- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05248711
Project Movement/Daily Move Feasibility
Testing the Feasibility of Brief Daily App-Based Mindful Movements in US Adults
Descripción general del estudio
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94105
- Calm, Inc.
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
Patrocinador
Investigadores
- Director de estudio: Calm, Calm.com, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
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)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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
-
Radicle ScienceTerminadoEstrés | AnsiedadEstados Unidos
-
University of MiamiTerminadoDiabetes tipo 2 y depresión
-
Radicle ScienceTerminadoEstrés | AnsiedadEstados Unidos
-
University of MontanaReclutamientoEnvejecimientoEstados Unidos
-
UConn HealthReclutamiento
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts...TerminadoCáncer de mama | Sobreviviente de cáncer de mama | Rastreadores de actividad físicaEstados Unidos
-
The University of Texas Health Science Center at...Arizona State UniversityRetirado
-
Birmingham Community Healthcare NHSNSA, LLCTerminado
-
Barron Associates, Inc.Duke University; University of VirginiaReclutamientoRealidad virtual | Terapia ocupacionalEstados Unidos
-
Florida International UniversityAndrew Kukes Foundation for Social AnxietyTerminado