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(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)

18 de septiembre de 2017 actualizado por: Radboud University Medical Center

(Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).

Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.

Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .

Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).

We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

245

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

  • Países Bajos
    • Gelderland
      • Nijmegen, Gelderland, Países Bajos, 6500HB
        • Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
    • Utrecht
      • Bilthoven, Utrecht, Países Bajos, 3723 MB
        • Helen Dowling Institute

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

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • HADS ≥ 11
  • Cancer diagnosis (at present or past)
  • Stable dose if using psychopharmacological medication for at least 3 months
  • computer literacy and acces to internet
  • capable of filling out questionnaires in Dutch

Exclusion Criteria:

  • severe psychiatric morbidity as psychoses, suicidal ideation
  • previous mindfulness-based treatment.

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 de un solo grupo
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Online MBCT
Conductual: Mindfulness Based Cognitive Therapy
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
Experimental: group MBCT
Conductual: Mindfulness Based Cognitive Therapy
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
Sin intervención: Treatment as usual
3 months waiting list, subsequent assignment to group or online MBCT

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in anxiety and depressive symptoms
Periodo de tiempo: 0 (baseline), 3 months (post intervention)
Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS). The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms. The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002). This instrument was also validated in a palliative cancer population (Akechi, 2006).
0 (baseline), 3 months (post intervention)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in fear of cancer recurrence
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI; Simard & Savard, 2009a; van der Lee et al., 2012).
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
DSM-IV Axis I mood or anxiety disorders
Periodo de tiempo: 0, 3 (post intervention), 12 months (9mo follow-up)
DSM IV Axis I psychiatric disorder as diagnosed by a structured interview
0, 3 (post intervention), 12 months (9mo follow-up)
Change from baseline in positive mental health
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
The Mental Health Continuum-Short Form (MHC-SF) measures positive mental health and comprises 14 items, representing various feelings of well-being. Respondents rate the frequency of every feeling in the past month on a 6-point Likert scale (never, once or twice a month, about once a week, two or three times a week, almost every day, every day). The MHC-SF contains three subscales: emotional, psychological and social well-being. MHC-SF has shown high internal and moderate test-retest reliability, convergent and discriminant validity.
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in healthcare consumption
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
The TIC-P generates quantitative data about direct medical costs and indirect societal costs as a consequence of psychological/psychiatric illnesses.
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
To measure the quality of the health status of cancer patients a validated health-related quality of life (HRQoL) instrument will be used, the EuroQol-5D (EQ-5D). This HRQoL instrument will be completed by the patient together with a researcher and is available in a validated Dutch translation (Lamers, 2005). The EQ-5D is a generic HRQoL instrument comprising five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D index is obtained by applying predetermined weights to the five domains. This index gives a societal-based global quantification of the participant's health status on a scale ranging from 0 (death) to 1 (perfect health). Participants will also be asked to rate their overall HRQoL on a visual analogue scale (EQ- 5D VAS) consisting of a vertical line ranging from 0 (worst imaginable health status) to 100 (best imaginable).
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
In addition to the EQ-5D, the SF-12 will be administered for explorative purposes for there are indications that the SF-12 is more sensitive for changes in HRQol in populations with less severe morbidity (Johnson and Coons, 1998).
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in mindfulness skills
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
The 39-item Five Facet Mindfulness Questionnaire has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness. A Dutch 24-item short form of the FFMQ (FFMQ-SF) was developed and assessed in a sample of 376 adults with clinically relevant symptoms of depression and anxiety and cross-validated in an independent sample of patients with fibromyalgia. Confirmatory factor analyses showed good model fit for the five-factor structure of the FFMQ-SF: observing, describing, acting with awareness, nonjudging, and nonreactivity. The FFMQ-SF was related to measures of psychological symptoms, well-being, experiential avoidance, and the personality factors neuroticism and openness to experience.
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in rumination
Periodo de tiempo: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
The rumination subscale of the RRQ assesses a neurotic self-attentiveness (i.e. recurrent, primarily past-oriented thinking about the self), which is prompted by threats, losses, of injustices to the self. Subjects rate their level of agreement of disagreement on a five-point rating scale (e.g., "I always seem to be rehashing in my mind recent things I've said or done"). There is evidence of good internal consistency (.90) and stability over a 10-month period and convergent validity. The measure in the current study was translated into Dutch using the guidelines of the International Test Commission (Hambleton, 1994). Cronbach's alphas were .88 and .90 in Sample 1, and .90 and .91 in Sample 2, respectively (Luyckx et al., 2008).
0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in personality assessment
Periodo de tiempo: 0 (baseline) and 12 months (9mo follow-up)
Personality is measured with the NEO Five Factor Inventory (NEO-FFI, Costa & McCrae, 1992) which consists of five domains: neuroticism, extraversion, openness, altruism, and conscientiousness.
0 (baseline) and 12 months (9mo follow-up)
Change in mindfulness skills during intervention
Periodo de tiempo: week 2,3,4,5,6,7,8 and 9 of intervention
The Mindful Attention Awareness Scale (MAAS) will be administered before each MBCT session to assess mindful attention in daily life
week 2,3,4,5,6,7,8 and 9 of intervention
Group cohesion during intervention
Periodo de tiempo: week 4 and week 9 during intervention
We will examine self-reported individual group cohesion ratings during the MBCT training with a Dutch Group Cohesion Questionnaire that has been used in cancer patients before (May et al., 2008). The GCQ-23 uses 22 items across four scales: the bond with the group as whole, the bond with other members, cooperation within the group and the instrumental value. Each item is rated from 1 (totally disagree) to 6 (totally agree). Internal consistency of all scales was reported to range from adequate to good (0.66-0.88).
week 4 and week 9 during intervention
Working alliance during intervention
Periodo de tiempo: week 4 and week 9 during intervention
The Working Alliance Inventory (WAI) is most often used to assess working alliance between participant and healthcare professional. We will use the Dutch translation of the short form (WAI-S, Vervaeke & Vertommen, 1996), which is closely related to the original scale and also has good psychometric and predictive quality (Busseri & Tyler, 2003). The WAI-S is a 12 item, self report questionnaire, rated on a 7-point Likert scale (1 = never to 7 = always) with three subscales: 1) agreement between participant and therapist on the goals of the therapy; 2) agreement on the rationale of the therapy addressing the problems of the participant; and 3) the quality of the interpersonal bond between the participant and the therapist.
week 4 and week 9 during intervention
Change in mood during intervention
Periodo de tiempo: week 2,3,4,5,6,7,8 and 9 of intervention
In the current study, positive and negative affect is assessed before each MBCT session using the International Positive and Negative Affect Scale - Short Form. The cross-sample stability, internal reliability, temporal stability, crosscultural factorial invariance, and convergent and criterion-related validities of the I-PANAS-SF were examined and found to be psychometrically acceptable (Thompson, 2007).
week 2,3,4,5,6,7,8 and 9 of intervention
Change from baseline in anxiety and depressive symptoms - follow up
Periodo de tiempo: 0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
Hospital Anxiety and Depression Scale - anxiety and depressive symptoms at follow up.
0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)

Colaboradores e Investigadores

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

Patrocinador

Radboud University Medical Center

Investigadores

  • Investigador principal: Anne EM Speckens, MD, PhD, Radboud University Medical Centre Nijmegen

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

Enlaces Útiles

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

1 de abril de 2014

Finalización primaria (Actual)

20 de julio de 2016

Finalización del estudio (Actual)

1 de mayo de 2017

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2014

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2014

Publicado por primera vez (Estimar)

14 de mayo de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de septiembre de 2017

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

18 de septiembre de 2017

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2012.WO14.C153
  • NL46338.091.13 (Identificador de registro: Toetsingonline)

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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