Clinical trial NCT04369378: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Well-being
Lead sponsor: Lake Erie College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Anxiety
timeFrame: Immediate post-intervention (compare with pre-intervention data)
measure: Well-being
timeFrame: Immediate post-intervention (compare with pre-intervention data)
Secondary outcomes:
measure: Future outlook & hopefulness
timeFrame: Immediate post-intervention (compare with pre-intervention data)
measure: Sleep habits
timeFrame: Immediate post-intervention (compare with pre-intervention data)
measure: Nutrition habits
timeFrame: Immediate post-intervention (compare with pre-intervention data)
measure: Meditation app continued usage
timeFrame: Immediate post-intervention (compare with pre-intervention data)
measure: Anxiety
timeFrame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
measure: Well-being
timeFrame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
measure: Future outlook & hopefulness
timeFrame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
measure: Sleep habits
timeFrame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
measure: Nutrition habits
timeFrame: 2 months post-intervention (compare with pre-intervention, immediate post-intervention data)
measure: Meditation app continued usage
timeFrame: 2 months post-intervention (compare with immediate post-intervention data)
Other outcomes:
Locations:
city: Erie
country: United States
facility: LECOM
state: Pennsylvania
Study officials:
affiliation: Lake Erie College of Osteopathic Medicine
name: Diana Speelman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.