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

NCT04369378 | Completed

• 1 other identifier: 27-126
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Well-being

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Future outlook & hopefulness

  Immediate post-intervention (compare with pre-intervention data)

• Sleep habits

  Immediate post-intervention (compare with pre-intervention data)

• Nutrition habits

  Immediate post-intervention (compare with pre-intervention data)

• Meditation app continued usage

  Immediate post-intervention (compare with pre-intervention data)

• Anxiety

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

Study Arms (2)

Meditation app group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Meditation app group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Lake Erie College of Osteopathic Medicine: lead

Study Sites (1)

LECOM

Erie, Pennsylvania, 16509, United States

Location

Related Publications (1)

• 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.

  PMID: 33298117 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Diana Speelman, PhD

  Lake Erie College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Associate Professor of Biochemistry

Model Details: Randomized controlled trial: adults randomly assigned to daily use of a meditation app for 30 days or control group (no usage of meditation app).

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 30, 2020
• Study Start: August 19, 2020
• Primary Completion: April 28, 2021
• Study Completion: August 26, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of findings
• Access Criteria: Upon written request to corresponding author on publication

Locations

US (1)