- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05248711
Project Movement/Daily Move Feasibility
Testing the Feasibility of Brief Daily App-Based Mindful Movements in US Adults
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
California
-
San Francisco, California, Stany Zjednoczone, 94105
- Calm, Inc.
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged 18 years or older
- Score of 6 or greater on the Perceived Stress Scale-4
Exclusion Criteria:
- Subscribe to Calm or use Calm
- Live outside of the United States of America
- Unable to read or understand English
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Daily Move
Participants (n=107) will be provided free access to and asked to register for the consumer-based mobile meditation app, Calm, on their phone.
Participants will then receive an email containing one year of free access to Calm.
Participants will be asked to use the Daily Move component on the Calm app for ~10 minutes per day for 8 weeks.
|
The 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.
|
Brak interwencji: Usual Care
Participants (n=107) will be asked to continue with usual care/routine and complete survey measures at each time point.
Participants will be provided with access to the intervention after their study participation.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Stress
Ramy czasowe: Changes in stress will be measured at baseline, week 2, week 4, week 6, and week 8 (post-intervention). The PSS includes 10 items with total scores ranging from 0-40.
|
Stress will be measured using the Perceived Stress Scale (PSS).
|
Changes in stress will be measured at baseline, week 2, week 4, week 6, and week 8 (post-intervention). The PSS includes 10 items with total scores ranging from 0-40.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Anxiety
Ramy czasowe: Changes in anxiety will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing anxiety symptoms with a total score range of 0-21.
|
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).
|
Changes in anxiety will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing anxiety symptoms with a total score range of 0-21.
|
Depression
Ramy czasowe: Changes in depression will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing depressive symptoms with a total score range of 0-21.
|
Depression will be measured using the Hospital Anxiety and Depression Scale (HADS).
|
Changes in depression will be measured at baseline, week 4, and week 8 (post-intervention). The HADS includes seven items assessing depressive symptoms with a total score range of 0-21.
|
Mindfulness
Ramy czasowe: Changes in mindfulness will be measured at baseline, week 4, and week 8 (post-intervention). The MAAS is a 15-item scale with total possible scores ranging from 15-90, with higher scores indicating greater mindfulness.
|
Mindfulness will be measured using the Mindful Attention Awareness Scale (MAAS).
|
Changes in mindfulness will be measured at baseline, week 4, and week 8 (post-intervention). The MAAS is a 15-item scale with total possible scores ranging from 15-90, with higher scores indicating greater mindfulness.
|
Mood
Ramy czasowe: Changes in mood will be measured at baseline, week 4, and week 8 (post-intervention). The POMS is a 65-item scale with six sub scales. Each item is scored on a 0-4 scale, yielding a total possible score range of -24 to 177.
|
Mood will be measured using the Profile of Mood States (POMS).
|
Changes in mood will be measured at baseline, week 4, and week 8 (post-intervention). The POMS is a 65-item scale with six sub scales. Each item is scored on a 0-4 scale, yielding a total possible score range of -24 to 177.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Study Satisfaction
Ramy czasowe: Study satisfaction will be measured at week 8 (post-intervention).
|
Study satisfaction will be measured using an investigator-developed satisfaction survey.
|
Study satisfaction will be measured at week 8 (post-intervention).
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Calm, Calm.com, Inc.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- Calm2021-105
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Calm Daily Move
-
University of MiamiZakończonyCukrzyca typu 2 i depresja
-
Radicle ScienceZakończony
-
Radicle ScienceZakończony
-
UConn HealthRekrutacyjny
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts...ZakończonyRak piersi | Ocalona od raka piersi | Monitory kondycjiStany Zjednoczone
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)ZakończonyNadwaga i otyłość | Brak aktywności fizycznejStany Zjednoczone
-
Florida International UniversityAndrew Kukes Foundation for Social AnxietyZakończony
-
Stanford UniversityZakończonyLęk społecznyStany Zjednoczone