Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder: A Pilot Study and Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Trail making test B (TMT-B)
研究概览
简要总结
The goal of this pilot Study and Randomized Controlled Trial is to investigate the impact of electroacupuncture on cognitive function, quality of life (QoL), and depression severity in patients with major depressive disorder (MDD).
The main question[s] it aims to answer are:
- Primary : electroacupuncture has the potential to treat subjective cognitive complaints and cognitive impairment in MDD outpatients
- Secondary : electroacupuncture has the potential to treat depressive in MDD outpatients The 60 participants will randomly be assigned to either the treatment group or the control group in a 1:1 ratio. The treatment group will undergo electroacupuncture (EA), while the control group will receive sham acupuncture within 10 weeks period.
Both groups will receive antidepressants with adjunctive medication (i.e., benzodiazepines, tricyclics, or antipsychotics) as the standard treatment. All participants will be assessed for executive functions and memory using specific cognitive tests, including the Trail Making Test B (TMT-B), Stroop Color and Word Test (SCWT), category delayed recall in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and subjective reports of concern regarding concentration, memory, problem-solving, learning, communication, and quality of life (QoL) concerns using the WHO Disability Assessment Schedule (WHODAS 2.0; sections D1.1-1.6 and H1-3), and depressive symptoms were assessed using the Thai-PHQ-9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In the sham acupuncture control group (CG), participants received acupress or a brief needle insertion at He gu on both hands during the first and 10th weeks, marking the endpoint of the study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 55 years
- •MDD diagnosed according to the DSM-5 or DSM-IV-TR criteria,
- •low suicidal risk
- •receiving treatment with antidepressants for at least 3 months from psychiatrists and psychiatric residents.
- •Subjective cognitive symptoms from the screening using the Thai version of the Patient Health Questionnaire (Thai-PHQ-9).
排除标准
- •severe cognitive deficits from traumatic brain injury, delirium, neurodevelopmental disorders, or intellectual disability;
- •neurological disorders such as stroke, Parkinson's disease, epilepsy, or other brain lesions;
- •severe medical conditions preventing lying down for 20 minutes;
- •recent electroconvulsive therapy (ECT) within the last 6 months;
- •Individuals with a pacemaker;
- •visual or hearing impairment that could not be corrected with eyeglasses or hearing aids;
- •severe MDD or scoring 20 points or more on the Thai-PHQ-9.
结局指标
主要结局
Trail making test B (TMT-B)
时间窗: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
The TMT- B is scored based on the time (in seconds) it takes to complete the test, including corrections for errors prompted by the examiner. A shorter time implies better performance.
The Stroop Color and Word Test (SCWT)
时间窗: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
SCWT used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute."Score" refers to the number of words achieved, and a higher number of words indicates a better score.
ADAS-cog category delayed recall
时间窗: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
ADAS-cog category delayed recall is used to assess memory. The score reflects the number of words that can be remembered. The more words remembered, the better the score.
Subjective cognitive complaint
时间窗: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
WHODAS 2.0; sections D1.1-1.6 and H1-3, which is a questionnaire asking about the number of days in the past 30 days when participants experienced difficulties with attention, understanding, and initiating conversation. "Score" is the rating of the number of days with issues, and a decrease in score indicates improvement or a better outcome.
次要结局
- Thai Patient Health Questionnaire (PHQ-9)(Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10))
研究者
Yindee Boontra
Doctor of Medicine
Thammasat University