Feasibility and preliminary efficacy of web-based and mobile interventions for common mental health problems in working adults: a multi-arm randomised pilot trial (Preprint)

2021 ◽  
Author(s):  
Marcos Economides ◽  
Heather Bolton ◽  
Rhian Male ◽  
Kate Cavanagh
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Self Report ◽  
Secondary Outcome ◽  
Control Group ◽  
Study Methods ◽  
Definitive Trial ◽  
Working Adults ◽  
Secondary Outcomes

BACKGROUND There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups. OBJECTIVE This study aimed to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, that incorporates evidence-based practices such as cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). Three brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, were evaluated. The primary aim was to determine the feasibility of the study methods and interventions in preparation for a definitive randomised controlled trial (RCT). METHODS The study employed a fully remote, parallel, multi-arm, external pilot RCT, with three intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity, who were recruited from an online participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included four self-report measures of mental health and wellbeing, completed at baseline (t0), post-intervention (t1) and 1-month follow-up (t2). Secondary outcomes were analysed via linear mixed effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated. RESULTS Data were collected between January to March 2021. A total of 383 working adult participants meeting trial eligibility were randomised, of which 356 (93.0%) were retained at t2. Objective engagement data showed that 67.8% of all participants randomised to an intervention arm completed their intervention. 87.1% of participants reported being “satisfied” or “very satisfied” with their intervention, and 87.1% rated the quality of their intervention as “good” or “excellent”. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedge’s g effect sizes for the pooled interventions ranging from 0.25 [95% CI 0.05-0.46] to 0.43 [95% CI 0.23-0.64]. All improvements were maintained at t2. CONCLUSIONS The study methods were feasible and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments are noted. Preliminary efficacy findings suggest the study interventions may result in improved mental health outcomes when offered to working adults. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 80309011; http://www.isrctn.com/ISRCTN80309011.

Testing the Effects of the Shamiri Intervention and its Components on Anxiety, Depression, Wellbeing, and Academic Functioning in Kenyan Adolescents: Study Protocol for a Five-Arm Randomized Controlled Trial

2021 ◽  
Author(s):  
Katherine E. Venturo-Conerly ◽  
Tom L Osborn ◽  
Akash R Wasil ◽  
Huong Le ◽  
Emily Corrigan ◽  
...  
Keyword(s):  
Mental Health ◽  
Academic Performance ◽  
Controlled Trial ◽  
Growth Mindset ◽  
Anxiety Symptoms ◽  
Control Group ◽  
Randomized Controlled ◽  
Multi Level ◽  
Secondary Outcomes ◽  
Over Time

Background: Treatments for youth mental disorders are a public health priority, especially in sub-Saharan Africa (SSA), where treatment options remain limited due to high cost, elevated stigma, and lack of trained mental health professionals. Brief, accessible, and non-stigmatizing community-based interventions delivered by lay-providers may help address treatment needs in SSA. One such intervention, the Shamiri Intervention, consisting of three elements (growth mindset, gratitude, and value affirmation) has been tested in randomized controlled trials with school-going Kenyan adolescents. This three-element Shamiri Intervention has been shown to significantly reduce depression and anxiety symptoms and improve social support and academic performance relative to a control group. In this trial, we aim to investigate the effects of each element of the Shamiri Intervention.Methods: In this five-arm randomized controlled trial, we will test each of the intervention components (growth mindset, gratitude, and value affirmation) against the full Shamiri Intervention and against a study-skills control intervention. Students (Nplanned=1288) at participating secondary schools who are interested in participating in this universal intervention will be randomized in equal numbers into the five groups. The students will meet in groups of 8-15 students led by local high school graduate lay-providers. These lay-providers will receive 10 hours of training, plus expert supervision once a week throughout the intervention delivery. Multi-level models will be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes in each intervention group to the control group. Multi-level models will also be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes of those in the single-element interventions compared to the full Shamiri Intervention. Finally, effect sizes (calculated as mean gain scores) will be used to compare all groups on all measures. Discussion: This trial will shed light on the mechanisms and outcomes targeted by each individual intervention, helping prioritize which mental health interventions are most important to disseminate.

scholarly journals Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041121
Author(s):  
Yago Tavares Pinheiro ◽  
Germanna Medeiros Barbosa ◽  
Hilmaynne Renaly Fonseca Fialho ◽  
César Augusto Medeiros Silva ◽  
Jaciara de Oliveira Anunciação ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Older Women ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Group Differences ◽  
Control Group ◽  
Kinesio Taping ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

scholarly journals The Improvement of Emotion and Attention Regulation after a 6-Week Training of Focused Meditation: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Carolina Baptista Menezes ◽  
Maria Clara de Paula Couto ◽  
Luciano G. Buratto ◽  
Fátima Erthal ◽  
Mirtes G. Pereira ◽  
...  
Keyword(s):  
Mental Health ◽  
Emotional Processing ◽  
Controlled Trial ◽  
Load Condition ◽  
Self Report ◽  
Control Group ◽  
Wait List ◽  
Attention Regulation ◽  
Attentional Load ◽  
Dose Response Effect

Self-regulatory trainings can be an effective complementary treatment for mental health disorders. We investigated the effects of a six-week-focused meditation training on emotion and attention regulation in undergraduates randomly allocated to a meditation, a relaxation, or a wait-list control group. Assessment comprised a discrimination task that investigates the relationship between attentional load and emotional processing and self-report measures. For emotion regulation, results showed greater reduction in emotional interference in the low attentional load condition in meditators, particularly compared to relaxation. Only meditators presented a significant association between amount of weekly practice and the reduction in emotion interference in the task and significantly reduced image ratings of negative valence and arousal, perceived anxiety and difficulty during the task, and state and trait-anxiety. For attention regulation, response bias during the task was analyzed through signal detection theory. After training, meditation and relaxation significantly reduced bias in the high attentional load condition. Importantly, there was a dose-response effect on general bias: the lowest in meditation, increasing linearly across relaxation and wait-list. Only meditators reduced omissions in a concentrated attention test. Focused meditation seems to be an effective training for emotion and attention regulation and an alternative for treatments in the mental health context.

Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

2021 ◽  
Author(s):  
Krämer Rico
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Online Intervention ◽  
Self Report ◽  
Secondary Outcome ◽  
Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Individualized Homeopathic Medicines for Cutaneous Warts

Homeopathy ◽  
2021 ◽  
Author(s):  
Samit Dey ◽  
Shifa Hashmi ◽  
Sangita Saha ◽  
Mahakas Mandal ◽  
Abdur Rahaman Shaikh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Attrition Rate ◽  
Effect Sizes ◽  
Secondary Outcome ◽  
Group Differences ◽  
Practice Research ◽  
Double Blind ◽  
Definitive Trial ◽  
Cutaneous Warts

Abstract Background Though frequently used in practice, research studies have shown inconclusive benefits of homeopathy in the treatment of warts. We aimed to assess the feasibility of a future definitive trial, with preliminary assessment of differences between effects of individualized homeopathic (IH) medicines and placebos in treatment of cutaneous warts. Methods A double-blind, randomized, placebo-controlled trial (n = 60) was conducted at the dermatology outpatient department of D.N. De Homoeopathic Medical College and Hospital, West Bengal. Patients were randomized to receive either IH (n = 30) or identical-looking placebo (n = 30). Primary outcome measures were numbers and sizes of the warts; secondary outcome was the Dermatology Life Quality Index (DLQI) questionnaire measured at baseline, and every month up to 3 months. Group differences and effect sizes were calculated on the intention-to-treat sample. Results Attrition rate was 11.6% (IH, 3; placebo, 4). Intra-group changes were significantly greater (all p < 0.05, Friedman tests) in IH than placebo. Inter-group differences were statistically non-significant (all p > 0.05, Mann-Whitney U tests) with small effect sizes—both in the primary outcomes (number of warts after 3 months: IH median [inter-quartile range; IQR] 1 [1, 3] vs. placebo 1 [1, 2]; p = 0.741; size of warts after 3 months: IH 5.6 mm [2.6, 40.2] vs. placebo 6.3 [0.8, 16.7]; p = 0.515) and in the secondary outcomes (DLQI total after 3 months: IH 4.5 [2, 6.2] vs. placebo 4.5 [2.5, 8]; p = 0.935). Thuja occidentalis (28.3%), Natrum muriaticum (10%) and Sulphur (8.3%) were the most frequently prescribed medicines. No harms, homeopathic aggravations, or serious adverse events were reported. Conclusion As regards efficacy, the preliminary study was inconclusive, with a statistically non-significant direction of effect favoring homeopathy. The trial succeeded in showing that an adequately powered definitive trial is both feasible and warranted. Trial Registration CTRI/2019/10/021659; UTN: U1111–1241–7340

scholarly journals SOLACE: A Psychosocial Stigma Protection Intervention to Improve the Mental Health of Parents of Autistic Children—A Feasibility Randomised Controlled Trial

2020 ◽  
Vol 50 (12) ◽  
pp. 4477-4491 ◽  
Author(s):  
Annemarie Lodder ◽  
Chris Papadopoulos ◽  
Gurch Randhawa
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Autistic Children ◽  
Self Compassion ◽  
Group Interviews ◽  
Randomised Controlled

AbstractThis study presents findings from a feasibility trial, testing an 8-week psychosocial stigma protection intervention (SOLACE) designed to improve the mental health of parents of autistic children. Seventeen parents were stratified then randomly assigned to either SOLACE (n = 9) or control group (n = 8). Retention and adherence rates were excellent with minimal missing data suggesting SOLACE had good acceptability and feasibility. Quantitative analysis revealed that mental health scores had significantly improved for those who took part in SOLACE compared to no significant changes for control group participants. In addition, changes in secondary outcome measures (e.g. stigma, self-esteem and self-compassion) were in favour of SOLACE. Focus group interviews revealed that SOLACE was acceptable to parents. Results suggest that a full randomised controlled trial is warranted.

scholarly journals An App-Based Intervention for Adolescents Exposed to Cyberbullying in Norway: Protocol for a Randomized Controlled Trial

10.2196/31789 ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. e31789
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Evaluation Studies ◽  
Well Being ◽  
Mobile App ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled

Background Adolescents exposed to negative online events are at high risk to develop mental health problems. Little is known about what is effective for treatment in this group. NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway. Objective The aim of this paper is to provide a description of the content of the intervention and about a randomized controlled trial that will be conducted to examine the effectiveness of NettOpp. This protocol is written in accordance with the Spirit 2013 Checklist. Methods An effectiveness study with a follow-up examination after 3 months will be conducted to evaluate the mobile app. Adolescents will be recruited through schools and will be randomly assigned to the intervention (NettOpp) group and a waiting-list control group. The adolescents (aged 11 to 16 years) will respond to self-report questionnaires on the internet. Primary outcomes will be changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen. Results Recruitment will start in January 2022. The results from this study will be available in 2023. Conclusions There are few published evaluation studies on app-based interventions. This project and its publications will contribute new knowledge to the field. Trial Registration ClinicalTrials.gov NCT04176666; https://clinicaltrials.gov/ct2/show/NCT04176666 International Registered Report Identifier (IRRID) PRR1-10.2196/31789

scholarly journals A three-arm randomised controlled trial to evaluate the efficacy of a positive psychology and social networking intervention in promoting mental health among HIV-infected men who have sex with men in China

2021 ◽  
Vol 30 ◽  
Author(s):  
J. Li ◽  
P. K. H. Mo ◽  
C. W. Kahler ◽  
J. T. F. Lau
Keyword(s):  
Mental Health ◽  
Health Promotion ◽  
Negative Affect ◽  
Social Networking ◽  
Controlled Trial ◽  
Mental Health Promotion ◽  
Control Group ◽  
Secondary Outcomes ◽  
Sex With Men ◽  
Randomised Controlled

Abstract Aims There is a lack of mental health promotion and treatment services targeting HIV-positive men who have sex with men (HIVMSM) in China. The aim of this study was to evaluate the mental health promotion efficacy of an online intervention that combined Three Good Things (TGT) with electronic social networking (TGT-SN) and an intervention that used TGT only (TGT-only), compared with a control group. Methods We conducted a randomised controlled trial among HIVMSM in Chengdu, China. The participants were randomly assigned to the TGT-SN, TGT-only, and control groups. The participants in the TGT-SN group were divided into five social network groups and asked to post brief messages to the group about three good things that they had experienced and for which they felt grateful. The participants in the TGT-only group were only required to write down their three good things daily without sharing them with others. The control group received information about mental health promotion once a week for a month. The primary outcome was probable depression. Secondary outcomes were anxiety, positive and negative affect, gratitude, happiness and social support. These outcomes were assessed at baseline, 1, 3, 6 and 12 months after the intervention. Repeated-measures analyses were conducted using generalised estimation equations. The study was registered with the Chinese Clinical Trial Registry (ChiCTR-TRC-13003252). Results Between June 2013 and May 2015, 404 participants were enrolled and randomly assigned to either the TGT-SN (n = 129), TGT-only (n = 139) or control group (n = 136). The main effects of TGT-SN (adjusted odds ratio (aOR) = 0.75, 95% CI 0.52–1.09; p = 0.131) and TGT-only (aOR = 0.83, 95% CI 0.57–1.21; p = 0.332) in reducing depression were statistically non-significant. The participants of the TGT-SN group showed significantly lower anxiety symptoms (aOR = 0.62, 95% CI 0.43–0.89; p = 0.009) and negative affect (β = −1.62, 95% CI 2.98 to −0.26; p = 0.019) over time compared with those of the control group. No significant main effect was found for any secondary outcomes for the TGT-only group. Conclusions The novel intervention combining the TGT exercise with electronic social networking was found effective in reducing anxiety and negative affect among HIVMSM.

scholarly journals Testing the effects of the Shamiri Intervention and its components on anxiety, depression, wellbeing, and academic functioning in Kenyan adolescents: study protocol for a five-arm randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Katherine E. Venturo-Conerly ◽  
Tom L. Osborn ◽  
Akash R. Wasil ◽  
Huong Le ◽  
Emily Corrigan ◽  
...  
Keyword(s):  
Mental Health ◽  
Academic Performance ◽  
Controlled Trial ◽  
Growth Mindset ◽  
Anxiety Symptoms ◽  
Control Group ◽  
Randomized Controlled ◽  
Multi Level ◽  
Secondary Outcomes ◽  
Over Time

Abstract Background Treatments for youth mental disorders are a public health priority, especially in sub-Saharan Africa (SSA), where treatment options remain limited due to high cost, elevated stigma, and lack of trained mental health professionals. Brief, accessible, and non-stigmatizing community-based interventions delivered by lay providers may help address treatment needs in SSA. One such intervention, the Shamiri Intervention, consisting of three elements (growth mindset, gratitude, and value affirmation) has been tested in randomized controlled trials with school-going Kenyan adolescents. This three-element Shamiri Intervention has been shown to significantly reduce depression and anxiety symptoms and improve social support and academic performance relative to a control group. In this trial, we aim to investigate the effects of each element of the Shamiri Intervention. Methods In this five-arm randomized controlled trial, we will test each of the intervention components (growth mindset, gratitude, and value affirmation) against the full Shamiri Intervention and against a study skills control intervention. Students (Nplanned = 1288) at participating secondary schools who are interested in participating in this universal intervention will be randomized in equal numbers into the five groups. The students will meet in groups of 8–15 students led by local high school graduate lay providers. These lay providers will receive a brief training, plus expert supervision once a week throughout the intervention delivery. Multi-level models will be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes in each intervention group to the control group. Multi-level models will also be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes of participants in the single-element interventions compared to the full Shamiri Intervention. Finally, effect sizes (calculated as mean gain scores) will be used to compare all groups on all measures. Discussion This trial will shed light on the mechanisms and outcomes targeted by each individual intervention, helping prioritize which mental health interventions are most important to disseminate. Trial registration PACTR Trial ID: PACTR202104716135752. Approved on 4/19/2021.

scholarly journals An App-Based Intervention for Adolescents Exposed to Cyberbullying in Norway: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Evaluation Studies ◽  
Well Being ◽  
Mobile App ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Adolescents exposed to negative online events are at high risk to develop mental health problems. Little is known about what is effective for treatment in this group. NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway. OBJECTIVE The aim of this paper is to provide a description of the content of the intervention and about a randomized controlled trial that will be conducted to examine the effectiveness of NettOpp. This protocol is written in accordance with the Spirit 2013 Checklist. METHODS An effectiveness study with a follow-up examination after 3 months will be conducted to evaluate the mobile app. Adolescents will be recruited through schools and will be randomly assigned to the intervention (NettOpp) group and a waiting-list control group. The adolescents (aged 11 to 16 years) will respond to self-report questionnaires on the internet. Primary outcomes will be changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen. RESULTS Recruitment will start in January 2022. The results from this study will be available in 2023. CONCLUSIONS There are few published evaluation studies on app-based interventions. This project and its publications will contribute new knowledge to the field. CLINICALTRIAL ClinicalTrials.gov NCT04176666; https://clinicaltrials.gov/ct2/show/NCT04176666 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/31789

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