Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms
- Conditions
- Long Covid19Neuropsychiatric SymptomAcupuncture
- Interventions
- Device: Acupuncture
- Registration Number
- NCT06633666
- Lead Sponsor
- Hong Kong Baptist University
- Brief Summary
In this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long Covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.
- Detailed Description
This is a pragmatic, randomized, double-blinded clinical trial on acupuncture for treating neuropsychiatric symptoms in long Covid patients. A total of 160 participants will be diagnosed by a registered Chinese medicine practitioner and randomly assigned to the acupuncture and the control group with a 1:1 ratio. The acupuncture group will receive 24 sessions of interventions during a 12-week treatment duration (2 sessions per week) and will be followed up at week 18. The control group will only receive conventional therapy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- meet the clinical diagnosis of Long COVID by the World Health Organization (WHO), with no neuropsychiatric symptoms 1 year before infection with Covid-19, and continue to have at least one neuropsychiatric symptom for 2 months after SARS-CoV-2 turned negative 3 months above;
- aged 12 to 80 years;
- willing and able to consent, and complete all assessment and study procedures
- patients with a history of chronic neuropsychiatric symptoms;
- cardiovascular diseases pre-existing to the Covid-19 episode such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
- documented pre-existing history of psychiatric illness, including substance abuse;
- suicidal tendencies (attempted suicide in the 12 months before the study);
- any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
- those who participated in other clinical trials within one month;
- pregnant or lactating female patients;
- have surgery within two months before the study or will have a scheduled surgery during the study;
- acute brain injury or acute encephalopathy from another etiology than Covid-19 (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
- open-heart cardiac surgery or cardiac arrest during the last 6 months;
- patients who received acupuncture treatment 1 month before the start of the study;
- patients who were unable to complete the assessment during screening due to severe mental, cognitive, or emotional impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture Acupuncture The acupuncture intervention will be conducted for 2 sessions per week during a 12-week treatment duration and will be followed up at week 18. This research is based on the TCM theory of individualized acupuncture. Qualified participants will first conduct TCM syndrome differentiation according to the five main manifestations of Long COVID neuropsychiatric symptoms including fatigue, anxiety/depression, cognitive impairment, memory loss, and insomnia. They will be divided into four treatment groups according to their main clinical symptoms, and the participants in the treatment group will be treated with the selected acupoints according to their disease category. The selection of the acupoints for each syndrome type are formulated with reference to the 13th Five-Year Plan Textbook "Acupuncture and Moxibustion Therapy" published by the China Press of Traditional Chinese Medicine Co.,Ltd.
- Primary Outcome Measures
Name Time Method Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.
- Secondary Outcome Measures
Name Time Method Depression on the Chinese Beck Depression Inventory (CBDI) At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.
Score of Insomnia Severity Index (ISI) At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.
Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
Hamilton Depression Scale (HAMD) At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) A validated 24-item scale used to assess depressive severity across emotional, cognitive, and somatic domains. Scores range as follows: 0-7 (normal), 8-17 (mild depression), 18-24 (moderate depression), and ≥25 (severe depression), with higher scores indicating more severe depressive symptoms.
Hamilton Anxiety Rating Scale (HAMA) At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) A 14-item scale for assessing anxiety symptoms across somatic and psychological domains. Scoring ranges are: 0-7 (normal), 8-14 (mild anxiety), 15-28 (moderate anxiety), and ≥29 (severe anxiety), with higher scores indicating greater anxiety severity.
Traditional Chinese Medicine Symptom Scale At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up) A TCM-specific symptom scale following "Guidelines for Clinical Research on New Chinese Medicine," assessing syndrome severity based on TCM diagnostics. Scores quantify symptom burden with defined thresholds for mild, moderate, and severe syndrome levels, enabling standardized assessment of TCM syndrome differentiation.
Trial Locations
- Locations (1)
Linda Zhong
🇭🇰Kowloon Tong, Kowloon, Hong Kong