Covid19NCT04841681
Video-based Psychotherapy for COVID-19 Patients in Isolation Ward in Jakarta
A study testing Video-based Psychotherapy in people with Covid19 and Distress, Emotional, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Distress, Emotional
- What is being tested?
- Video-based Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Jun 2020to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Cipto Mangunkusumo National General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Video-based Psychotherapy in Reducing Distress in Patients With COVID-19 Treated in a Hospital Isolation Ward in Jakarta
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.
Read the 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.
- Conditions
- Covid19, Distress, Emotional
- Being tested
- Video-based Psychotherapy
- Keywords
- COVID-19, distress, patients in isolation wards, video-based psychotherapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based PsychotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-based Psychotherapy | Experimental | The group received the intervention of video-based psychotherapy. Receives: Behavioral: Video-based Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start7 Jun 2020
- Primary completion25 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study utilized the quasi-experimental design with a pre-test-post-test and without a control group.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Principal investigator, Petrin Redayani Lukman, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841681
- Sponsor's protocol ID
- 20-05-0546
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the data of participants' (identities will be initials only) demographic data and SUDS score before and after watching the video.
Publications
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.
PubMed 20619929Zandifar 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.
PubMed 33145259Brooks 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.
PubMed 32112714Zarghami 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.
PubMed 32525755Cheng 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.
PubMed 32596642Sherifali 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.
PubMed 29970358Nelson 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.
PubMed 33186445Nwachukwu 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.
PubMed 32882922Wei 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.
PubMed 32425006Liu 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.
PubMed 32379667Dekker 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.
PubMed 22196836Conversano 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.
PubMed 33013503Behan 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.
PubMed 32406348Grazzi 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.
PubMed 32794128Reyes 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.
PubMed 32772205
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video-based Psychotherapy in Reducing Distress in Patients With COVID-19 Treated in a Hospital Isolation Ward in Jakarta
- ClinicalTrials.gov ID
- NCT04841681
- Acronym / sponsor ID
- 20-05-0546
- Conditions
- Covid19, Distress, Emotional
- Keywords
- COVID-19, distress, patients in isolation wards, video-based psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilized the quasi-experimental design with a pre-test-post-test and without a control group.
| Arm | Type | Receives |
|---|---|---|
| Video-based Psychotherapy | Experimental | Behavioral: Video-based PsychotherapyThe group received the intervention of video-based psychotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-based PsychotherapyParticipants 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. | Behavioural | Video-based Psychotherapy |
Primary outcome
Change from Baseline Subjective Units of Distress (SUDS) at Right After Receiving 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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 20619929Abad 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.
- Background: PubMed 33145259Zandifar 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.
- Background: PubMed 32112714Brooks 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.
- Background: PubMed 32525755Zarghami 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.
- Background: PubMed 32596642Cheng 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.
- Background: PubMed 29970358Sherifali 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.
- Background: PubMed 33186445Nelson 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.
- Background: PubMed 32882922Nwachukwu 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.
- Results publication: PubMed 32425006Wei 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.
- Results publication: PubMed 32379667Liu 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.
- Results publication: PubMed 22196836Dekker 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.
- Results publication: PubMed 33013503Conversano 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.
- Individual participant dataSharing planned: Yes. We plan to share the data of participants' (identities will be initials only) demographic data and SUDS score before and after watching the video.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based Psychotherapy in people with Covid19 and Distress, Emotional, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Subjective Units of Distress (SUDS) at Right After Receiving 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841681, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.