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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04841681
Other study ID # 20-05-0546
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2020
Est. completion date August 26, 2020

Study information

Verified date April 2021
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date August 26, 2020
Est. primary completion date August 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Indonesia dr. Cipto Mangunkusumo National General Hospital Jakarta Pusat DKI Jakarta

Sponsors (2)

Lead Sponsor Collaborator
Indonesia University National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (15)

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. doi: 10.1016/j.jhin.2010.04.027. Review. — View Citation

Behan C. The benefits of meditation and mindfulness practices during times of crisis such as COVID-19. Ir J Psychol Med. 2020 Dec;37(4):256-258. doi: 10.1017/ipm.2020.38. Epub 2020 May 14. — View Citation

Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26. Review. — View Citation

Cheng W, Zhang F, Hua Y, Yang Z, Liu J. Development of a psychological first-aid model in inpatients with COVID-19 in Wuhan, China. Gen Psychiatr. 2020 Jun 17;33(3):e100292. doi: 10.1136/gpsych-2020-100292. eCollection 2020. — View Citation

Conversano C, Di Giuseppe M, Miccoli M, Ciacchini R, Gemignani A, Orrù G. Mindfulness, Age and Gender as Protective Factors Against Psychological Distress During COVID-19 Pandemic. Front Psychol. 2020 Sep 11;11:1900. doi: 10.3389/fpsyg.2020.01900. eCollec — View Citation

Dekker RL, Moser DK, Peden AR, Lennie TA. Cognitive therapy improves three-month outcomes in hospitalized patients with heart failure. J Card Fail. 2012 Jan;18(1):10-20. doi: 10.1016/j.cardfail.2011.09.008. Epub 2011 Nov 9. — View Citation

Grazzi L, Rizzoli P, Andrasik F. Effectiveness of mindfulness by smartphone, for patients with chronic migraine and medication overuse during the Covid-19 emergency. Neurol Sci. 2020 Dec;41(Suppl 2):461-462. doi: 10.1007/s10072-020-04659-0. — View Citation

Liu K, Chen Y, Wu D, Lin R, Wang Z, Pan L. Effects of progressive muscle relaxation on anxiety and sleep quality in patients with COVID-19. Complement Ther Clin Pract. 2020 May;39:101132. doi: 10.1016/j.ctcp.2020.101132. Epub 2020 Mar 6. — View Citation

Nelson NA, Bergeman CS. Daily Stress Processes in a Pandemic: The Effects of Worry, Age, and Affect. Gerontologist. 2021 Feb 23;61(2):196-204. doi: 10.1093/geront/gnaa187. — View Citation

Nwachukwu I, Nkire N, Shalaby R, Hrabok M, Vuong W, Gusnowski A, Surood S, Urichuk L, Greenshaw AJ, Agyapong VIO. COVID-19 Pandemic: Age-Related Differences in Measures of Stress, Anxiety and Depression in Canada. Int J Environ Res Public Health. 2020 Sep 1;17(17). pii: E6366. doi: 10.3390/ijerph17176366. — View Citation

Reyes AT. A Mindfulness Mobile App for Traumatized COVID-19 Healthcare Workers and Recovered Patients: A Response to "The Use of Digital Applications and COVID-19". Community Ment Health J. 2020 Oct;56(7):1204-1205. doi: 10.1007/s10597-020-00690-9. Epub 2 — View Citation

Sherifali D, Ali MU, Ploeg J, Markle-Reid M, Valaitis R, Bartholomew A, Fitzpatrick-Lewis D, McAiney C. Impact of Internet-Based Interventions on Caregiver Mental Health: Systematic Review and Meta-Analysis. J Med Internet Res. 2018 Jul 3;20(7):e10668. doi: 10.2196/10668. — View Citation

Wei N, Huang BC, Lu SJ, Hu JB, Zhou XY, Hu CC, Chen JK, Huang JW, Li SG, Wang Z, Wang DD, Xu Y, Hu SH. Efficacy of internet-based integrated intervention on depression and anxiety symptoms in patients with COVID-19. J Zhejiang Univ Sci B. 2020 May;21(5):4 — View Citation

Zandifar A, Badrfam R, Yazdani S, Arzaghi SM, Rahimi F, Ghasemi S, Khamisabadi S, Mohammadian Khonsari N, Qorbani M. Prevalence and severity of depression, anxiety, stress and perceived stress in hospitalized patients with COVID-19. J Diabetes Metab Disord. 2020 Oct 29:1-8. doi: 10.1007/s40200-020-00667-1. [Epub ahead of print] — View Citation

Zarghami A, Farjam M, Fakhraei B, Hashemzadeh K, Yazdanpanah MH. A Report of the Telepsychiatric Evaluation of SARS-CoV-2 Patients. Telemed J E Health. 2020 Dec;26(12):1461-1465. doi: 10.1089/tmj.2020.0125. Epub 2020 Jun 11. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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)
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