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Video-based Psychotherapy for COVID-19 Patients in Isolation Ward in Jakarta

8 de abril de 2021 actualizado por: Petrin Redayani Lukman, Indonesia University

Effectiveness of Video-based Psychotherapy in Reducing Distress in Patients With COVID-19 Treated in a Hospital Isolation Ward in Jakarta

The COVID-19 pandemic has made severe impact worldwide for those inflicted by the disease, the caretakers, the general public, as well as the health care system. Hospitalized patients with COVID-19 experience physical isolation during treatment. Isolation may lead to psychological distress that could negatively affect well-being such as affective states of depression, anxiety, and loneliness. Thus, creative ways to deliver psycho-social support are needed when face-to-face therapy sessions may not possible. We investigated the effectiveness of video-based psychotherapy in reducing distress in patients with COVID-19 treated in a general hospital isolation ward in Jakarta. This study included 42 patients with COVID-19, who were asked to watch three brief psychotherapy videos about relaxation, managing thoughts and emotions, and mindfulness. Before and after watching the videos, patients were asked to complete the Subjective Units of Distress Scale (SUDS) to measure their stress level. 31 subjects experienced a significant decrease in SUDS score after the intervention. Our brief video-based psychotherapy intervention may have a positive effect on reducing distress in hospitalized COVID-19 patients in areas with scarce resources.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

The coronavirus disease 2019 (COVID-19) pandemic has brought severe consequences worldwide. Indonesia is one of the countries which has been affected by this pandemic. The examination, treatment, and monitoring of individuals with COVID-19 often requires them to be in a hospital isolation ward. There are a lot of factors which could negatively affect the mental health of such patients during their isolation, to the point that they develop significantly debilitating conditions.

Several psychotherapy interventions have been known to be effective during a pandemic situation. The interventions include those based on techniques of relaxation, managing thoughts and feelings, and mindfulness. These methods could help reducing negative and catastrophic thoughts about the future, reducing distress level and hyperarousal, and other beneficial effect. However, due to the high transmission rate of SARS-CoV-2 virus (severe acute respiratory syndrome-coronavirus 2), face-to-face therapy sessions are rendered difficult to hold under the circumstances. Thus, we conducted a pilot study to test the impact of a video-based psychotherapy intervention on distress and well-being in hospitalized COVID-19 patients in a medical isolation ward.

This pilot study included 42 patients with COVID-19, aged 20-59. Participants watched three brief psychotherapy videos covering relaxation, managing thoughts and emotions, and mindfulness. Before and after watching the videos, patients were asked to complete the Subjective Units of Distress Scale (SUDS). 31 subjects experienced a significant median decrease in SUDS score after the intervention. The effect size was 0.485, with a 95% confidence interval of 0.302 to 0.634. Our brief video-based psychotherapy intervention may have a positive effect on reducing distress in hospitalized COVID-19 patients in areas with scarce resources. This study could be used as a reference for future studies regarding the method of choice for delivering psychotherapy intervention for patients in isolation ward during the COVID-19 pandemic.

Tipo de estudio

Intervencionista

Inscripción (Actual)

42

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

    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Dr. Cipto Mangunkusumo National General Hospital

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:

  • Patients with COVID-19 in Kiara Ultimate CMH (Cipto Mangunkusumo Hospital) isolation ward who are at least 18 years old
  • Patients with COVID-19 in Kiara Ultimate CMH isolation ward who are able to give an informed consent
  • Patients with COVID-19 in Kiara Ultimate CMH isolation ward who agreed to watch the psychotherapy videos about relaxation, managing thoughts and feelings, and mindfulness using electronic devices provided by the research team or their own devices independently

Exclusion Criteria:

  • Patients in unstable conditions such as patients on a ventilator, experiencing breathing difficulties, or in need of oxygen support, with fluctuating levels of consciousness
  • Patients with physical and intellectual disabilities that may hinder ability to understand instructions of the video-based psychotherapy intervention

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: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Video-based Psychotherapy
The group received the intervention of video-based psychotherapy.

Participants in the group watched three short videos. Therapeutic elements in the three consecutive short videos included relaxation therapy, managing thoughts and feelings, and mindfulness. Each video has a duration of just over 10 minutes.

In the first video, the participants were introduced to the purpose and benefits of relaxation techniques. These included rhythmic breathing techniques, progressive muscle relaxation, imagining a comforting and quiet place, and positive self-talk. In the second video about managing thoughts and feelings, the participants were introduced to the notion of acceptance of their condition. They were invited to recognize the emergence of negative feelings and thoughts related to acceptance. In the last video about mindfulness, patients were introduced to three basic mindfulness skills: observation, elaboration, and participation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline Subjective Units of Distress (SUDS) at Right After Receiving Video-based Psychotherapy
Periodo de tiempo: Baseline (before receiving the intervention of video-based psychotherapy) and immediately after receiving the intervention of video-based psychotherapy (right after the participants have finished watching the 30 minutes-long psychotherapy videos)

Subjective Units of Distress (SUDS) is a self-rating instrument used to measure the distress level of an individual in a numeric scale from the scale of 0 (no distress) to 10 (extreme distress).

Change = score right after participants have received the video-based psychotherapy - baseline score before they received the video-based psychotherapy

Baseline (before receiving the intervention of video-based psychotherapy) and immediately after receiving the intervention of video-based psychotherapy (right after the participants have finished watching the 30 minutes-long psychotherapy videos)

Colaboradores e Investigadores

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

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)

7 de junio de 2020

Finalización primaria (Actual)

25 de agosto de 2020

Finalización del estudio (Actual)

26 de agosto de 2020

Fechas de registro del estudio

Enviado por primera vez

6 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

8 de abril de 2021

Publicado por primera vez (Actual)

12 de abril de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de abril de 2021

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

8 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

We plan to share the data of participants' (identities will be initials only) demographic data and SUDS score before and after watching the video.

Marco de tiempo para compartir IPD

1 month after publication.

Criterios de acceso compartido de IPD

The data will be available through request to Petrin Redayani Lukman MD as the contact person, e-mail ptrn1010@yahoo.com.

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 COVID-19

Ensayos clínicos sobre Video-based Psychotherapy

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