Skip to main content
OpenTrials
Completed

NCT Number: NCT04369378

Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LECOM

Erie, Pennsylvania, 16509, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Meditation app usage

Behavioral

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.

Primary outcomes

  1. Anxiety

    Time frame: Immediate post-intervention (compare with pre-intervention data)

    Assessed by survey questions (in part adapted from GAD7)

  2. Well-being

    Time frame: Immediate post-intervention (compare with pre-intervention data)

    Assessed by survey questions (in part adapted from WHO-5)

Secondary outcomes

  1. Future outlook & hopefulness

    Time frame: Immediate post-intervention (compare with pre-intervention data)

    Assessed by survey questions

  2. Sleep habits

    Time frame: Immediate post-intervention (compare with pre-intervention data)

    Assessed by survey questions

  3. Nutrition habits

    Time frame: Immediate post-intervention (compare with pre-intervention data)

    Assessed by survey questions (frequency of consuming whole foods and prepared meals)

  4. Meditation app continued usage

    Time frame: Immediate post-intervention (compare with pre-intervention data)

    Assessed by survey questions (anticipated and actual continued usage of app)

  5. Anxiety

    Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

    Assessed by survey questions (in part adapted from GAD7)

  6. Well-being

    Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

    Assessed by survey questions (in part adapted from WHO-5)

  7. Future outlook & hopefulness

    Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

    Assessed by survey questions

  8. Sleep habits

    Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

    Assessed by survey questions

  9. Nutrition habits

    Time frame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)

    Assessed by survey questions (frequency of consuming whole foods and prepared meals)

  10. Meditation app continued usage

    Time frame: 2 months post-intervention (compare with immediate post-intervention data)

    Assessed by survey questions (anticipated and actual continued usage of app)

Sponsors and collaborators

Lead sponsor

Lake Erie College of Osteopathic Medicine

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2020
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.