Electrical acupoint stimulation for psychiatric sequelae in women victims of domestic violence: study protocol for an assessor-blind randomized controlled trial.
IF 3.4 2区 医学Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Sichang Yang, Agnes Tiwari, Denise Shuk Ting Cheung, Calvin Pak Wing Cheng, Mei Yan Chan, Haiyong Chen, Zhang-Jin Zhang
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引用次数: 0
Abstract
Background: Domestic violence is a global public health problem linked to mental illness morbidity. A significant proportion of domestic violence victims have been found to exhibit unsatisfactory response rates to first-line treatments and display low acceptance levels towards psychological interventions. To improve the therapeutic effectiveness for this population, we aim to develop an electrical acupoint stimulation modality that integrates clinic-based and home-based therapies, with the goal of improving the psychiatric symptoms experienced by women victims of domestic violence.
Methods: This is an assessor-blinded randomized controlled trial, consisting of 110 women victims diagnosed with depression. The patients will be randomly assigned to either the treatment group or the routine care group in a 1:1 ratio. The treatment group will receive electrical acupoint stimulation over a period of 12 consecutive weeks, in addition to their routine care. On the other hand, the routine care group will not receive any electrical acupoint stimulation until the end of the 12-week study. The primary outcome of the study is the mean change in the score of Beck Depression Inventory-II (BDI-II) from baseline to the end of the 12-week treatment. Secondary outcomes will include the 17-item Hamilton Depression Rating Scale (HAMD-17), 10-Item Perceived Stress Scale (PSS-10), PTSD Check List-Civilian Version (PCL-C), Insomnia Severity Index (ISI), 12-Item Short Form Survey (SF-12), as well as any observed adverse events.
Discussion: If effective, this electrical acupoint stimulation modality could have significant clinical and research implications for women victims of domestic violence with psychiatric sequelae.
Trials registration: ClinicalTrials.gov as NCT05102253. Registered 1 November 2021. https://www.
背景:家庭暴力是一个与精神疾病发病率有关的全球性公共卫生问题。相当大比例的家庭暴力受害者对一线治疗的反应率令人不满意,对心理干预的接受程度也很低。为了提高对这一人群的治疗效果,我们的目标是开发一种结合临床和家庭治疗的穴位电刺激方式,目的是改善家庭暴力妇女受害者的精神症状。方法:这是一项评估盲随机对照试验,由110名诊断为抑郁症的女性受害者组成。患者将按1:1的比例随机分配到治疗组或常规护理组。治疗组在常规护理的基础上,连续12周接受穴位电刺激。另一方面,常规护理组在12周的研究结束前不会接受任何穴位电刺激。该研究的主要结果是贝克抑郁量表- ii (BDI-II)评分从基线到12周治疗结束时的平均变化。次要结果将包括17项汉密尔顿抑郁评定量表(HAMD-17)、10项感知压力量表(PSS-10)、创伤后应激障碍检查表-平民版(PCL-C)、失眠严重程度指数(ISI)、12项简短问卷调查(SF-12)以及观察到的任何不良事件。讨论:如果有效,这种穴位电刺激方式可能对有精神后遗症的家庭暴力女性受害者具有重要的临床和研究意义。试验注册:ClinicalTrials.gov,编号NCT05102253。注册于2021年11月1日。https://www.Clinicaltrials: gov/study/NCT05102253。