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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Well-being
• Intervention / Treatment: Behavioral: Meditation app usage

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16509
      • LECOM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meditation app group; 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.	Behavioral: Meditation app usage; 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.
No Intervention: Control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Assessed by survey questions (in part adapted from GAD7)	Immediate post-intervention (compare with pre-intervention data)
Well-being	Assessed by survey questions (in part adapted from WHO-5)	Immediate post-intervention (compare with pre-intervention data)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Future outlook & hopefulness	Assessed by survey questions	Immediate post-intervention (compare with pre-intervention data)
Sleep habits	Assessed by survey questions	Immediate post-intervention (compare with pre-intervention data)
Nutrition habits	Assessed by survey questions (frequency of consuming whole foods and prepared meals)	Immediate post-intervention (compare with pre-intervention data)
Meditation app continued usage	Assessed by survey questions (anticipated and actual continued usage of app)	Immediate post-intervention (compare with pre-intervention data)
Anxiety	Assessed by survey questions (in part adapted from GAD7)	2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Well-being	Assessed by survey questions (in part adapted from WHO-5)	2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Future outlook & hopefulness	Assessed by survey questions	2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
Sleep habits	Assessed by survey questions	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)	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)	2 months post-intervention (compare with immediate post-intervention data)

Collaborators and Investigators

• Sponsor: Lake Erie College of Osteopathic Medicine
• Investigators: Principal Investigator: Diana Speelman, PhD, Lake Erie College of Osteopathic Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): August 26, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anxiety Disorders
• Other Study ID Numbers: 27-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No