研究疾病:
|
轻度抑郁障碍发作
|
研究疾病代码:
|
|
Target disease:
|
Mild depressive episode
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
探索性研究/预试验
Pilot clinical trial
|
研究目的:
|
采用随机对照试验,将轻度抑郁障碍人群随机分为针刺组与安慰针组,采用疏肝调神针法治疗1周,自治疗前1周采集情绪动力信息,并在第1次治疗前、第1次治疗后、治疗1周后采集情绪注意偏向与额叶脑网络拓扑属性的特征,通过组间对比探索疏肝调神针法对额叶相关脑网络的即刻效应与累及效应,基于情绪动力—额叶相关脑网络耦合病理模型阐释疏肝调神针法抗抑郁快速起效的情绪心理-中枢额叶相关脑网络效应机制。
|
Objectives of Study:
|
Randomized controlled trial was used to randomly divide the population with mild depressive disorder into acupuncture group and comfort acupuncture group. The acupuncture method of soothing the liver and regulating the mind was used to treat them for one week. The emotional and dynamic information was collected one week before the treatment, and the characteristics of emotional attention bias and frontal lobe brain network topology attributes were collected before, after and after the first treatment. The immediate effect and involvement effect of the acupuncture method of soothing the liver and regulating the mind on frontal lobe related brain networks were explored through comparison between groups, Based on the emotional dynamics frontal lobe related brain network coupling pathological model, this paper explains the emotional psychology central frontal lobe related brain network effect mechanism of the anti depression effect of soothing the liver and regulating the mind acupuncture method.
|
药物成份或治疗方案详述:
|
1.针刺组
采用针刺治疗抑郁障碍临床成熟有效的“疏肝调神”针刺方案,以期最大化实现针刺抗抑郁效果。
(1)针刺:百会、印堂、头维、鸠尾、中脘、气海、太冲(双)、合谷(双)、三阴交(双)。定穴消毒后,选取0.22×40mm或0.25×25mm一次性针灸针,套叠式针管进针,得气后嘱患者用鼻深呼吸,留针30分钟。
(2)皮内针:神堂、魂门与心俞、肝俞交替使用。例如第一次选用心俞、肝俞,则第二次选用神堂、魂门。定穴消毒后,镊子持0.20×0.6mm无菌揿针置于穴位粘贴固定,留置3天。
诸穴位定位参照中华人民共和国国家标准《腧穴名称与定位》(GB/T 12346-2006)。针刺组受试者每周治疗3次,连续治疗1周。
2.安慰针组
针刺、耳针取穴与针刺组相同。所用针灸针为安慰针,针尖为钝头,采用套叠式针管进针,针尖未刺入皮肤,以实现针刺的安慰对照。所用揿针均为安慰揿针,外观与无菌揿针相同,但其中央无短针,以实现耳针的安慰对照。安慰针组受试者每周治疗3次,连续治疗1周。
3.合并用药要求
研究二受试者不服用任何抗抑郁药物。
|
Description for medicine or protocol of treatment in detail:
|
1. Acupuncture group
The clinically mature and effective acupuncture program of "soothing the liver and regulating the mind" was adopted for the treatment of depressive disorder, in order to maximize the effect of acupuncture on depression.
(1) Acupuncture: Baihui, Yintang, Touwei, Jiuwei, Zhongwan, Qihai, Taichong (Shuang), Hegu (Shuang), Sanyinjiao (Shuang). Select 0.22 after point disinfection × 40mm or 0.25 × A 25mm disposable acupuncture needle is inserted into the needle with a nested needle tube. After getting qi, the patient is instructed to breathe deeply through the nose and the needle is retained for 30 minutes.
(2) Intradermal needles: Shentang, Hunmen, Xinyu and Ganshu are used alternately. For example, if Xinyu and Ganyu are selected for the first time, Shentang and Soul Gate will be selected for the second time. After point disinfection, hold 0.20 with forceps × The 0.6 mm sterile press needle was placed at the acupoint for pasting and fixation, and was retained for 3 days.
The positioning of all acupoints shall refer to the national standard of the People's Republic of China, "Names and Positioning of Acupoints" (GB/T 12346-2006). The subjects in the acupuncture group were treated 3 times a week for 1 week.
2. Comfort needle group
Acupuncture and auricular acupuncture were the same as those in the acupuncture group. The acupuncture needle used is a comfort needle with blunt tip. The needle is inserted with a jacketed needle tube, and the needle tip does not penetrate the skin, so as to achieve the comfort control of acupuncture. All the press needles used are comfort press needles, which have the same appearance as sterile press needles, but no short needle in the center to achieve comfort control of ear acupuncture. The subjects in the comfort needle group were treated 3 times a week for 1 week.
3. Requirements for combined drug use
Study 2 subjects did not take any antidepressant drugs.
|
纳入标准:
|
(1)首发抑郁发作,未经过系统规范的治疗,符合ICD-10轻度抑郁发作诊断标准者;
(2)8分≤HAMD (Hamilton Depression Scale)-17≤17分;
(3)年龄为18~55岁;
(4)右利手;
(5)能理解并完成本研究的观察指标内容,同意签署知情同意书者。
|
Inclusion criteria
|
(1) The first depressive episode, without systematic and standardized treatment, meets the ICD-10 diagnostic criteria for mild depressive episode;
(2) 8 points ≤ HAMD (Hamilton Compression Scale) - 17 points ≤ 17 points;
(3) The age ranged from 18 to 55 years;
(4) Right handed;
(5) Those who can understand and complete the contents of the observation indicators of this study and agree to sign the informed consent form.
|
排除标准:
|
(1)器质性精神障碍,或与精神活性物质和非成瘾物质相关的抑郁;
(2)有家族其他精神病史如:痴呆、精神分裂、躁狂、瘾症等;
(3)有妊娠、备孕或哺乳期;
(4)合并有皮损或皮肤病患者、严重糖尿病、肿瘤或严重心血管、肺、肝、肾和造血系统等内科疾病者;
(5)有自伤行为、自杀倾向及自杀未遂历史者
(6)生活作息昼夜颠倒或不规律,无法完成本研究的日常情绪测量。
|
Exclusion criteria:
|
(1) Organic mental disorder, or depression related to psychoactive substances and non addictive substances;
(2) Have other family psychiatric history, such as dementia, schizophrenia, mania, addiction, etc;
(3) Pregnancy, preparation for pregnancy or lactation;
(4) Patients with skin lesions or skin diseases, severe diabetes, tumors or serious cardiovascular, lung, liver, kidney, hematopoietic system and other medical diseases;
(5) Those who have a history of self injuring behavior, suicidal tendency and attempted suicide
(6) The daily mood measurement of this study could not be completed due to the reversal or irregularity of daily work and rest.
|
研究实施时间:
Study execute time:
|
从From
2022-12-01
至To
2024-07-31
|
征募观察对象时间:
Recruiting time:
|
从From
2022-12-01
至To
2024-07-31
|