Effectiveness of Video-based Psychotherapy in Reducing Distress in Patients With COVID-19 Treated in a Hospital Isolation Ward in Jakarta
Phase: NA
Conditions: Covid19, Distress, Emotional
Sponsor: Indonesia University

 
 
 
2021 
Effectiveness of video-based psychotherapy in reducing 
distress in patients with COVID-19 treated in a hospital 
isolation ward in Jakarta 
STUDY PROTOCOL & STATISTICAL ANALYSIS PLAN 
20 MARCH 2021 

STUDY PROTOCOL 
Effectiveness of video-based psychotherapy in reducing distress in patients 
with COVID-19 treated in a hospital isolation ward in Jakarta 
 
1. Introduction 
1.1 Background 
The coronavirus disease 2019 (COVID-19) pandemic has brought severe consequences 
worldwide. Until now, there has been 693,282 cases and 33.106 mortality assosciated with this 
disease, with Italy having the highest number of cases and death globally. World Health 
Organization (WHO)’s disease risk assessment has shown that this disease has a very high risk 
on a worldwide scale [1]. 
Indonesia is one of the countries which has been affected by this pandemic. There has been 
1,285 cases and 114 death recorded so far [1]. Through the Department of Health, the 
Indonesian government has responded to the pandemic by conducting several measures to 
prevent and to mitigate the disease. The measures include surveillance, early detection, contact 
tracing, quarantine, plague mitigation, clinical management, prevention and infection control, 
management of laboratory specimens, risk communication, as well as community 
empowerment [2]. 
The examination, treatment, and monitoring of individuals with COVID-19 often requires them 
to be in a hospital isolation ward [2]. 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. Studies on the effect of treatment in isolation wards on 
hospitalized patients demonstrate detrimental effects on the patients’ psychological condition 
and associated behavioural disturbance as a result of isolation, including affective states of 
depression, anxiety, anger, hostility, fear and loneliness [3]. 
Several psychoterapy 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 [4]. However, due to the high transmission rate of SARS-CoV-2 virus, face-
to-face therapy sessions are rendered difficult to hold under the circumstances. 
Kiara Ultimate is the place where COVID-19 patients are treated and monitored in CMH (Cipto 
Mangunkusumo Hospital). A psychotherapy intervention is a potentially promising 
intervention that could be provided to reduce the distress of the many patients being treated or 
monitored in this ward. In practice, providing psychotherapy via video is an alternative method 
when face-to-face therapy sessions are not possible in order to practice adequate infection 
control, especially with patients treated in an isolation ward. This study will be conducted with 
hopes that it could show how video-based psychotherapy could reduce the distress of COVID-
19 patients treated in an isolation ward. 
 

1.2 Research Problem 
Being treated  in an isolation ward for treatment or monitoring purposes could bring detrimental 
effects to the psychological condition of COVID-19 patients. The psychotherapy techniques 
based on relaxation, managing thoughts and feelings, and mindfulness are methods of 
intervention that could be applied to reduce distress on those patients. Therefore, an 
investigation on the role of video-based psychotherapy in reducing the distress of COVID-19 
patients treated in an isolation ward would be needed before the interventions could be 
practiced in real-life clinical settings. 
1.3 Hypothesis 
H0: There is no significant change in SUDS score of COVID-19 patients in isolation ward 
before and after watching the video-based psychotherapy. 
H1: There is a significant change in SUDS score of COVID-19 patients in isolation ward before 
and after watching the video-based psychotherapy. 
1.4 Objectives of Research 
1.4.1 General Objective 
 To determine the effectivity of video-based psychotherapy on reducing the distress of 
COVID-19 patients in Kiara Ultimate CMH isolation ward. 
1.4.2 Specific Objectives 
 To acquire the mean or median of the score of psychological distress of COVID-19 
patients in Kiara Ultimate CMH isolation ward before receiving video-based 
psychotherapy. 
 To acquire the mean or median of the score of psychological distress of COVID-19 
patients in Kiara Ultimate CMH isolation ward after receiving video-based 
psychotherapy. 
 To acquire the mean or median of the changes in the score of psychological distress of 
COVID-19 patients in Kiara Ultimate CMH isolation ward after receiving video-based 
psychotherapy, compared to before receiving the intervention. 
1.5 Significance of Research 
Determining the role of video-based psychotherapy in reducing the distress of COVID-19 
patients in Kiara Ultimate CMH isolation ward could bring about these benefits: 
 In the field of clinical setting and community services: 
o COVID-19 patients who are treated in the hospital isolation ward could receive 
psychotherapy services in the form of techniques based on relaxation, managing 
thoughts and feelings, and mindfulness, which could help reduce their 
psychological distress as they go through their treatment. 
o Acquiring a general idea on what kind of psychotherapy tecnique would be the 
most effective to be provided to COVID-19 patients treated in an isolation ward. 
 In the field of science: 

o A study on psychotherapy for COVID-19 patients treated in an isolation ward 
could contribute further knowledge for the field of psychiatry, especially on the 
field of psychotherapy. 
 In the field of research: 
o The outcome of this research could be used as a reference for further studies on 
the methods of psychotherapy that could be delivered to patients being treated 
in an isolation ward in the future. 
3.  Methodology 
3.1 Study Design 
This study utilized the quasi-experimental design with a pre-test-post-test and without a control 
group. 
3.2 Time and Location of the Study 
This study will be conducted in Kiara Ultimate CMH isolation ward, from June 2020 until 
August 2020. 
3.3 Population and Sample  
The target population of this study is all COVID-19 patients in hospital isolation wards. The 
The accessible population of this study is all COVID-19 patients in the Kiara Ultimate CMH 
isolation ward. Samples would be COVID-19 patients in the Kiara Ultimate CMH isolation 
ward who fit the inclusion criteria. Due to the limited number of patients in the isolation ward 
that would make performing a true randomization difficult, participants would be selected 
through convenience sampling. 
3.4 Sample Size 
The sample size required in this study is determined through the formula for testing the 
hypothesis on the mean of two paired populations as following: 
 
 
 
Description: 
n = minimal sample size required 
 = type I error 
  = type II error 
 Sd= standard deviation of mean difference 
 
d =  mean difference of SUDS score that is determined as clinically significant 
 
 is determined as 0,05, power as 0,9 (Power = 1- ), standard deviation of mean difference as 
4, and mean difference of SUDS score of 2 is determined as clinically significant. By these 
values, the minimum sample size required was determined as: 
n = [ 
(Z + Z) x Sd ] 
2 
d 
 

 
 
 
 
3.5 
Inclusion and Exclusion Criteria 
3.5.1 Inclusion Criteria 
The inclusion criteria for participating in this study are: 
 Patients with COVID-19 in Kiara Ultimate CMH 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 
3.5.2 Exclusion Criteria 
The exclusion criteria for participating in this study are: 
 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 
3.6 
Research Approval 
The approval that would be required to carry out this study would be: 
 Approval from Department of Psychiatry Faculty of Medicine Universitas Indonesia-
Cipto Mangunkusumo Hospital 
 Approval from Faculty of Medicine Universitas Indonesia Research Ethics Committee 
3.7 
Research Procedure 
A. Preparation  
Preparation starts from applying for permission to carry out the study to the appropriate parties, 
namely the Faculty of Medicine Universitas Indonesia Research Ethics Committee, the head 
of Department of Psychiatry Faculty of Medicine Universitas Indonesia-Cipto Mangunkusumo 
Hospital, and the head of Emergency Room of Cipto Mangunkusumo Hospital. 
B. Participants Recruitment and Follow-Up 
 The research team provides a banner or poster with the information on the research 
about video-based psychotherapy to be placed in Kiara Ultimate CMH isolation ward, 
as well as a web link to the online research forms and the psychotherapy videos. 
n = [ 
(1,96 + 1,28) x 4 ] 
2 
2 
 
n = 
 
42 subject 
 
 
 

 Every day during the recruitment period, the health care workers in Kiara Ultimate 
CMH isolation ward would check if there were any patients in the isolation criteria who 
meet the inclusion criteria for the study 
 If such patients are currently in the isolation ward, the health care workers would collect 
their contact information and inform it to the research team 
 Patients who meet the criteria would be contacted by the research team. During contact, 
the research team would ask for their informed consent to participate in the study via 
voice call or video call 
 The health care workers would provide patients who agree to participate with links for 
video access, online research forms, and a written informed consent form for them to 
sign. Patients who don’t wish to participate would still be offered to watch the videos. 
Participants could choose to watch the videos using an electronic device provided by 
the research team, or using their own devices 
 Participants would be given bathing equipments such as a towel and soaps as incentives 
for going through the research protocol 
 The data which would be collected through the research form includes demographic 
data, length of stay in the isolation ward, as well as the distress score before and after 
watching the videos measured using the Subjective Units of Distress Scale (SUDS) 
3.8 Data Processing and Stastitical Analysis Plan 
Data will be stored in a specific online data registry. Confidentiality of the data will be 
guaranteed by the research team. Statistical analyses will be performed using SPSS software 
version 20.  The changes in SUDS score will be analysed through the analysis for comparison 
of two population means of paired samples. 
The main analysis in this study is the investigation of the changes in SUDS score before and 
after watching the video-based psychotherapy. Analysis was also done on the participants’ 
demographic data to generate information on the characteristic distribution of the participants. 
The participant’s demographic characteristics data that were analysed included age, sex, level 
of education, occupation, and marital status. Tests of normality for the numeric data was done 
through the Shapiro-Wilk normality test, with the p-value of >0,05  as the indicator for rejecting 
the null hypothesis. Normality tests were performed on the numeric variables in the study 
namely age, SUDS score before and after watching the video-based, and participants’ length 
of stay in the isolation ward. 
Investigation of the change in SUDS score was done through a bivariate analysis, to see 
whether there was a significant difference between the mean SUDS scores before and after 
watching the three video-based psychotherapy interventions in the two paired groups. As the 
numeric variables turned out to have non-normal disributions, the non-parametric statistical 
hypothesis test Wilcoxon-signed rank test was performed on the data. A significant association 
was decided as p-values <0,05. Statistical analyses were performed using SPSS software 
version 20. 
3.9 Instrument 
The instrument that will be used for data collection in this study is Subjective Units of Distress 
Scale (SUDS). The SUDS is used to measure the distress level of an individual in a numeric 
scale. The SUDS is a self-rating instrument. 

3.10 Definition of Terms 
 Psychotherapy: A form of therapy which utilizes psychological methods, conducted by 
a professional or a trained expert who forms a professional relationship with a patient 
with the aim of reducing, modificating, or eliminating the symptoms and suffering 
caused by their mental disorders or illness. 
 Video-based  psychotherapy: The use of video as a medium to deliver psychotherapy 
to patients.  
 Relaxation: A number of techniques which involves alternatingly tensing and relaxing 
specific muscle groups to reach a state of deep muscle relaxation, with the goal of 
reducing anxiety and mental tension. 
 Managing thoughts and feelings: A cognitive therapy technique which is designed to 
help patients feel more comfortable about themselves and acquire the capability to 
adapt to their circumstances through changing their perspective about themselves, their 
environment, and their circumstances. 
 Mindfulness: A process of focusing one’s attention solely to the experiences that are 
occuring in the present without associating it with other thoughts or feelings in a 
judging way, with the aim of of helping increase their capability to accept their current 
circumstances. 
 COVID-19 patients: Patients who have been diagnosed with COVID-19, with or 
without other conditions. 
 Subjective Units of Distress (SUDS): a self-rating instrument for measuring distress in 
individuals. Individuals give a score that is supposed to represent their subjective 
experience of distress on a scale of 0 - 10 (numeric), with a score of 0 representing “no 
distress” and a score of 10 representing “very severe or extreme distress”. 
3.11 Ethical Approval of the Research 
Application for the permission to carry out this research has been submitted to the Faculty of 
Medicine Universitas Indonesia Research Ethics Committee. Data of all subjects in this study 
will be kept confidential. The informed consent form that will be given to the participants will 
contain a detailed explanation about the protocol of the research. Patients will be informed that 
they are free to refuse participating in the study and there would not be any negative 
consequences inflicted on them. 
All participants were informed of the study protocol through the informed consent form that 
they had to sign. All subject data in this study were kept confidential by the research team. All 
procedures involving human subjects were approved by the Faculty of Medicine Universitas 
Indonesia Research Ethics Committee. Application for permission to carry out this research 
was submitted to the Faculty of Medicine Universitas Indonesia Research Ethics Committee. 
 
3.12 Research Team 
Head Researcher 
: 
Petrin Redayani Lukman, MD 
Researcher Members : 
Sylvia Detri Elvira, MD  
Heriani, MD 

Alfi Fajar Almasyhur, MD 
Alvin Saputra, MD 
Leonita Ariesti Putri, MD 
César A. Alfonso, MD 
Reina Rahma Noviasari, MD 
 
4. References 
1. 
World Health Organization. Coronavirus disease 2019 (COVID-19) Situation 
Report–70. 2020 [cited 2020 Apr]. In: Coronavirus disease 2019  (COVID-19) 
Situation Report  [Internet]. Geneva: World Health Organization. Available from: 
https://www.who.int/docs/default-source/coronaviruse/situation-
reports/20200330-sitrep-70-covid-19.pdf?sfvrsn=7e0fe3f8_4 
2. 
Aziza L, Aqmarina A, Ihsan M. Pedoman pencegahan dan pengendalian 
coronavirus disease (COVID-19). 1st ed. Jakarta: Kementerian Kesehatan RI 
Direktorat Jenderal Pencegahan dan Pengendalian Penyakit (P2P); 2020.  
3. 
Abad C, Fearday A, Safdar N. Adverse effects of isolation in hospitalised patients: 
A systematic review. J Hosp Infect. 2010 Oct; 76(2): 97–102.  
4. 
Huremović D. Psychiatry of pandemics: A mental health response to infection 
outbreak. 1st ed. Manhasset: Springer; 2019.