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Project Movement/Daily Move Feasibility

19 de agosto de 2022 actualizado por: Calm.com, Inc.

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

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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

137

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • San Francisco, California, Estados Unidos, 94105
        • Calm, Inc.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stress
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anxiety
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Study Satisfaction
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Calm, Calm.com, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de enero de 2022

Finalización primaria (Actual)

1 de agosto de 2022

Finalización del estudio (Actual)

1 de agosto de 2022

Fechas de registro del estudio

Enviado por primera vez

19 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

16 de febrero de 2022

Publicado por primera vez (Actual)

21 de febrero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de agosto de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2022

Última verificación

1 de agosto de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Calm2021-105

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Calm Daily Move

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