研究疾病:
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疲勞性亞健康
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研究疾病代码:
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Target disease:
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Fatigue-predominant Subhealth
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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這項研究主要目的是探討以正念減壓療法為基礎的正念訓練干預對疲勞性亞健康人群的有效性,與對照組相比,觀察干預前後之疲勞水平和生活質量方面的變化,其次為探討情緒與疲勞性亞健康的關係。
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Objectives of Study:
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The primary aim of this research is to examine the effectiveness of a mindfulness-based intervention towards the fatigue-predominant subhealth population. It is hypothesized that mindfulness training show effectiveness in the level of fatigue and quality of life compared to the control group. The secondary aim of this research is to examine the relationship between mental state and fatigue-predominant subhealth population.
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药物成份或治疗方案详述:
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參考MBSR認證導師所撰寫之有關正念訓練的書籍及文獻,考慮可行性後,設計正念訓練四週課程。以下為教學方式舉隅:
A. 幻燈片簡報視頻:在干預開始前說明正念是什麼和不是什麼,介紹訓練結構,讓參與者知道未來在團體中大家會如何互動 自行判斷自己是否適合此干預。簡單介紹RAIN 和 STOP技巧。
B. 音頻引導:正念訓練的主要部分需要有聲音帶領進行,由研究者參考由MBSR認證導師過往的音訊或其書中所節錄的講稿親自錄製,剪輯後加上字幕後上載於Youtube私人頻道,給予實驗組連結作正式練習使用:正念呼吸、身體掃描、念頭想法覺察、坐禪、慈心禪。
C. 視頻引導:正念訓練的正念瑜伽或坐襌部分需要有聲音帶領進行,由研究者參考由MBSR認證導師過往的視訊或其書中所節錄的講稿親自錄製,剪輯後加上字幕後上載於Youtube私人頻道,給予實驗組連結作正式練習使用:立式瑜伽。
D. 練習冊:由研究者節選出教學重點的文字版及正念瑜伽圖片版,供個案自行練習時參考。小冊子附有訓練紀錄表以供研究者跟進其完成度,紀錄表將設網上版及可列印版。
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Description for medicine or protocol of treatment in detail:
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Participants in the active-treatment group would follow an online mindfulness practice routine that the researcher created based on the standard MBSR course outline. The scripts of recordings or videos in provided materials are excerpted from MBSR guiding books written by certified MBSR instructors.
Refer to the books on mindfulness training written by MBSR certified instructors, and after considering the feasibility, the researcher designed a four-week mindfulness training course. The following are details of teaching methods:
A. Slide presentation video
Before the intervention, a recorded online zoom lecture would be held to explain what concept of mindfulness, to introduce the training structure so as to inform participants how they will interact in groups in the future and judge whether they are suitable for this intervention. A brief introduction to RAIN and STOP techniques in the third week would be performed in this format as well.
B. Audio guidance
The main part of mindfulness training needs to be guided by voice. The researcher will personally record it by referring to the past audio of the MBSR certified instructor or the excerpted scripts from guide books. After editing, adding subtitles, recoding would be uploaded to the Youtube private channel. The experimental group would be given the links for formal exercises: 15 minutes of mindful breathing, 15 minutes of body scanning, 15 minutes of mindfulness-awareness training, 15 minutes of self-inquiry practice, and 15 minutes of Ci Xin meditation.
C. Video guidance
The mindfulness yoga or sitting meditation of mindfulness training needs to be guided by video format, other details are the same as audio guidance. This is for 15-minute walking meditation.
D. Workbook
The text version of the teaching key points, and the picture version of mindfulness yoga are selected by the researcher for reference during self-practice. The booklet consists of training record sheets for researchers to follow up on their completion. The record sheet will be available in an online version and a printable version.
E. Sharing sessions through social media groups
Sharing thoughts and feelings during mindfulness practices is an important session in the MBSR teaching structure. Due to social distancing measures under the COVID-19 pandemic, the sharing sessions would be changed into texting format (i.e. Dividing experimental groups into smaller groups randomly and creating Whatsapp groups for small group sharing).
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纳入标准:
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1. 18-60歲以疲勞為主訴,持續或反復出現三個月或以上人士,經疲勞自評量表FSAS測試後結果於中度及嚴重疲勞範圍;
2. 具有亞健康狀態的臨床表現,包括:
①以疲勞,或睡眠紊亂,或疼痛等軀體症狀表現為主;
②以抑鬱寡歡,或焦躁不安、急躁易怒,或恐懼膽怯,或短期記憶力下降、注意力不能集中等精神心理症狀表現為主;
③以人際交往頻率減低,或人際關係緊張等社會適應能力下降表現為主。
上述 3 條中的任何一條持續發作 3 個月以上,並且自稱已排除可能導致上述表現的疾病者,目前可分别被判斷為處於軀體亞健康、心理亞健康、社會交往亞健康狀態。臨床上,上述三種亞健康表現常常相兼出現。
3.《亞健康評定量表》(SHMS V1.0)中三個子量表任何一個量表分數低於劃線分數,即生理亞健康分量表<68 分,心理亞健康分量表<67 分,同時社會亞健康分量表<67 分;
4. 能自主行動、心理狀態能夠配合研究。
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Inclusion criteria
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1. Aged within the range of 18 to 60 years;
2. With continuous or repeated moderate-to-severe fatigue symptoms for three months or more, the result of FSAS is with the range of moderate to severe;
3. Have clinical manifestations of sub-health state, including:
(1) Mainly manifested by physical symptoms such as fatigue, sleep disturbance, or pain;
(2) Mainly manifested by mental and psychological symptoms such as depression, restlessness, irritability, or fear and timidity, or short-term memory loss, and inability to concentrate;
(3) Mainly manifested by the decline of social adaptability, for instance, a decrease in the frequency of interpersonal communication.
Any one of the above 3 items has been onset for more than 3 months, and those who claim to have ruled out the diseases that may cause the above-mentioned manifestations can be judged as being in physical sub-health, mental sub-health, and social sub-health respectively. Clinically, the above three sub-health manifestations often appear at the same time.
4. The score of any one of the three sub-scales in the "Sub-health Assessment Scale" (SHMS V1.0) is lower than the underlined score, that is, the physiological sub-health subscale <68 points, the mental sub-health subscale <67 points, and the social sub-health subscale < 67 points.
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排除标准:
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1. 無法於網上瀏覽影片人士;
2. 在過去半年內具正念訓練習慣者;
3. 有嚴重精神疾患者;
4. 患有嚴重器質性疾病患者;
5. 屬急性疲勞者;
6. 不具中文讀寫能力。
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Exclusion criteria:
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1. Has practiced mindfulness training in the past 6 months;
2. With acute fatigue symptoms (i.e., symptoms last less than 3 months);
3. Cognitively or emotionally impaired;
4. Unable to use electronic devices and access to internet (since participants are required to browse teaching videos online);
5. Inability to speak or write;
6. Have severe physiological impairment.
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研究实施时间:
Study execute time:
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从From
2021-05-01
至To
2022-02-01
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征募观察对象时间:
Recruiting time:
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从From
2021-05-01
至To
2021-09-01
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