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

Primary Purpose

Anxiety, Well-being

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation app usage
Sponsored by
Lake Erie College of Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • LECOM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation app group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anxiety
Assessed by survey questions (in part adapted from GAD7)
Well-being
Assessed by survey questions (in part adapted from WHO-5)

Secondary Outcome Measures

Future outlook & hopefulness
Assessed by survey questions
Sleep habits
Assessed by survey questions
Nutrition habits
Assessed by survey questions (frequency of consuming whole foods and prepared meals)
Meditation app continued usage
Assessed by survey questions (anticipated and actual continued usage of app)
Anxiety
Assessed by survey questions (in part adapted from GAD7)
Well-being
Assessed by survey questions (in part adapted from WHO-5)
Future outlook & hopefulness
Assessed by survey questions
Sleep habits
Assessed by survey questions
Nutrition habits
Assessed by survey questions (frequency of consuming whole foods and prepared meals)
Meditation app continued usage
Assessed by survey questions (anticipated and actual continued usage of app)

Full Information

First Posted
April 24, 2020
Last Updated
August 27, 2021
Sponsor
Lake Erie College of Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04369378
Brief Title
Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic
Official Title
Effectiveness of Using a Meditation App in Reducing Anxiety and Improving Well-being During the Covid-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lake Erie College of Osteopathic Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation app group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Meditation app usage
Intervention Description
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 Outcome Measure Information:
Title
Anxiety
Description
Assessed by survey questions (in part adapted from GAD7)
Time Frame
Immediate post-intervention (compare with pre-intervention data)
Title
Well-being
Description
Assessed by survey questions (in part adapted from WHO-5)
Time Frame
Immediate post-intervention (compare with pre-intervention data)
Secondary Outcome Measure Information:
Title
Future outlook & hopefulness
Description
Assessed by survey questions
Time Frame
Immediate post-intervention (compare with pre-intervention data)
Title
Sleep habits
Description
Assessed by survey questions
Time Frame
Immediate post-intervention (compare with pre-intervention data)
Title
Nutrition habits
Description
Assessed by survey questions (frequency of consuming whole foods and prepared meals)
Time Frame
Immediate post-intervention (compare with pre-intervention data)
Title
Meditation app continued usage
Description
Assessed by survey questions (anticipated and actual continued usage of app)
Time Frame
Immediate post-intervention (compare with pre-intervention data)
Title
Anxiety
Description
Assessed by survey questions (in part adapted from GAD7)
Time Frame
2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Title
Well-being
Description
Assessed by survey questions (in part adapted from WHO-5)
Time Frame
2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Title
Future outlook & hopefulness
Description
Assessed by survey questions
Time Frame
2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Title
Sleep habits
Description
Assessed by survey questions
Time Frame
2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Title
Nutrition habits
Description
Assessed by survey questions (frequency of consuming whole foods and prepared meals)
Time Frame
2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Title
Meditation app continued usage
Description
Assessed by survey questions (anticipated and actual continued usage of app)
Time Frame
2 months post-intervention (compare with immediate post-intervention data)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Speelman, PhD
Organizational Affiliation
Lake Erie College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
LECOM
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16509
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data will be reported as individual data points, as well as means +/- SD or medians with quartiles.
IPD Sharing Time Frame
Upon publication of findings
IPD Sharing Access Criteria
Upon written request to corresponding author on publication
Citations:
PubMed Identifier
33298117
Citation
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.
Results Reference
derived

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

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