Project Movement/Daily Move Feasibility
Testing the Feasibility of Brief Daily App-Based Mindful Movements in US Adults
Přehled studie
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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California
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San Francisco, California, Spojené státy, 94105
- Calm, Inc.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Stress
Časové okno: 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.
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Stress will be measured using the Perceived Stress Scale (PSS).
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Anxiety
Časové okno: 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.
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Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).
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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.
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Depression
Časové okno: 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.
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Depression will be measured using the Hospital Anxiety and Depression Scale (HADS).
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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.
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Mindfulness
Časové okno: 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.
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Mindfulness will be measured using the Mindful Attention Awareness Scale (MAAS).
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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.
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Mood
Časové okno: 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.
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Mood will be measured using the Profile of Mood States (POMS).
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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.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Study Satisfaction
Časové okno: Study satisfaction will be measured at week 8 (post-intervention).
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Study satisfaction will be measured using an investigator-developed satisfaction survey.
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Study satisfaction will be measured at week 8 (post-intervention).
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Calm, Calm.com, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Calm2021-105
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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