scholarly journals A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Alejandro Dominguez-Rodriguez ◽  
Anabel De La Rosa-Gómez ◽  
M Jesús Hernández Jiménez ◽  
Paulina Arenas-Landgrave ◽  
Sofía Cristina Martínez-Luna ◽  
...  
Keyword(s):  
Mental Health ◽  
Positive Psychology ◽  
Behavioral Activation ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Web Based ◽  
Significance Level ◽  
Randomized Controlled

BACKGROUND The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping. OBJECTIVE This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system. METHODS A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group). RESULTS The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen <i>d</i> index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic. CONCLUSIONS The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic. CLINICALTRIAL ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23117

scholarly journals A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial

10.2196/23117 ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. e23117
Author(s):  
Alejandro Dominguez-Rodriguez ◽  
Anabel De La Rosa-Gómez ◽  
M Jesús Hernández Jiménez ◽  
Paulina Arenas-Landgrave ◽  
Sofía Cristina Martínez-Luna ◽  
...  
Keyword(s):  
Mental Health ◽  
Positive Psychology ◽  
Behavioral Activation ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Web Based ◽  
Significance Level ◽  
Randomized Controlled

Background The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping. Objective This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system. Methods A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group). Results The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen d index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic. Conclusions The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic. Trial Registration ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893 International Registered Report Identifier (IRRID) DERR1-10.2196/23117

Transdiagnostic versus Diagnosis-Specific Group Cognitive Behavioral Therapy for Anxiety Disorders and Depression: A Randomized Controlled Trial

2021 ◽  
pp. 1-14
Author(s):  
Nina Reinholt ◽  
Morten Hvenegaard ◽  
Anne Bryde Christensen ◽  
Anita Eskildsen ◽  
Carsten Hjorthøj ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Health Services ◽  
Health Services ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Major Depressive ◽  
Outpatient Mental Health ◽  
End Of Treatment

<b><i>Introduction:</i></b> The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) delivered in a group format could facilitate the implementation of evidence-based psychological treatments. <b><i>Objective:</i></b> This study compared the efficacy of group UP and diagnosis-specific cognitive behavioral therapy (dCBT) for anxiety and depression in outpatient mental health services. <b><i>Methods:</i></b> In this pragmatic, multi-center, single-blinded, non-inferiority, randomized controlled trial (RCT), we assigned 291 patients with major depressive disorder, social anxiety disorder, panic disorder, or agoraphobia to 14 weekly sessions in mixed-diagnosis UP or single-diagnosis dCBT groups. The primary test was non-inferiority, using a priori criteria, on the World Health Organisation 5 Well-Being Index (WHO-5) at the end of the treatment. Secondary outcomes were functioning and symptoms. We assessed outcomes at baseline, end-of-treatment, and at a 6-month follow-up. A modified per-protocol analysis was performed. <b><i>Results:</i></b> At end-of-treatment, WHO-5 mean scores for patients in UP (<i>n</i> = 148) were non-inferior to those of patients in dCBT (<i>n</i> = 143; mean difference –2.94; 95% CI –8.10 to 2.21). Results were inconclusive for the WHO-5 at the 6-month follow-up. Results for secondary outcomes were non-inferior at end-of-treatment and the 6-month follow-up. Client satisfaction and rates of attrition, response, remission, and deterioration were similar across conditions. <b><i>Conclusions:</i></b> This RCT demonstrated non-inferior acute-phase outcomes of group-delivered UP compared with dCBT for major depressive disorder, social anxiety disorder, panic disorder, and agoraphobia in outpatient mental health services. The long-term effects of UP on well-being need further investigation. If study findings are replicated, UP should be considered a viable alternative to dCBT for common anxiety disorders and depression in outpatient mental health services.

scholarly journals Efficacy and moderation of mobile application-based mindfulness-based training, self-compassion training, and cognitive-behavioral psychoeducation on mental health: A randomized controlled trial (Preprint)

2017 ◽  
Author(s):  
Winnie Wing Sze Mak ◽  
Alan Chun Yat Tong ◽  
Sindy Ying Chi Yip ◽  
Wacy Wai Sze Lui ◽  
Floria Hin Ngan Chio ◽  
...  
Keyword(s):  
Mental Health ◽  
Psychological Distress ◽  
Mobile Applications ◽  
Mobile Application ◽  
Controlled Trial ◽  
Well Being ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Self Compassion

BACKGROUND Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, the present study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile applications in the improvement of mental health. OBJECTIVE Our aim was to examine the efficacy of three mobile application-based programs: mindfulness-based program (MBP), self-compassion program (SCP), and cognitive behavioral psychoeducation control (CBP) in improving well-being and reducing psychological distress. To further delineate the suitability of each program for which type of individuals, individual difference variables (i.e., nonattachment, self-criticism, discomfort with emotion, and tolerance for ambiguity) were explored for potential moderation. METHODS The present study was a three-arm randomized controlled trial examining the efficacy of MBP, SCP with CBP. The course contents of the three programs were composed by a clinical psychologist and the mobile application was fully automated. Participants were recruited online and offline via mass mail, advertisements in newspapers and magazines, and social networking site. They were randomized into either one of the three conditions and completed pre-program survey assessment. Throughout the 4-week, 28-session program, participants spent 10 minutes daily in reviewing the course content and practicing various related exercises. Post-assessment and 3-month follow-up surveys were administered to measure changes over time. Indicators of mental health and psychological distress, as well as proposed moderators were self-assessed online at pre-program, post-program, and 3-month follow-up. RESULTS Among the 2,161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment respectively. All three conditions (MBP, N = 703; CBP, N = 753; SCP, N = 705) were found to be efficacious in improving mental well-being and reducing psychological distress. No significant differences regarding usage and users’ satisfaction were found among the three conditions. None of the proposed moderators were found to be significant. CONCLUSIONS Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile applications were efficacious in improving mental health and reducing psychological distress among young adults at post-program, and such improvements were maintained at 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rate that are common in app-based health promotion programs. CLINICALTRIAL Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; https://www2.ccrb.cuhk.edu.hk/registry/public/217 (Archived by WebCite at http://www.webcitation.org/6oaPwga7z).

scholarly journals Feasibility and Effectiveness of a Web-Based Positive Psychology Program for Youth Mental Health: Randomized Controlled Trial

2014 ◽  
Vol 16 (6) ◽  
pp. e140 ◽  
Author(s):  
Vijaya Manicavasagar ◽  
Deserae Horswood ◽  
Rowan Burckhardt ◽  
Alistair Lum ◽  
Dusan Hadzi-Pavlovic ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Positive Psychology ◽  
Controlled Trial ◽  
Youth Mental Health ◽  
Web Based ◽  
Randomized Controlled ◽  
Psychology Program

scholarly journals Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial

10.2196/20167 ◽  
2020 ◽  
Vol 4 (11) ◽  
pp. e20167
Author(s):  
Angel Enrique Roig ◽  
Olwyn Mooney ◽  
Alicia Salamanca-Sanabria ◽  
Chi Tak Lee ◽  
Simon Farrell ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Waiting List ◽  
Web Based ◽  
Randomized Controlled ◽  
Automated Support ◽  
Pilot Randomized Controlled Trial

Background College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. Objective This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. Methods A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. Results All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. Conclusions Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034 International Registered Report Identifier (IRRID) RR2-10.1016/j.invent.2019.100254

scholarly journals Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Luisa Weiner ◽  
Fabrice Berna ◽  
Nathalie Nourry ◽  
François Severac ◽  
Pierre Vidailhet ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Perceived Stress ◽  
Healthcare Workers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Healthcare Systems ◽  
Randomized Controlled

Abstract Background The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders, and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the ‘My Health too’ CBT program—a program we have developed for healthcare workers facing the pandemic—on immediate perceived stress and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy). Methods Powered for superiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels > 16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores at 8 weeks. Secondary outcomes include depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks), and at 3-month and 6-month follow-up. Discussion This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers’ mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis. Trial registration ClinicalTrials.gov NCT04362358, registered on April 24, 2020.

scholarly journals A Web-Based Intervention for Young Adults Whose Parents Have a Mental Illness or Substance Use Concern: Protocol for a Randomized Controlled Trial

10.2196/15626 ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. e15626
Author(s):  
Darryl Maybery ◽  
Andrea Reupert ◽  
Catherine Bartholomew ◽  
Rose Cuff ◽  
Zoe Duncan ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Substance Use ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
Within Subjects ◽  
Time Periods

Background One in 5 young people grow up in a family where one parent has experienced a mental health problem or substance use concern. Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue. There is a paucity of accessible, age-appropriate interventions that address their needs. Objective A 6-week, web-based intervention, “mental illness: supported, preventative, online, targeted” (mi.spot), was developed based on previous research and the competence enhancement model. This paper describes the protocol for a randomized controlled trial and details how the usage, safety, acceptability, and feasibility of the intervention will be determined. Methods Participants will be recruited through social media and clinician referral. A total of 70 Australians, aged 18 to 25 years, who grew up with parents with a mental illness or substance use concern will participate in a 2-arm parallel randomized controlled trial. The assessment will consist of a baseline measurement and 2 follow-up periods, posttest and 6-week follow-up, using the Mental Health Continuum short form; the Depression, Anxiety, and Stress Scale; the Coping Orientation to Problems Experienced inventory; the General Help Seeking Questionnaire; the Social Connectedness Scale; the Mental Health Literacy Scale; the General Self-Efficacy Scale; and the Attribution of Responsibility for Parental Mental Illness Measure. Impact will be examined at pre, post, and follow-up time periods using analyses of variance that will include a within-subjects factor (time) and a between-subjects factor (intervention/control). Facilitator interviews will ascertain intervention feasibility. Participant interviews will ascertain intervention acceptability. Interview data will be analyzed within a qualitative framework. Usage (data analytics) across site features and several indicators of clinical safety will also be reported. Results The impact of mi.spot will be examined at pre, post, and follow-up time periods using analyses of variance on each of the measures outlined above. There will be a within-subjects factor (time) and a between-subjects factor (intervention/control). Data analysis will employ the intention-to-treat principle by including all participants in the analyses. Qualitative interview data will be analyzed using interpretative phenomenological analysis along with respondent validation. The Monash University Human Research Ethics Committee (reference number: 2019-18660-30434) approved the trial on April 17, 2019. As of October 2, 2019, 30 participants were enrolled in the control group and 34 participants were enrolled in the intervention group. Result are expected to be submitted for publication in December 2020. Conclusions Study results will provide reliable evidence on a web-based intervention that has the potential to make a difference to the lives of many vulnerable young adults. Implementation guidelines are needed to embed the intervention in different service sectors. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12619000335190; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000335190 International Registered Report Identifier (IRRID) DERR1-10.2196/15626

scholarly journals Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Angel Enrique Roig ◽  
Olwyn Mooney ◽  
Alicia Salamanca-Sanabria ◽  
Chi Tak Lee ◽  
Simon Farrell ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Waiting List ◽  
Web Based ◽  
Randomized Controlled ◽  
Automated Support ◽  
Pilot Randomized Controlled Trial

BACKGROUND College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. OBJECTIVE This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. METHODS A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. RESULTS All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. CONCLUSIONS Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034 INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.invent.2019.100254

scholarly journals Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: The REduction of STress (REST) study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Luisa Weiner ◽  
Fabrice Berna ◽  
Nathalie Nourry ◽  
François Severac ◽  
Pierre Vidailhet ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Perceived Stress ◽  
Healthcare Workers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Healthcare Systems ◽  
Randomized Controlled

Abstract Background: The acknowledgement of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats, and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the ‘My Health too’ CBT program – a program we have developed for healthcare workers facing the pandemic -- on immediate perceived stress, and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy). Methods: Powered for non-inferiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels >16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores. Secondary outcomes include depression, insomnia, and PTSD symptoms, self-reported resilience and rumination, as well as credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks) and at 3-month and 6-month follow-up. Discussion: This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers’ mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis. Trial registration: NCT04362358, registered April 24, 2020.

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