• Title/Summary/Keyword: Ethical Validity

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A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial (여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜)

  • Seo, Young Kyung;Lee, Eun Hee;Kim, Hwan;Lee, Ji-yoon;Park, Chae Rin;Choi, Sunyoung;Jang, Eunsu;Kwon, Ojin;Kim, Hyungjun;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.1
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

Contact Frequency and Psychological Distance between Leaders: Job Distress and Mediation through Employees' Perceived Self-Leadership (리더와의 접촉빈도와 심리적 거리가 직무 디스트레스에 미치는 영향: 구성원이 인지하는 셀프리더십의 매개효과)

  • Yang, Hoe-Chang;Jeon, Jun-Ho;Park, Jong-Rok
    • Journal of Distribution Science
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    • v.12 no.6
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    • pp.41-48
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    • 2014
  • Purpose - This study aims to investigate a solution to reduce the negative reactions arising from the performance of duties or the job distress of workers in the service industry, because human resource statistics regarding workers in the service sector have been unreported, while concerns regarding exposure to emotional exertion and poor working conditions have been continuously increasing. Research design, data, and methodology - This study specifically focused on workers in highway service areas. It differs from previous studies because it involves the perspective of the person-organization fit and regards workers' cognition of leaders through the psychological distance toward the leader and the contact frequency between workers and leaders within the framework of the leader-individual fit. Moreover, this study highlights the role of the self-leadership of workers as an important factor that becomes manifested in the individual-level fit to the organization. Hence, this study investigates whether the positive role of the above factors, in turn, could reduce job distress. Workers from highway service areas in Gyeonggi-do province provided data; 141 valid questionnaires are collected. SPSS 19.0 and AMOS 19.0 were used to test the reliability and validity of constructs. Simple regression, multiple regression, and 3 step mediation tests were used to test the hypotheses after the correlation tests. Results - Results indicated that leader-member contact frequency and psychological distance have negative effects on job distress but positive effects on self-leadership. A mediation test revealed that self-leadership, in the relationships between contact frequency and job distress and between psychological distance and job distress, resulted in partial mediation and full mediation, respectively. Conclusions - The result can be understood through two different possible explanations. First, service area workers generally possess a positive perspective toward their leaders. This can be interpreted to mean that increased contact frequency and psychological distance would be considered as supports from the leader, rather than intrusive controls or management schemes. Therefore, the management in highway service areas should invest efforts in increasing contact frequency as well as maximizing psychological similarities by adopting the viewpoints of workers in terms of moral and ethical management, to reduce the workers' job distress. The results relating to self-leadership also indicate that increased contact frequency must be accompanied by intentions for the effective promotion of workers' self-leadership. It also signifies the necessity of a strategic approach by leaders to induce workers to perceive "in-group"ness as suggested both by the similarity-attraction theory and by the social identity theory. In addition, the results of the mediation test of self-leadership indicate that because workers' self-leadership activates upon increased contact frequency by the leader, it should not be a means of control and should not be utilized only from the perspective of management. It is also suggested that strategies such as transfer of authority could have a positive effect in promoting the expansion of self-influence from workers.