Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress
11 de abril de 2019 actualizado por: Sharon Gutman, Columbia University
The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance.
This study will use a two group, randomized controlled design in which approximately 25 students will be randomized to an intervention group and 25 to a control group.
Intervention will be implemented in an 8-week period with pre- and post-study measures administered at 1-week prior to and 1-week following intervention.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
College students have reported increasing stress levels in the last 5 years with 1 in 6 students experiencing anxiety levels that adversely impact school function.
This study's intervention uses a variety of media and both online and in-person delivery strategies.
For example, students will have the opportunity to participate in yoga, Tai Chi, guided imagery meditation, creative arts, journaling, and pet therapy.
Students will additionally have the opportunity to participate in activities delivered through online media and accessible at all times throughout the study.
Approximately 50 occupational and physical therapy students will be recruited to participate in this study.
Half will be selected by chance to participate in the 8-week program; the remaining half will be selected by chance to participate in a non-intervention group in which they do not receive the program but are still assessed at pre- and post-program to measure perceived stress levels.
It is anticipated that study results will provide information to educational institutions to help students better manage stress levels.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
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
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University
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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
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Participants will be student volunteers in the Columbia University Physical and Occupational Therapy Programs.
- Students must be in their first or second year, second semester in order to compare GPA pre- and post-intervention.
Exclusion Criteria:
- Students who are practiced meditators or who have prior experience with mindfulness training will be excluded from study participation, as such previous experience could bias intervention results.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Multimodal Mindfulness Activity Program
Students assigned to the intervention will receive 8 weeks of the mindfulness activity intervention.
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This program will provide the opportunity for participants to engage in in-person and online activities. The in-person activities will be held from 12:00 pm to 12:45 pm in the Georgian Physical Therapy Lab (and offered twice per week). The online activities will be available at all times during the study at convenience. There are one 40-minute in-person and four 10-minute online mindfulness activities per week (combined time of 1 hour and 20 minutes per week). In-person activities will consist of mindfulness activities including guided imagery meditation, yoga, Tai Chi, progressive muscle relaxation, creating a Zen garden, aromatherapy, journaling, self-massage, and pet therapy. Online materials will additionally include guided and unguided meditations. |
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Sin intervención: Control Group
Students assigned to the control group will not receive any intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Stress Scale
Periodo de tiempo: 10 minutes
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The Perceived Stress Scale (PSS) is a 10-item, 5-point, self-report Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete.
The scale yields a total score ranging from 0 (no stress) to 50 (highest stress) with scores 25+ indicating a possible stress disorder.
The PSS measures stress level in the last month and was intended for use by community-dwelling adults.
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10 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Student Stress Management Questionnaire
Periodo de tiempo: 10 minutes
|
The Student Stress Management Questionnaire (SSMQ) is a 12-item, 5-point Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete.
The scale yields a total score ranging from 0 (no stress) to 60 (highest stress) with scores 40+ indicating a possible stress disorder.
The SSMQ measures stress level in the last month and was intended for use by college students.
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10 minutes
|
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Daily Log
Periodo de tiempo: 10 minutes
|
The daily log is a 6-item questionnaire that allows students to record the number and length of mindfulness activities in which they participated that day.
Students also report their level of stress before and after participation using a 5-point Likert scale (0 = no stress, 5 = high stress).
Scores of 15+ indicate higher stress levels.
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10 minutes
|
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Grade Point Average (GPA)
Periodo de tiempo: 5 minutes
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GPA will be calculated for the semester prior to and directly after study participation.
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5 minutes
|
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Number of Student Wellness Center Visits
Periodo de tiempo: 5 minutes
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The number of Student Wellness Center visits prior to and directly after study participation will be collected.
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5 minutes
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sharon A Gutman, PhD, Columbia University
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)
1 de febrero de 2019
Finalización primaria (Actual)
11 de abril de 2019
Finalización del estudio (Actual)
11 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
10 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2018
Publicado por primera vez (Actual)
15 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
11 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- AAAS0303
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
producto fabricado y exportado desde los 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. .