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

Not Applicable

Completed

• Conditions: Well-being; Anxiety

• Registration Number: NCT04369378
• Lead Sponsor: Lake Erie College of Osteopathic Medicine

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).

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Study Start: 2020-08-19
• Primary Completion: 2021-04-28
• Status Verified: 2021-08
• Study Completion: 2021-08-26
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LECOM; 🇺🇸 Erie, Pennsylvania, United States