Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
2 other identifiers
interventional
6,200
1 country
1
Brief Summary
This study investigates the short-term effects of the MindEase app on anxiety levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Apr 2023
Shorter than P25 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2023
CompletedFirst Submitted
Initial submission to the registry
April 29, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMay 9, 2023
April 1, 2023
3 months
April 29, 2023
April 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in anxiety score
sum of three slider questions on emotional state (3-sliders-score)
immediately before and immediately after the intervention
Study Arms (14)
mindful breathing
EXPERIMENTALdeep breathing
EXPERIMENTALcognitive therapy
EXPERIMENTALdare response
EXPERIMENTALdefusion
EXPERIMENTALin flow with fear
EXPERIMENTALgratitude practice
EXPERIMENTALguided mindfulness
EXPERIMENTALmuscle relaxation
EXPERIMENTALreframe your fears
EXPERIMENTALcalming visualization
EXPERIMENTALreflective writing
EXPERIMENTALreading about anxiety
PLACEBO COMPARATORdo what you would usually do
NO INTERVENTIONInterventions
MindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy.
Participants are given an educational text to read about anxiety.
Eligibility Criteria
You may qualify if:
- anxiety score is above cut-off
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- University of Bonncollaborator
- Universitätsklinikum Hamburg-Eppendorfcollaborator
Study Sites (1)
University of Oxford
Oxford, Oxfordshire, OX1 3QG, United Kingdom
Related Publications (1)
Sandkuhler JF, Kahl F, Sadurska MZ, Brietbart P, Greenberg S, Brauner J. The Immediate Impact of App-Based Psychotherapeutic Exercises on Anxiety: An RCT. Depress Anxiety. 2025 Apr 2;2025:5586831. doi: 10.1155/da/5586831. eCollection 2025.
PMID: 40225732DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan M Brauner, MD
University of Oxford
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- medical doctor
Study Record Dates
First Submitted
April 29, 2023
First Posted
May 9, 2023
Study Start
April 11, 2023
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
May 9, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Immediately after publication. No end date.
- Access Criteria
- Anyone who wishes to access the data.
Anonymous participant data will be accessible to anyone upon request.