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

Primary Purpose

Covid19, Distress, Emotional

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Video-based Psychotherapy
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring COVID-19, distress, patients in isolation wards, video-based psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • dr. Cipto Mangunkusumo National General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Video-based Psychotherapy

Arm Description

The group received the intervention of video-based psychotherapy.

Outcomes

Primary Outcome Measures

Change from Baseline Subjective Units of Distress (SUDS) at Right After Receiving Video-based Psychotherapy
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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2021
Last Updated
April 8, 2021
Sponsor
Indonesia University
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04841681
Brief Title
Video-based Psychotherapy for COVID-19 Patients in Isolation Ward in Jakarta
Official Title
Effectiveness of Video-based Psychotherapy in Reducing Distress in Patients With COVID-19 Treated in a Hospital Isolation Ward in Jakarta
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 7, 2020 (Actual)
Primary Completion Date
August 25, 2020 (Actual)
Study Completion Date
August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Distress, Emotional
Keywords
COVID-19, distress, patients in isolation wards, video-based psychotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study utilized the quasi-experimental design with a pre-test-post-test and without a control group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video-based Psychotherapy
Arm Type
Experimental
Arm Description
The group received the intervention of video-based psychotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Video-based Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Subjective Units of Distress (SUDS) at Right After Receiving Video-based Psychotherapy
Description
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
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
dr. Cipto Mangunkusumo National General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share the data of participants' (identities will be initials only) demographic data and SUDS score before and after watching the video.
IPD Sharing Time Frame
1 month after publication.
IPD Sharing Access Criteria
The data will be available through request to Petrin Redayani Lukman MD as the contact person, e-mail ptrn1010@yahoo.com.
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Video-based Psychotherapy for COVID-19 Patients in Isolation Ward in Jakarta

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