- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04841681
Video-based Psychotherapy for COVID-19 Patients in Isolation Ward in Jakarta
Effectiveness of Video-based Psychotherapy in Reducing Distress in Patients With COVID-19 Treated in a Hospital Isolation Ward in Jakarta
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, 인도네시아, 10430
- Dr. Cipto Mangunkusumo National General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Video-based Psychotherapy
The group received the intervention of video-based psychotherapy.
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline Subjective Units of Distress (SUDS) at Right After Receiving Video-based Psychotherapy
기간: 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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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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20-05-0546
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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