Arm Type
Experimental
Arm Title
reframe your fears
Arm Type
Experimental
Arm Title
calming visualization
Arm Type
Experimental
Arm Title
reflective writing
Arm Type
Experimental
Arm Title
reading about anxiety
Arm Type
Placebo Comparator
Arm Title
do what you would usually do
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
intervention with this name in MindEase app
Intervention Description
MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.
Intervention Type
Other
Intervention Name(s)
reading about anxiety
Intervention Description
Participants are given an educational text to read about anxiety.
Primary Outcome Measure Information:
Title
change in anxiety score
Description
sum of three slider questions on emotional state (3-sliders-score)
Time Frame
immediately before and immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
anxiety score is above cut-off
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan M Brauner, MD
Phone
00491779106783
Email
jan.brauner@eng.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan M Brauner, MD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oxford
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX1 3QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan M Brauner, MD
Phone
00491779106783
Email
jan.brauner@eng.ox.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
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