Effectiveness of a Mobile Device–Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial

Background Caring for children with cancer can be a stressful experience for parents and may have negative effects on their physical and psychological well-being. Although evidence has shown that resilience is associated with positive psychological well-being, few interventions have been specifically designed to enhance the resilience of parents of children with cancer. Objective The aim of this study is to examine the effectiveness of a mobile device–based resilience training program in reducing depressive symptoms and enhancing resilience and quality of life (QoL) in parents of children with cancer. Methods Parents of children diagnosed with cancer were recruited from the pediatric oncology wards of 3 tertiary hospitals in China. The participants were randomly assigned to either the experimental group (52/103, 50.5%) to undergo an 8-week mobile device–based resilience training program or to the control group (51/103, 49.5%) to receive an 8-week program of placebo information. The study outcomes included resilience, depressive symptoms, and QoL, as measured by the Connor–Davidson Resilience Scale, the Self-Rating Depression Scale, and the Short Form of the 6-Dimension Health Survey, respectively. All data were collected at baseline and at 2 and 6 months of follow-up. The data analysis followed the intention-to-treat principle. A generalized estimating equation was used to examine the effects of the intervention. Results The participants were mostly female (72/103, 69.9%), and their mean age was 33.6 (SD 5.2) years. The participants in the experimental group showed significantly higher levels of resilience (mean 67.96, SD 15.8 vs mean 58.27, SD 19.0; P<.001) and lower levels of depressive symptoms (mean 40.17, SD 9.9 vs mean 46.04, SD 10.9; P<.001) than those in the control group at 6 months of follow-up. The intervention showed statistically significant effects in improving resilience (β=6.082; P=.01) and decreasing depressive symptoms (β=−2.772; P=.04) relative to the control group. The QoL score in the experimental group was higher than that in the control group at 6 months of follow-up (mean 0.79, SD 0.2 vs mean 0.76, SD 0.3; P=.07); however, no statistically significant intervention effect was detected (β=.020; P=.38). Conclusions The mobile device–based resilience training program effectively enhanced resilience and alleviated depressive symptoms in parents of children with cancer. It is highly recommended that health care professionals incorporate this resilience training program when providing psychological care to parents of children with cancer. Trial Registration Clinical.Trials.gov NCT04038242; http://clinicaltrials.gov/ct2/show/NCT04038242

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Effectiveness of a Mobile Device–Based Resilience Training Program in Reducing Depressive Symptoms and Enhancing Resilience and Quality of Life in Parents of Children With Cancer: Randomized Controlled Trial (Preprint)

10.2196/preprints.27639 ◽

2021 ◽

Author(s):

Yuanhui Luo ◽

Wei Xia ◽

Ankie Tan Cheung ◽

Laurie Long Kwan Ho ◽

Jingping Zhang ◽

...

Keyword(s):

Depressive Symptoms ◽

Training Program ◽

Mobile Device ◽

Well Being ◽

Control Group ◽

Children With Cancer ◽

Resilience Training ◽

Experimental Group

BACKGROUND Caring for children with cancer can be a stressful experience for parents and may have negative effects on their physical and psychological well-being. Although evidence has shown that resilience is associated with positive psychological well-being, few interventions have been specifically designed to enhance the resilience of parents of children with cancer. OBJECTIVE The aim of this study is to examine the effectiveness of a mobile device–based resilience training program in reducing depressive symptoms and enhancing resilience and quality of life (QoL) in parents of children with cancer. METHODS Parents of children diagnosed with cancer were recruited from the pediatric oncology wards of 3 tertiary hospitals in China. The participants were randomly assigned to either the experimental group (52/103, 50.5%) to undergo an 8-week mobile device–based resilience training program or to the control group (51/103, 49.5%) to receive an 8-week program of placebo information. The study outcomes included resilience, depressive symptoms, and QoL, as measured by the Connor–Davidson Resilience Scale, the Self-Rating Depression Scale, and the Short Form of the 6-Dimension Health Survey, respectively. All data were collected at baseline and at 2 and 6 months of follow-up. The data analysis followed the intention-to-treat principle. A generalized estimating equation was used to examine the effects of the intervention. RESULTS The participants were mostly female (72/103, 69.9%), and their mean age was 33.6 (SD 5.2) years. The participants in the experimental group showed significantly higher levels of resilience (mean 67.96, SD 15.8 vs mean 58.27, SD 19.0; P<.001) and lower levels of depressive symptoms (mean 40.17, SD 9.9 vs mean 46.04, SD 10.9; P<.001) than those in the control group at 6 months of follow-up. The intervention showed statistically significant effects in improving resilience (β=6.082; P=.01) and decreasing depressive symptoms (β=−2.772; P=.04) relative to the control group. The QoL score in the experimental group was higher than that in the control group at 6 months of follow-up (mean 0.79, SD 0.2 vs mean 0.76, SD 0.3; P=.07); however, no statistically significant intervention effect was detected (β=.020; P=.38). CONCLUSIONS The mobile device–based resilience training program effectively enhanced resilience and alleviated depressive symptoms in parents of children with cancer. It is highly recommended that health care professionals incorporate this resilience training program when providing psychological care to parents of children with cancer. CLINICALTRIAL Clinical.Trials.gov NCT04038242; http://clinicaltrials.gov/ct2/show/NCT04038242

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Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

BMC Psychology ◽

10.1186/s40359-021-00547-0 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Somayeh Makaremnia ◽

Marieh Dehghan Manshadi ◽

Zahra Khademian

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Training Program ◽

Randomized Clinical Trial ◽

Thalassemia Major ◽

Trial Registration ◽

Control Group ◽

Positive Thinking ◽

Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

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Effectiveness of Cognitive-Behavioral Therapy (CBT) on Quality of Life (QOL) and Worry in Patients with Generalized Anxiety Disorder (GAD)

International Journal of Indian Psychology ◽

10.25215/0202.021 ◽

2015 ◽

Vol 2 (2) ◽

Author(s):

Sheida Jabalameli ◽

Hamid Taher Neshat Doost ◽

Mohammad Bagher Kajbaf ◽

Hossein Molavi

Keyword(s):

Quality Of Life ◽

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Behavioral Therapy ◽

Control Group ◽

Generalized Anxiety ◽

The Mean ◽

Experimental Group

Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders. It has been reported that psychological treatments like Cognitive-Behavioral Therapy (CBT) is effective for patients with GAD. The purpose of the present research was to investigate the effectiveness of CBT on Quality of Life (QOL) and worry in patients with GAD. A sample of 30 patients with GAD who had been referred to psychiatry offices in Isfahan, Iran were selected and assigned into an experimental group (n=15) and a control group (n=15) randomly. The experimental group received CBT in 8 weekly sessions. All participants completed the World Health Organization Quality Of Life-Brief (WHOQOL-BREF) questionnaire and the Penn State Worry Questionnaire (PSWQ) at pretest, posttest and follow up. The results of MANCOVA showed that the mean scores of QOL in the experimental group was significantly higher than the control group at the posttest and follow up (P<0.05) and the mean scores of worry in the experimental group was significantly lower than the control group at the posttest and follow up (P<0.05) It is concluded that CBT can be applied for the patients with GAD as a useful psychological treatment. In general, CBT can improve QOL and decrease worry in patients with GAD.

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The Effectiveness of Mindfulness Training on Quality of Perceptual Marital Relationship and Psychological Well-being of Women with Addicted Wife

Revista Romaneasca pentru Educatie Multidimensionala ◽

10.18662/rrem/35 ◽

2018 ◽

Vol 10 (1.SP) ◽

pp. 34

Author(s):

Masoumeh GHARIBBOLUK ◽

Soghra HOSSEINZADEH

Keyword(s):

Marital Relationship ◽

Well Being ◽

Mindfulness Training ◽

Analysis Of Covariance ◽

Control Group ◽

Positive Thinking ◽

Psychological Well Being ◽

Quasi Experimental ◽

Experimental Group

Objective: The aim of the research was to investigate the effect of Mindfulness Training on Quality of Perceptual Marital Relationship and Psychological Well-being of Women with Addicted Wife.Methods: The research method was quasi-experimental with pretest- posttest and 3 months follow up, with a control group. Among the population of Women with Addicted Wife, twenty Women with Addicted Wife (10 persons in experimental group, 10 persons in control group) were selected by purposeful sampling method and were assigned in experimental and control groups. The experimental group received 8 session (2 hours for each) of positive thinking training. For data collection, Fletcher Perceived Quality of Marital Relationship Scale and Ryff Psychological Well-Being Questionnaire were used.Results: Multivariate analysis of covariance (MANCOVA) was used for analyzing the data. The results showed the Mindfulness Training was effective on the quality of marital relationship and psychological well-being among Women with Addicted Wife. Also, the training was effective in a 3 months follow up.Conclusion: Therefore, Mindfulness Training skills can be used in prevention actions.

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Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520923135 ◽

2020 ◽

Vol 34 (7) ◽

pp. 938-947 ◽

Cited By ~ 1

Author(s):

Mehdi Zemestani ◽

Sharmin Mozaffari

Keyword(s):

Emotion Regulation ◽

Depressive Symptoms ◽

Controlled Trial ◽

Psychological Flexibility ◽

Well Being ◽

Control Group ◽

Psychological Well Being ◽

Randomized Controlled ◽

Acceptance And Commitment ◽

Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

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Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v4 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

BMC Endocrine Disorders ◽

10.1186/s12902-020-00637-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Marjolein M. Iversen ◽

Jannicke Igland ◽

Hilde Smith-Strøm ◽

Truls Østbye ◽

Grethe S. Tell ◽

...

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Foot Ulcer ◽

Well Being ◽

Foot Ulcers ◽

Control Group ◽

Patient Reported ◽

Reported Health

Abstract Background Follow-up care provided via telemedicine (TM) is intended to be a more integrated care pathway to manage diabetes-related foot ulcers (DFU) than traditionally-delivered healthcare. However, knowledge of the effect of TM follow-up on PROMs including self-reported health, well-being and QOL in patients with DFUs is lacking and often neglected in RCT reports in general. Therefore, in this study of secondary outcomes from the DiaFOTo trial, the aim was to compare changes in self-reported health, well-being and QOL between patients with DFUs receiving telemedicine follow-up care in primary healthcare in collaboration with specialist healthcare, and patients receiving standard outpatient care. Methods The current study reports secondary endpoints from a cluster randomized controlled trial whose primary endpoint was ulcer healing time. The trial included 182 adults with diabetes-related foot ulcers (94/88 in the telemedicine/standard care groups) in 42 municipalities/districts, recruited from three clinical sites in Western Norway. Mean (SD) diabetes duration for the study population was 20.8 (15.0). The intervention group received care in the community in collaboration with specialist healthcare using an asynchronous telemedicine intervention. The intervention included an interactive web-based ulcer record and a mobile phone enabling counseling and communication between the community nurses and specialist healthcare; the control group received standard outpatient care. In total 156 participants (78/78) reported on secondary endpoints: self-reported health, well-being and quality of life evaluated by generic and disease-specific patient-reported outcome measures (e.g. Euro-QOL, the Hospital Anxiety and Depression Scale (HADS), Problem Areas in Diabetes (PAID), Neuropathy and Foot Ulcer–Specific Quality of Life Instrument (NeuroQOL)). Linear mixed-effects regression was used to investigate possible differences in changes in the scores between the intervention and control group at the end of follow-up. Results In intention to treat analyses, differences between treatment groups were small and non-significant for the health and well-being scale scores, as well as for diabetes-related distress and foot ulcer-specific quality of life. Conclusions There were no significant differences in changes in scores for the patient reported outcomes between the intervention and control group, indicating that the intervention did not affect the participants’ health, well-being and quality of life. Trial registration Clinicaltrials.gov, NCT01710774. Registered October 19th, 2012.

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Evaluation of the TSL® Program for Parents of Children With Cancer

Research on Social Work Practice ◽

10.1177/1049731516637121 ◽

2016 ◽

Vol 28 (2) ◽

pp. 146-153 ◽

Cited By ~ 2

Author(s):

Kwonho Choi ◽

Jae Yop Kim

Keyword(s):

Posttraumatic Growth ◽

Cortisol Level ◽

Control Group ◽

Children With Cancer ◽

Experimental Group

Objectives: This study aims to investigate the effects of the Thank you–Sorry–Love (TSL®) program on posttraumatic growth (PTG) and cortisol level in parents of children with cancer. Methods: A total of 15 mothers of children with cancer were randomly assigned to the experimental group ( n = 7) with the TSL intervention or a control group ( n = 8) without any intervention. PTG and cortisol level were checked 3 times at the pretest, posttest, and 10-week follow-up. Results: PTG scores were significantly different between the two groups at the posttest and the follow-up test. Cortisol level was only significantly different between the two groups at the posttest. Conclusions: The TSL program may be a possible intervention for parents of children with cancer.

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Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial (Preprint)

10.2196/preprints.17084 ◽

2019 ◽

Author(s):

I-Ching Hou ◽

Hsin-Yi Lin ◽

Shan-Hsiang Shen ◽

King-Jen Chang ◽

Hao-Chih Tai ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Self Management ◽

Control Group ◽

Life Questionnaire ◽

Management Support ◽

Experimental Group ◽

First Diagnosis

BACKGROUND There are over 2 million newly diagnosed patients with breast cancer worldwide with more than 10,000 cases in Taiwan each year. During 2017-2018, the National Yang-Ming University, the Taiwan University of Science and Technology, and the Taiwan Breast Cancer Prevention Foundation collaborated to develop a breast cancer self-management support (BCSMS) mHealth app for Taiwanese women with breast cancer. OBJECTIVE The aim of this study was to investigate the quality of life (QoL) of women with breast cancer in Taiwan after using the BCSMS app. METHODS After receiving a first diagnosis of breast cancer, women with stage 0 to III breast cancer, who were recruited from social networking sites or referred by their oncologists or oncology case managers, were randomized 1:1 into intervention and control groups. Intervention group subjects used the BCSMS app and the control group subjects received usual care. Two questionnaires—the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and the EORTC Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)—were distributed to subjects in both arms. Paper-based questionnaires were used at baseline; paper-based or Web-based questionnaires were used at 1.5-month and 3-month follow-up evaluations. All evaluations were self-assessed and anonymous, and participants were blinded to their allocation groups. Descriptive analysis, the Pearson chi-square test, analysis of variance, and the generalized estimating equation were used to analyze the data. Missing values, with and without multi-imputation techniques, were used for sensitivity analysis. RESULTS A total of 112 women were enrolled and randomly allocated to either the experimental group (n=53) or control group (n=59). The follow-up completion rate was 89.3% (100/112). The demographic data showed homogeneity between the two groups in age (range 50-64 years), breast cancer stage (stage II), marital status (married), working status (employed), and treatment status (receiving treatments). The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months. CONCLUSIONS This research provides support for using a mobile health care app to promote the QoL among women in Taiwan after a first diagnosis of breast cancer. The BCSMS app could be used to support disease self-management, and further evaluation of whether QoL is sustained is warranted. CLINICALTRIAL ClinicalTrials.gov NCT004174248; https://clinicaltrials.gov/ct2/show/NCT04174248

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Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/17084 ◽

2020 ◽

Vol 8 (3) ◽

pp. e17084 ◽

Cited By ~ 1

Author(s):

I-Ching Hou ◽

Hsin-Yi Lin ◽

Shan-Hsiang Shen ◽

King-Jen Chang ◽

Hao-Chih Tai ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Self Management ◽

Control Group ◽

Life Questionnaire ◽

Management Support ◽

Experimental Group ◽

First Diagnosis

Background There are over 2 million newly diagnosed patients with breast cancer worldwide with more than 10,000 cases in Taiwan each year. During 2017-2018, the National Yang-Ming University, the Taiwan University of Science and Technology, and the Taiwan Breast Cancer Prevention Foundation collaborated to develop a breast cancer self-management support (BCSMS) mHealth app for Taiwanese women with breast cancer. Objective The aim of this study was to investigate the quality of life (QoL) of women with breast cancer in Taiwan after using the BCSMS app. Methods After receiving a first diagnosis of breast cancer, women with stage 0 to III breast cancer, who were recruited from social networking sites or referred by their oncologists or oncology case managers, were randomized 1:1 into intervention and control groups. Intervention group subjects used the BCSMS app and the control group subjects received usual care. Two questionnaires—the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and the EORTC Breast Cancer-Specific Quality-of-Life Questionnaire (QLQ-BR23)—were distributed to subjects in both arms. Paper-based questionnaires were used at baseline; paper-based or Web-based questionnaires were used at 1.5-month and 3-month follow-up evaluations. All evaluations were self-assessed and anonymous, and participants were blinded to their allocation groups. Descriptive analysis, the Pearson chi-square test, analysis of variance, and the generalized estimating equation were used to analyze the data. Missing values, with and without multi-imputation techniques, were used for sensitivity analysis. Results A total of 112 women were enrolled and randomly allocated to either the experimental group (n=53) or control group (n=59). The follow-up completion rate was 89.3% (100/112). The demographic data showed homogeneity between the two groups in age (range 50-64 years), breast cancer stage (stage II), marital status (married), working status (employed), and treatment status (receiving treatments). The mean total QoL summary scores from the QLQ-C30 (83.45 vs 82.23, P=.03) and the QLQ-BR23 (65.53 vs 63.13, P=.04) were significantly higher among the experimental group versus the control group, respectively, at 3 months. Conclusions This research provides support for using a mobile health care app to promote the QoL among women in Taiwan after a first diagnosis of breast cancer. The BCSMS app could be used to support disease self-management, and further evaluation of whether QoL is sustained is warranted. Trial Registration ClinicalTrials.gov NCT004174248; https://clinicaltrials.gov/ct2/show/NCT04174248

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