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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369378
• Other study ID #: 27-126
• Status: Completed
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: August 26, 2021

Study information

• Verified date: August 2021
• Source: Lake Erie College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 26, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Well-being

Intervention

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.

Locations

Country	Name	City	State
United States	LECOM	Erie	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lake Erie College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

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