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Acceptability of Self-Led Mindfulness-Based Intervention

29 de octubre de 2021 actualizado por: Holly Hazlett-Stevens, University of Nevada, Reno

Mindfulness and Diabetes Distress: Acceptability of Self-Led Mindfulness-Based Intervention

This study had two primary aims. First, the investigators examined the associations between mindfulness and diabetes-related outcomes. It was hypothesized that at baseline, increased mindfulness would be associated with decreased diabetes distress and more optimal glycemic levels and that all three variables would share similar associations with related constructs including greater self-compassion, lower general stress, better psychosocial health, increased diabetes treatment engagement, and greater diabetes-related quality of life. The association between specific aspects of dispositional mindfulness and diabetes distress was also explored. Second, the investigators examined the acceptability, feasibility, and potential utility of self-led MBSR intervention. It was hypothesized that participation in a self-led MBSR intervention would be feasible and acceptable, evidenced by treatment attrition and participant feedback. It was also hypothesized that participants who received the self-led Mindfulness-based stress reduction (MBSR) intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The goal of the present study was to assess the associations of dispositional mindfulness, diabetes distress, and glycemic outcomes for adolescents with type 1 diabetes as well as to use an iterative approach to developing a self-led scalable mindfulness-based intervention. A self-led mindfulness-based intervention may provide a mindfulness practice to help adolescents with type 1 diabetes improve glycemic outcomes through diabetes distress reduction while also being practical within a pediatric endocrinology clinic. A self-led intervention may also reduce the burden associated with mindfulness-based interventions. This is important considering the heightened emotional and time burden adolescents may already experience due to disease management and the intensity of a traditional mindfulness-based intervention.

This study had two primary aims. First, the investigators examined the associations between mindfulness and diabetes-related outcomes. It was hypothesized that at baseline, increased mindfulness would be associated with decreased diabetes distress and more optimal glycemic levels and that all three variables would share similar associations with related constructs including greater self-compassion, lower general stress, better psychosocial health, increased diabetes treatment engagement, and greater diabetes-related quality of life. The association between specific aspects of dispositional mindfulness and diabetes distress was also explored. Second, the investigators examined the acceptability, feasibility, and potential utility of self-led MBSR intervention. It was hypothesized that participation in a self-led MBSR intervention would be feasible and acceptable, evidenced by treatment attrition and participant feedback. It was also hypothesized that participants who received the self-led MBSR intervention would experience increased mindfulness and decreased diabetes distress compared to a waitlist control group.

Tipo de estudio

Intervencionista

Inscripción (Actual)

29

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

  • Estados Unidos
    • Nevada
      • Reno, Nevada, Estados Unidos, 89557
        • University of Nevada, Reno

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

13 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Aged 13-19 years old
  • Type 1 diabetes diagnosis
  • Currently attending school or a recent high school graduate

Exclusion Criteria:

  • Ward of the state
  • Severe psychiatric disturbances (e.g., active psychosis)
  • Severe developmental delay that hindered ability to self-report

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention immediately
The intervention was delivered via a teen MBSR workbook and online communication across the 10-week intervention period. Participants were assigned weekly readings and activities from an MBSR workbook for teens. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention principles and were recommended to be completed daily. Mindfulness-based exercises were either self-led per instructions provided in the workbook or to be completed using an audio recording directing participants' behaviors during the exercise.
Conductual: Mindfulness-Based Stress Reduction
Participants engaged in meditation and self-led exercises to help them understand and cope with stress.
Experimental: Intervention in ten weeks following waitlist
This group received the same intervention as the first arm, however, the participants in arm 2 received the intervention after a 10-week waitlist period. The intervention was delivered via a teen MBSR workbook and online communication across the 10-week intervention period. Participants were assigned weekly readings and activities from an MBSR workbook for teens. Topics included understanding stress, introduction to mindfulness, mindful eating and other mindfulness-based intervention principles and were recommended to be completed daily. Mindfulness-based exercises were either self-led per instructions provided in the workbook or to be completed using an audio recording directing participants' behaviors during the exercise.
Conductual: Mindfulness-Based Stress Reduction
Participants engaged in meditation and self-led exercises to help them understand and cope with stress.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Mindfulness as Assessed by Mindful Attention Awareness Scale-Adolescent (MAAS-A)
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed difference in dispositional mindfulness in adolescents from pre-intervention to post-intervention. The Mindful Attention Awareness Scale-Adolescent has a single-factor structure with 14 items rated on a 6-point scale (1 = almost always, 6 = almost never). Higher scores indicate higher trait mindfulness.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Engagement in Self-Compassionate Behavior as Assessed by Self-Compassion Scale (SCS)
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Participants rated how often they engage in each self-compassionate behavior in specific situations pre- and post-intervention. The Self-Compassion Scale is a 26-item measure rated on a 5-point scale (1 = almost never, 5 = almost always). Higher scores indicate higher self-compassion.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Diabetes Stress as Assessed by Diabetes Stress Questionnaire (DSQ)
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed different daily, diabetes-specific stressors from pre-intervention to post-intervention. The Diabetes Stress Questionnaire consists of 65 items and includes eight subscales. Participants rate severity of stress across several diabetes-related scenarios on a 4-point scale (0 = not at all, 3 = very much). Higher scores indicate higher diabetes distress.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Health-Related Quality of Life as Assessed by Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed diabetes-specific, health-related quality of life in children, adolescents, and young adults from pre-intervention to post-intervention. The Pediatric Quality of Life Inventory 3.2 Diabetes Module consists of 33 items rated on a 5-point scale (0 = never, 4 = almost always). Higher scores indicate greater quality of life.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Perceived Stress as Assessed by Perceived Stress Scale-10 Item Version (PSS-10)
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed the severity of broad, stressful situations in adolescents from pre-intervention to post-intervention. Participants rank how often each statement applies to their feelings of stress on a 5-point scale (0 = never, 4 = very often). Negative items are reversed and the sum of all 10 items is calculated. Higher scores indicate higher perceived stress.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Psychosocial Impairment as Assessed by Pediatric Symptoms Checklist-17 (PSC-17)
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed psychosocial functioning from pre-intervention to post-intervention. Participants rate how frequently each symptom occurs on a 3-point scale (0 = never, 2 = often). Total scores range from 0-34 with higher scores indicating greater risk of psychosocial impairment.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Diabetes Treatment Engagement as Assessed by Self Care Inventory (SCI)
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed to what degree individuals follow health care provider guidelines for diabetes-management behaviors from pre-intervention to post-intervention. The investigators removed the item "how frequently do you come in for appointments" from the study as the measure was not used within a physician/ appointment context. After removing the item, the Self Care Inventory consisted of 22 items and is rated on a 5-point scale (1 = never, 5 = always). Higher scores indicate higher diabetes treatment engagement.
10 weeks intervention, 20 weeks waitlist
Change from Baseline in Glycosylated Hemoglobin Percentage
Periodo de tiempo: 10 weeks intervention, 20 weeks waitlist
Assessed the difference in glycosylated hemoglobin percentage from pre-intervention to post-intervention.
10 weeks intervention, 20 weeks waitlist
Engagement with the Scaled Mindfulness-Based Intervention as Assessed by Number of Weekly Surveys Completed.
Periodo de tiempo: 20 weeks
Assessed the number of weekly surveys each participant completed during the intervention period. Participants were asked to complete at least 6 out of the 10 weekly surveys during the intervention period to be considered highly engaged.
20 weeks
Feasibility of the Scaled Mindfulness-Based Intervention as Assessed by Participant Feedback
Periodo de tiempo: 20 weeks
Assessed the acceptability and feasibility of a mindfulness-based intervention for teens with type 1 diabetes by examining participant feedback on reasons for attrition and low engagement. Weekly feedback surveys asked about barriers to engaging in the weekly material.
20 weeks

Colaboradores e Investigadores

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

Patrocinador

University of Nevada, Reno

Colaboradores

AlterMed Research foundation

Investigadores

  • Investigador principal: Holly Hazlett-Stevens, Ph.D., University of Nevada, Reno
  • Investigador principal: Amy Hughes Lansing, Ph.D., University of Nevada, Reno

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

14 de julio de 2019

Finalización primaria (Actual)

17 de abril de 2020

Finalización del estudio (Actual)

17 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

11 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2021

Publicado por primera vez (Actual)

10 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2021

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

29 de octubre de 2021

Última verificación

1 de octubre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1221205

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Overall analyses and scales can be shared as described in participant consent, however, individual participant data will not be shared.

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. .

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