AnxietyNCT04369378
Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic
A study testing Meditation app usage in people with Anxiety and Well-being, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.
Trial summary
This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Well-being
- What is being tested?
- Meditation app usage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 26 Aug 2021
- 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
- Participants must be 18 or older. Inclusion criteria are access to a smartphone and ability to download the mindfulness app, fluency in English, and the ability to complete surveys independently.
Who cannot join
- Exclusion criteria include current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent them from participating.
Trial locations and contacts
1 site in 1 country.
About this study
This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.
Read the detailed description
Question 1: Can 30 days of daily use of a mindfulness app during the Covid-19 pandemic reduce anxiety and improve general well-being and future outlook? Outcomes measured: Pre- and post-intervention surveys to assess well-being and anxiety (primary outcomes), future outlook, hopefulness, and sleep habits (secondary outcomes). Many of these survey questions come from well-validated surveys (WHO-5 Well-being survey, GAD7 Anxiety survey). Post intervention surveys will be administered at the end of the 30d intervention, as well as 2 months after the completion of the 30d intervention.
Question 2: Can 30 days of daily use of a mindfulness app during the Covid-19 pandemic improve nutritional habits? Outcomes measured: Pre- and post-intervention surveys to assess general nutrition habits, including frequency of consuming whole foods (fruits, vegetables, whole grains) and frequency of consuming prepared meals (secondary outcomes). Post intervention surveys will be administered at the end of the 30d intervention, as well as 2 months after the completion of the 30d intervention.
Question 3: Will study participants be more likely to continue to use the mindfulness app after completion of the study? Outcomes measured: Post-intervention survey administered at the end of the 30d intervention will be used to assess likelihood to continue using app and frequency of anticipated continued use. The post-intervention survey administered 2 months after the completion of the 30d intervention will ask if participants continued to use the app, and the frequency of use (secondary outcomes).
- Conditions
- Anxiety, Well-being
- Being tested
- Meditation app usage
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation app usageBehavioural
Investigators will confirm eligibility of applicants, enroll participants in the study and provide an identification number for de-identification of the data, and provide a list of mental health resources to participants. Participants will then be sent a link to a Google Form for the pre-intervention survey, to be completed prior to first use of the mindfulness app. Participants will also be given access to the mindfulness app (Insight Timer), and instructed to use it for 10 min daily for 30 days. Two days before the end of the 30 day intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. Two months after the conclusion of the 30 day intervention period, participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Meditation app group | Experimental | Participants will also be given access to the mindfulness app (Insight Timer), and instructed to use it for 10 min daily for 30 days. Two days before the end of the 30 day intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. Two months after the conclusion of the 30 day intervention period (90 days after study began), participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days. Receives: Behavioral: Meditation app usage |
| Control group | No intervention | Participants will be in the no intervention period for 30 days. Two days before the end of the 30 day no intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. After this 30 day no intervention period, participants are invited to use the Insight Timer app if they so choose. Two months after the conclusion of the 30 day no intervention period (90 days after study began), participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Assessed by survey questions (in part adapted from GAD7)
Measured: Immediate post-intervention (compare with pre-intervention data)
Well-being
Assessed by survey questions (in part adapted from WHO-5)
Measured: Immediate post-intervention (compare with pre-intervention data)
Secondary outcomes (10)
Future outlook & hopefulness
Assessed by survey questions
Measured: Immediate post-intervention (compare with pre-intervention data)
Sleep habits
Assessed by survey questions
Measured: Immediate post-intervention (compare with pre-intervention data)
Nutrition habits
Assessed by survey questions (frequency of consuming whole foods and prepared meals)
Measured: Immediate post-intervention (compare with pre-intervention data)
Meditation app continued usage
Assessed by survey questions (anticipated and actual continued usage of app)
Measured: Immediate post-intervention (compare with pre-intervention data)
Anxiety
Assessed by survey questions (in part adapted from GAD7)
Measured: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Well-being
Assessed by survey questions (in part adapted from WHO-5)
Measured: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Future outlook & hopefulness
Assessed by survey questions
Measured: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Sleep habits
Assessed by survey questions
Measured: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Nutrition habits
Assessed by survey questions (frequency of consuming whole foods and prepared meals)
Measured: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Meditation app continued usage
Assessed by survey questions (anticipated and actual continued usage of app)
Measured: 2 months post-intervention (compare with immediate post-intervention data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start19 Aug 2020
- Primary completion28 Apr 2021
- Study completion26 Aug 2021
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.
- 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
- Randomized controlled trial: adults randomly assigned to daily use of a meditation app for 30 days or control group (no usage of meditation app).
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lake Erie College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Speelman, Lake Erie College of Osteopathic Medicine
- Investigators
- Diana Speelman, PhD, Principal investigator, Lake Erie College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369378
- Sponsor's protocol ID
- 27-126
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be reported as individual data points, as well as means +/- SD or medians with quartiles.
Publications
O'Donnell KT, Dunbar M, Speelman DL. Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Dec 9;21(1):1006. doi: 10.1186/s13063-020-04935-6.
PubMed 33298117
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04369378
- Acronym / sponsor ID
- 27-126
- Conditions
- Anxiety, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Lake Erie College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 30 Apr 2020 (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 interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.
Detailed description
Question 1: Can 30 days of daily use of a mindfulness app during the Covid-19 pandemic reduce anxiety and improve general well-being and future outlook? Outcomes measured: Pre- and post-intervention surveys to assess well-being and anxiety (primary outcomes), future outlook, hopefulness, and sleep habits (secondary outcomes). Many of these survey questions come from well-validated surveys (WHO-5 Well-being survey, GAD7 Anxiety survey). Post intervention surveys will be administered at the end of the 30d intervention, as well as 2 months after the completion of the 30d intervention.
Question 2: Can 30 days of daily use of a mindfulness app during the Covid-19 pandemic improve nutritional habits? Outcomes measured: Pre- and post-intervention surveys to assess general nutrition habits, including frequency of consuming whole foods (fruits, vegetables, whole grains) and frequency of consuming prepared meals (secondary outcomes). Post intervention surveys will be administered at the end of the 30d intervention, as well as 2 months after the completion of the 30d intervention.
Question 3: Will study participants be more likely to continue to use the mindfulness app after completion of the study? Outcomes measured: Post-intervention survey administered at the end of the 30d intervention will be used to assess likelihood to continue using app and frequency of anticipated continued use. The post-intervention survey administered 2 months after the completion of the 30d intervention will ask if participants continued to use the app, and the frequency of use (secondary outcomes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial: adults randomly assigned to daily use of a meditation app for 30 days or control group (no usage of meditation app).
| Arm | Type | Receives |
|---|---|---|
| Meditation app group | Experimental | Behavioral: Meditation app usageParticipants will also be given access to the mindfulness app (Insight Timer), and instructed to use it for 10 min daily for 30 days. Two days before the end of the 30 day intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. Two months after the conclusion of the 30 day intervention period (90 days after study began), participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days. |
| Control group | No intervention | –Participants will be in the no intervention period for 30 days. Two days before the end of the 30 day no intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. After this 30 day no intervention period, participants are invited to use the Insight Timer app if they so choose. Two months after the conclusion of the 30 day no intervention period (90 days after study began), participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be 18 or older. Inclusion criteria are access to a smartphone and ability to download the mindfulness app, fluency in English, and the ability to complete surveys independently.
Key exclusion criteria (1 listed)
- Exclusion criteria include current regular use of a mindfulness or meditation app, regular practice of mindfulness or meditation, regular therapy sessions, inability to complete surveys independently, or any mental health restrictions that would prevent them from participating.
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 |
|---|---|---|
| Meditation app usageInvestigators will confirm eligibility of applicants, enroll participants in the study and provide an identification number for de-identification of the data, and provide a list of mental health resources to participants. Participants will then be sent a link to a Google Form for the pre-intervention survey, to be completed prior to first use of the mindfulness app. Participants will also be given access to the mindfulness app (Insight Timer), and instructed to use it for 10 min daily for 30 days. Two days before the end of the 30 day intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. Two months after the conclusion of the 30 day intervention period, participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days. | Behavioural | Meditation app group |
Primary outcome
Anxiety
Time frame: Immediate post-intervention (compare with pre-intervention data)
Assessed by survey questions (in part adapted from GAD7)
Well-being
Time frame: Immediate post-intervention (compare with pre-intervention data)
Assessed by survey questions (in part adapted from WHO-5)
10 secondary outcomes
Future outlook & hopefulness
Time frame: Immediate post-intervention (compare with pre-intervention data)
Sleep habits
Time frame: Immediate post-intervention (compare with pre-intervention data)
Nutrition habits
Time frame: Immediate post-intervention (compare with pre-intervention data)
Meditation app continued usage
Time frame: Immediate post-intervention (compare with pre-intervention data)
Anxiety
Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Well-being
Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Future outlook & hopefulness
Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Sleep habits
Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Nutrition habits
Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Meditation app continued usage
Time frame: 2 months post-intervention (compare with immediate post-intervention data)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 33298117O'Donnell KT, Dunbar M, Speelman DL. Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Dec 9;21(1):1006. doi: 10.1186/s13063-020-04935-6.
- Individual participant dataSharing planned: Yes. De-identified participant data will be reported as individual data points, as well as means +/- SD or medians with quartiles.
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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.
Diana Speelman, PhD principal investigator
Lake Erie College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation app usage in people with Anxiety and Well-being, run by Lake Erie College of Osteopathic Medicine at 1 site in United States.
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: finished, as of the sponsor's last update on 30 Aug 2021. 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 States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Immediate post-intervention (compare with pre-intervention data)). The study lists 2 primary outcomes in all. 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 NCT04369378, 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 30 Aug 2021.