AnxietyNCT05850975
Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
A study testing intervention with this name in MindEase app and reading about anxiety in people with Anxiety, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study investigates the short-term effects of the MindEase app on anxiety levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- intervention with this name in MindEase app and reading about anxiety
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- anxiety score is above cut-off
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, Oxfordshire, OX1 3QG
Jan M Brauner, MD, 00491779106783, jan.brauner@eng.ox.ac.uk
About this study
This study investigates the short-term effects of the MindEase app on anxiety levels.
Read the 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
- Conditions
- Anxiety
- Being tested
- intervention with this name in MindEase app, reading about anxiety
- Keywords
- anxiety, app, psychotherapy, mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, randomised controlled trial, depression
- Medical subject headings
- Anxiety Disorders, Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention with this name in MindEase appOther
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 anxietyOther
Participants are given an educational text to read about anxiety.
| Study group | Role | What they receive |
|---|---|---|
| mindful breathing | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| deep breathing | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| cognitive therapy | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| dare response | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| defusion | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| in flow with fear | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| gratitude practice | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| guided mindfulness | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| muscle relaxation | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| reframe your fears | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| calming visualization | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| reflective writing | Experimental | Not described Receives: Other: intervention with this name in MindEase app |
| reading about anxiety | Placebo comparator | Not described Receives: Other: reading about anxiety |
| do what you would usually do | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in anxiety score
sum of three slider questions on emotional state (3-sliders-score)
Measured: immediately before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start11 Apr 2023
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an intervention or control condition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bonn, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Principal investigator, JanBrauner, University of Oxford
- Investigators
- Jan M Brauner, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850975
- Sponsor's protocol ID
- R82884/RE001
- Other IDs
- https://osf.io/36ukh
- Status last verified
- Apr 2023
- First submitted
- 29 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous participant data will be accessible to anyone upon request.
Publications
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.
PubMed 40225732
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Mind Ease Interventions Reduce Feelings of Acute Anxiety? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05850975
- Acronym / sponsor ID
- R82884/RE001
- Conditions
- Anxiety
- Keywords
- anxiety, app, psychotherapy, mindfulness, acceptance and commitment therapy, cognitive behavioural therapy, randomised controlled trial, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,200 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Bonn, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
- Model description
- Participants will be randomly assigned to an intervention or control condition.
| Arm | Type | Receives |
|---|---|---|
| mindful breathing | Experimental | Other: intervention with this name in MindEase app |
| deep breathing | Experimental | Other: intervention with this name in MindEase app |
| cognitive therapy | Experimental | Other: intervention with this name in MindEase app |
| dare response | Experimental | Other: intervention with this name in MindEase app |
| defusion | Experimental | Other: intervention with this name in MindEase app |
| in flow with fear | Experimental | Other: intervention with this name in MindEase app |
| gratitude practice | Experimental | Other: intervention with this name in MindEase app |
| guided mindfulness | Experimental | Other: intervention with this name in MindEase app |
| muscle relaxation | Experimental | Other: intervention with this name in MindEase app |
| reframe your fears | Experimental | Other: intervention with this name in MindEase app |
| calming visualization | Experimental | Other: intervention with this name in MindEase app |
| reflective writing | Experimental | Other: intervention with this name in MindEase app |
| reading about anxiety | Placebo comparator | Other: reading about anxiety |
| do what you would usually do | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anxiety score is above cut-off
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention with this name in MindEase appMindEase is an app which provides interventions against anxiety. The interventions are based on mindfulness, acceptance and commitment therapy, and cognitive behavioural therapy. | Other | calming visualization, cognitive therapy, dare response, deep breathing, defusion, gratitude practice, guided mindfulness, in flow with fear, mindful breathing, muscle relaxation, reflective writing, reframe your fears |
| reading about anxietyParticipants are given an educational text to read about anxiety. | Other | reading about anxiety |
Primary outcome
change in anxiety score
Time frame: immediately before and immediately after the intervention
sum of three slider questions on emotional state (3-sliders-score)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 40225732Sandkuhler 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.
- Individual participant dataSharing planned: Yes. Anonymous participant data will be accessible to anyone upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan M Brauner, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention with this name in MindEase app and reading about anxiety in people with Anxiety, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan M Brauner, MD (00491779106783, jan.brauner@eng.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in anxiety score (time frame: immediately before and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05850975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.