Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Mindfulness-based Intervention for Postnatal Depression

30 de marzo de 2020 actualizado por: Dr. Jingxia Lin, The University of Hong Kong

The Impacts of Mindfulness-based Intervention on Symptoms and Cognition in Chinese Women With Postnatal Depressive Symptoms - A Randomized Controlled Clinical Trial

Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms.

A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks.

The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

70

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.

Estudio Contacto

  • Nombre: Jingxia Lin, PhD
  • Número de teléfono: 852-39176311
  • Correo electrónico: jxlin@hku.hk

Ubicaciones de estudio

  • Hong Kong
      • Hong Kong, Hong Kong
        • Reclutamiento
        • Queen Mary Hospital
        • Contacto:
          • Jingxia Lin, PhD
          • Número de teléfono: 852-39176311
          • Correo electrónico: jxlin@hku.hk

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

Femenino

Descripción

Inclusion Criteria:

  • Females aged from 18 and above
  • The Edinburgh Postnatal Depression Scale cut-off score of >=9
  • At least 6 weeks, and up to one and half years after childbirth
  • Cantonese-speaking Chinese

Exclusion Criteria:

  • Severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which yoga may be contraindicated), and seizure disorders.
  • Comorbid substance dependence
  • Women with psychotic depression, severe eating disorders, actively suicidal or obsessive-compulsive disorders
  • Known pregnancy
  • A history of bipolar disorder, schizophrenia, brain trauma or organic brain disease, mental retardation, or antisocial personality disorder
  • Practice of mindfulness (in forms of Tai Chi, Qi gong or yoga etc.) more than twice a week during the previous three months.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Mindfulness-based intervention
Conductual: Mindfulness-based program (MBI-p-R)
The MBI-p-R was developed in line with the model of Mindfulness-based Stress Reducation (MBSR) proposed by Kabat-Zinn. It will be conducted for 1.5 hours for each session, once a week for 8 weeks. There are four key operational components to be included in each session: engagement and introduction, mindfulness practices, daily life application, and consolidation of learning.
Comparador activo: Booklet-based psychoeducation group
Conductual: Booklet-based psychoeducation
The participants in the control group will be provided a booklet at baseline, including general information in handling every day stress by a new mother, as well as a record for their weekly activities. The contents covered a range of topics including work-stress, balanced diet, physical exercise, sleeping quality, bonding with baby and the treatment for depression. The participants will be contacted by phone call and/or whatsapp weekly for a short talk based on the record and content on the booklet. They will also be asked to record their daily life weekly for discussion.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline Depression at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Depression at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
The Edinburgh Postnatal Depression Scale, total score 0-30, higher scores mean worse outcome.
Change from 8 weeks to 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline Anxiety at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Anxiety at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Depression Anxiety Stress Scale, Anxiety subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks to 3 months
Change from Baseline Stress at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Stress at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Depression Anxiety Stress Scale, Stress subscore 0-42, higher scores mean worse outcome.
Change from 8 weeks to 3 months
Change from Baseline Executive Function at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Executive Function at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Trial Making Test, reaction time is recorded, shorter time means better outcome.
Change from 8 weeks to 3 months
Change from Baseline Attention at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Attention at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Letter Cancellation Test, correct rate and time are recorded, higher correct rate and shorter time mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Working Memory at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Working Memory at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Digit-Span Test, minimum 0, maximum 14, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Visual-Motor Coordination at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Visual-Motor Coordination at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Digit-Symbol-Coding Test, minimum 0, maximum 133, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Role Functioning at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Role Functioning at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Role Functioning Scale, minimum 4, maximum 38, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Quality of Life at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Quality of Life at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
The Short Form Health Survey, minimum score 0, and maximum score 100, higher scores mean better outcome.
Change from 8 weeks to 3 months
Change from Baseline Sleep Quality at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from baseline to 8 weeks
Change from 8 weeks Sleep Quality at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
Pittsburg Sleep Quality Index, minimum 0, maximum 21, higher scores mean worse outcome.
Change from 8 weeks to 3 months
Change from Baseline Mindfulness Levels at 8 weeks
Periodo de tiempo: Change from baseline to 8 weeks
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Change from baseline to 8 weeks
Change from 8 weeks Mindfulness Levels at 3 months
Periodo de tiempo: Change from 8 weeks to 3 months
The Five Facet Mindfulness Questionnaire-Revised, minimum 39, maximum 195, higher scores mean better outcome.
Change from 8 weeks to 3 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Total attendant classes during the 8-week interventions
Periodo de tiempo: At 8 weeks
The number of classes the participants attended during the 8-week period will be recorded
At 8 weeks
Self-practice time
Periodo de tiempo: At 8 weeks
How much time the participants spend for self-practice at home will be recorded
At 8 weeks
Self-practice time
Periodo de tiempo: At 3 months
How much time the participants spend for self-practice at home will be recorded
At 3 months

Colaboradores e Investigadores

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

Patrocinador

The University of Hong Kong

Investigadores

  • Investigador principal: Jingxia Lin, PhD, The University of Hong Kong

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 septiembre de 2019

Finalización primaria (Anticipado)

1 de julio de 2020

Finalización del estudio (Anticipado)

1 de septiembre de 2021

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2020

Primero enviado que cumplió con los criterios de control de calidad

30 de marzo de 2020

Publicado por primera vez (Actual)

2 de abril de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de abril de 2020

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

30 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • UW17-431

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The study protocol, statistical analysis plan and clinical study report will be shared through email.

Marco de tiempo para compartir IPD

Within one year after the completion of the study.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

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 Depresion postnatal

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Georgia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir