NCT04841681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 6, 2021

Last Update Submit

April 8, 2021

Conditions

Keywords

COVID-19distresspatients in isolation wardsvideo-based psychotherapy

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Video-based Psychotherapy

EXPERIMENTAL

The group received the intervention of video-based psychotherapy.

Behavioral: Video-based Psychotherapy

Interventions

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.

Video-based Psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

dr. Cipto Mangunkusumo National General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related 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.

    PMID: 20619929BACKGROUND
  • 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;19(2):1431-1438. doi: 10.1007/s40200-020-00667-1. eCollection 2020 Dec.

    PMID: 33145259BACKGROUND
  • 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.

    PMID: 32112714BACKGROUND
  • 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.

    PMID: 32525755BACKGROUND
  • 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.

    PMID: 32596642BACKGROUND
  • 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.

    PMID: 29970358BACKGROUND
  • 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.

    PMID: 33186445BACKGROUND
  • 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):6366. doi: 10.3390/ijerph17176366.

    PMID: 32882922BACKGROUND
  • 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):400-404. doi: 10.1631/jzus.B2010013. Epub 2020 Apr 1.

  • 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.

  • 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.

  • Conversano C, Di Giuseppe M, Miccoli M, Ciacchini R, Gemignani A, Orru 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. eCollection 2020.

  • 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.

  • 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.

  • 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 2020 Aug 9. No abstract available.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study utilized the quasi-experimental design with a pre-test-post-test and without a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 12, 2021

Study Start

June 7, 2020

Primary Completion

August 25, 2020

Study Completion

August 26, 2020

Last Updated

April 12, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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

Time Frame
1 month after publication.
Access Criteria
The data will be available through request to Petrin Redayani Lukman MD as the contact person, e-mail ptrn1010@yahoo.com.

Locations