Clinical Trials Directory

Trials / Terminated

TerminatedNCT05248711

Project Movement/Daily Move Feasibility

Testing the Feasibility of Brief Daily App-Based Mindful Movements in US Adults

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
137 (actual)
Sponsor
Calm.com, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to test the feasibility (acceptability and demand) of the Daily Move in a diverse sample of US adults. Acceptability benchmarks: 214 participants recruited within three months (60% will identify as a racial/ethnic minority; 30% African American, 30% Hispanic); At least 70% of participants rate the intervention as satisfactory. Demand benchmarks: At least 70% of participants complete 75% of prescribed Daily Move sessions per week across the 8-weeks; Dropouts not to exceed \>30% of participants. Aim 2 - explore the pre-post trends in change of: Stress - Perceived Stress Scale (PSS), Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS), Mindfulness- Mindful Attention Awareness Scale (MAAS), and Mood- Profile of Mood States (POMS).

Detailed description

Generalized stress among adults is an increasingly problematic concern, particularly in recent years due to the COVID-19 pandemic. According to the Stress in America 2020 data, Americans are still struggling to cope with the disruptions that the pandemic has caused, and nearly 8 in 10 adults (78%) say that the COVID-19 pandemic is a significant source of stress in their life. This stress from the COVID-19 pandemic is in addition to previous sources of stress that impacted American adults, including things such as health care, mass shootings, global climate change, and more. Additionally, rising concerns over racism and racially-driven acts of violence has impacted racial-ethnic minorities and led to rising rates of stress over discrimination. In 2021, 44% of people of color said that discrimination was a significant source of stress in their life, compared with 38% back in 2019. The currently proposed study aims to include American adults with elevated levels of stress, with 60% of the recruited sample targeting racial-ethnic minorities. The investigators have previously conducted multiple feasibility and pilot studies investigating the use of the mobile meditation app, Calm, on various mental health outcomes in a diverse range of adults (cancer patients, adults with sleep disturbances, etc.). The investigators have found the Calm meditation app to be both feasible and beneficial for adults on a range of mental health outcomes, including stress-related outcomes. Although there is a growing body of evidence to describe the benefits of short, daily meditations on stress and other mental health outcomes in adults, there are currently no investigations that have been done to examine the feasibility or impact of short, daily app-based mindful movement exercises on stress in adults. It is for these reasons that the primary purpose of this study is to test the feasibility of the Calm's "Daily Move" component on stressed adults.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCalm Daily MoveThe Daily Move is a series of short, 5-min videos outlining mindful movement exercises. The Daily Move is part of the Calm app's library of content.

Timeline

Start date
2022-01-06
Primary completion
2022-08-01
Completion
2022-08-01
First posted
2022-02-21
Last updated
2022-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05248711. Inclusion in this directory is not an endorsement.