scholarly journals Efficacy of an Internet-Based Intervention for Subclinical Depression (MoodBox) in China: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 11 ◽  
Author(s):  
Xu Chen ◽  
Xiaolong Zhang ◽  
Xuequan Zhu ◽  
Gang Wang
Keyword(s):  
Clinical Trial ◽  
Intervention Program ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Alternative Treatment Option ◽  
Subclinical Depression

Background: Subclinical depression is a prevalent mental health problem and increases the incidence of the onset of major mood disorders, such as major depressive disorder (MDD). Psychological interventions have been proved to be effective for reducing depressive symptoms for people with subclinical depression and can prevent the onset of MDD. However, people have limited access to face-to-face psychotherapy. Internet-based psychological intervention is an alternative treatment option. The aim of the study is to evaluate the efficacy of MoodBox, an online psychological intervention program, for subclinical depression.Methods: This study is a multicenter, randomized, controlled, non-blinded superiority study with three parallel groups. A total of 435 first-year university students with subclinical depression will be recruited. Eligible participants will be randomly assigned to the MoodBox group, the online psychoeducation group, and the naturalistic observation group at a ratio of 1:1:1. The intervention period is 8 weeks, and participants will be continuously followed up for 1 year. The primary outcome of the study is the efficacy of the intervention, defined as measured by the Patient Health Questionnaire (PHQ-9).Discussion: This is the first study to innovatively develop and test an intervention to improve psychological well-being and decrease the incidence of MDD in a subclinical depression population in China. Once proven effective and acceptable, MoodBox could be potentially integrated into the routine clinical service to facilitate the management for people with subclinical depression.Clinical Trial Registration: The trial is registered with the Chinese Clinical Trial Registry on 21 July 2020 (No. ChiCTR2000034826).

scholarly journals Acupuncture as an Adjunctive Treatment for Post-stroke Epilepsy: Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Yang Zhang ◽  
Meidan Zhao ◽  
Baozhen Zhang ◽  
Kai Zhang ◽  
Zhen Zhou
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Adjunctive Treatment ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Routine Treatment ◽  
Post Stroke ◽  
Randomized Controlled

Background: Acupuncture has been clinically used to treat epilepsy after stroke. However, most of the current clinical studies are observational studies, and there are few well-designed randomized controlled trials (RCTs). Hence, we designed a multicentre RCT to assess the advantages and efficacy of acupuncture for post-stroke epilepsy (PSE).Methods/Design: This is a two-arm, parallel, participants-blinded and assessor-blinded and multicentre RCT. A total of 120 patients with PSE aged from 18 to 75 years will be randomly assigned to two groups (routine treatment plus acupuncture group and routine treatment plus sham acupuncture group) at a 1:1 ratio. The participants will perform acupuncture or sham acupuncture treatment three times a week and be ongoing 8-week treatment. The primary endpoint is the proportion of seizure-free patients. A safety profile will be established. We will record adverse events for the safety evaluation.Discussion: The study will provide high-quality clinical evidence on the effectiveness and safety of acupuncture for treating patients with epilepsy after stroke.Clinical Trial Registration: Chinese Clinical Trial Registry, identifier: ChiCTR2100046114.

scholarly journals The Effectiveness of Traditional Chinese Yijinjing Qigong Exercise for the Patients With Knee Osteoarthritis on the Pain, Dysfunction, and Mood Disorder: A Pilot Randomized Controlled Trial

2022 ◽  
Vol 8 ◽  
Author(s):  
Shuaipan Zhang ◽  
Guangxin Guo ◽  
Xing Li ◽  
Fei Yao ◽  
Zhiwei Wu ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Well Being ◽  
Functional Mobility ◽  
Exercise Session ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration ◽  
Randomized Controlled

Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA.Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data.Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P > 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments.Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required.Clinical Trial Registration:https://www.chictr.org.cn/edit.aspx?pid=60357&htm=4, ChiCTR2000037256.

scholarly journals A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the ¡Alégrate! Randomized Controlled Trial

10.2196/17721 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e17721
Author(s):  
Rosalba Hernandez ◽  
Michael Cohn ◽  
Alison Hernandez ◽  
Martha Daviglus ◽  
Lizet Martinez ◽  
...  
Keyword(s):  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Spanish Language ◽  
Psychological Well Being ◽  
Web Based ◽  
Spanish Speaking ◽  
Randomized Controlled ◽  
Latino People ◽  
Positive Psychological Intervention

Background Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. Objective The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. Methods A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. Results Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. Conclusions Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. Trial Registration ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057 International Registered Report Identifier (IRRID) PRR1-10.2196/17721

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Tianwang Buxin Granules Influence the Intestinal Flora in Perimenopausal Insomnia

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Xiqian Yang ◽  
Hesong Xiao ◽  
Yi Zeng ◽  
Liangliang Huang ◽  
Ke Ji ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Intestinal Flora ◽  
World Health ◽  
Control Group ◽  
Metagenomic Sequencing ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Faecalibacterium Prausnitzii ◽  
Health Organization

Study Objectives. To study the relationship between perimenopausal insomnia (PI) and intestinal flora and the potential mechanism of Tianwang Buxin granules (TWBXG) in exerting its clinical efficacy. Methods. The subjects included 13 PI patients from the Hubei Provincial Hospital of TCM, Hubei University of TCM, and Wuhan Traditional Chinese Medicine Hospital, and the corresponding noninsomniac spouses of the patients were selected as controls. TWBXG was continuously administered for 4 weeks. The feces of PI patients and their noninsomniac spouses before and after treatment with TWBXG were collected. The intestinal flora composition of each group was detected by metagenomic sequencing, and the efficacy of TWBXG was evaluated by the PSQI scale. Results. Compared with the control group, the model group showed an increase in the abundance of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum, while those of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii were decreased. Compared with pretreatment, the PSQI score was significantly reduced ( P < 0.05 ), the abundance of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii increased, and that of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum decreased after treatment. However, there was still a certain gap in the abundance of related flora in the treatment group compared with the control. Conclusion. PI is associated with disturbances in the intestinal flora and is mainly related to the disorders of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, Blautia obeum, Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii. TWBXG can effectively treat PI, and its effect may be achieved by regulating the disordered intestinal flora. Clinical Trials. The study was registered in the Chinese clinical trial registry and approved by the World Health Organization clinical trial registration platform (Effects of the modified Tianwang Buxin granule and modified Tianwang Buxin decoction pieces on insomnia: a randomized, controlled trial, ChiCTR-IPR-17011549).

scholarly journals Efficacy and safety of Qi-Jing Hui-Xin Decoction in the treatment of coronary microvascular angina: Study protocol for a randomized, controlled, multi-center clinical trial

2021 ◽  
Author(s):  
Yuanlong Sun ◽  
Chengxin Huang ◽  
Li Huo ◽  
Yin Li ◽  
Jun Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Efficacy ◽  
Study Protocol ◽  
Clinical Studies ◽  
Controlled Trial ◽  
Clinical Importance ◽  
Adjunctive Treatment ◽  
Clinical Trial Registry ◽  
Microvascular Angina ◽  
Randomized Controlled

Abstract Background: With the increased understanding of heart disease, microvascular angina (MVA) is receiving greater attention from clinicians. Studies have shown that patients with MVA have significantly higher major cardiovascular events and all-cause mortality than the control population, and the search for effective treatments is of great clinical importance. Both basic and clinical studies have shown that Qi-Jing Hui-Xin Decoction (QJHX) can relieve angina symptoms and improve clinical efficacy, but there is a lack of high-quality clinical studies to provide a research basis. This article introduces the evaluation protocol of QJHX for the adjunctive treatment of MVA.Methods/design: This is a prospective randomized controlled trial. The trial will enroll 150 patients with MVA. On the basis of Western drug treatment, patients will be randomized into two groups, and the experimental group will receive QJHX treatment for 12 weeks, and follow up at 24 week. The primary indicators are the clinical efficacy of angina pectoris and the evidence of Traditional Chinese Medicine (TCM) efficacy. Secondary indicators are Seattle Angina Scale score, serum lipid levels, electrocardiogram and echocardiogram diagnosis. Additional indicators are endothelial function and immunoinflammatory factors. Adverse events will be monitored throughout the trial.Discussion: Integrated traditional Chinese and Western medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of adding QJHX on the basis of standardized Western medications. The results of the trial will provide high-level clinical research-based evidence for the application of QJHX in MVA.Trial registration: This study protocol was registered on 28 October 2019. The registration number is ChiCTR1900027015 at the Chinese Clinical Trial Registry.

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial

2021 ◽  
pp. 1-7
Author(s):  
Usha K. Misra ◽  
Jayantee Kalita ◽  
Varun K. Singh ◽  
Aditya Kapoor ◽  
Abhilasha Tripathi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Myasthenia Gravis ◽  
Controlled Trial ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Secondary Endpoints

<b><i>Introduction:</i></b> There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. <b><i>Methods:</i></b> In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by &#x3e;50% improvement in these outcome parameters. <b><i>Results:</i></b> Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (<i>p =</i> 0.02). The secondary endpoints, distance covered in 6MWT (<i>p =</i> 0.007), were also better in the exercise arm without any adverse event. <b><i>Conclusion:</i></b> Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. <b><i>Clinical Trial Registration:</i></b> The clinical trial registration number is CTRI/2019/11/021869.

scholarly journals A RANDOMIZED CONTROLLED TRIAL ON THE ISLAMIC-BASED PROGRAM USING FAMILY APPROACHES IN PREVENTING ADOLESCENTS’ SMOKING BEHAVIOR IN INDONESIA: A STUDY PROTOCOL

2020 ◽  
Vol 6 (4) ◽  
pp. 136-140
Author(s):  
Fithria Fithria ◽  
Muhammad Adlim ◽  
Syarifah Rauzatul Jannah ◽  
Teuku Tahlil
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Intervention Program ◽  
Controlled Trial ◽  
Smoking Behavior ◽  
Smoking Prevention ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Family Approach

Background: Smoking is a significant problem especially among Indonesian adolescents. A number of smoking prevention programs have been developed and implemented, but most of them do not work significantly for the Indonesian adolescents who are mostly Muslim.Objective: The aim of this article is to outline a study protocol for measuring the effects of Islamic-based program using family approaches on the prevention of adolescents’ smoking behavior.Methods: The study will use a cluster randomized controlled trial conducted in three junior high schools, in Aceh Province, Indonesia. A total of 150 students will be involved in this study, where each school will be represented by 50 students. Each school group will be given the respective treatments. The first group will receive health-based intervention program, the second group will receive Islamic-based intervention program, and the last group will act as a control group receiving no intervention. The outcomes include the knowledge about smoking, attitudes toward smoking, smoking intention and smoking behavior of the adolescents. All outcomes will be measured using validated questionnaires.Discussion: If the Islamic-based intervention using family approach is effective, then this approach could be implemented not only in Indonesia but also in other countries with the same social characteristics.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN 12620000465954

scholarly journals A Randomised Trial: BIS-Guided Anesthesia Decreases The Incidence of Delayed Neurocognitive Recovery And Postoperative Neurocognitive Disorder But Not Postoperative Delirium

2021 ◽  
Author(s):  
Xingqu Chen ◽  
Linji Li ◽  
Li Yang ◽  
Aijiao Li ◽  
Miao Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Postoperative Cognitive Dysfunction ◽  
Control Group ◽  
Neurocognitive Disorder ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Significant Difference

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD).Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P＜0.001, at 7th day) (1% vs 21.1%, P＜0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P＜0.001). The postoperative hospitalisation time （9.99 vs 12.41, P＜0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463. http://www.chictr.org.cn/showproj.aspx?proj=33065

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