Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06633666

Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

acupuncture

Device
  • Fatigue Principal points: Pishu (BL 20), Ganshu (BL 18), Shenshu (BL 23), Baihui (GV 20), Guanyuan (RN 4), Zusanli (ST 36), Sanyinjiao (SP 6)
  • Anxiety/ depression Principal points: Yintang (EX-HN3), Baihui (GV 20), Taichong (LR 3), Neiguan (PC 6), Danzhong (RN 7)
  • Cognitive impairment/ memory loss Principal points: Baihui (GV 20), Sishencong (EX-HN1), Fengfu (GV 16), Taixi (K 13), Xuanzhong (GB 39), Zusanli (ST 36)
  • Insomnia Principal points: Zhaohai (K 16), Shenmai (BL 62), Shenmen (HT 7), Sanyinjiao (SP 6), Anmian (EX-HN22), Sishencong (EX-HN1)

Primary outcomes

  1. Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale

    Time frame: 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 outcomes

  1. Depression on the Chinese Beck Depression Inventory (CBDI)

    Time frame: 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.

  2. Score of Insomnia Severity Index (ISI)

    Time frame: 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.

  3. Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form

    Time frame: 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).

  4. Hamilton Depression Scale (HAMD)

    Time frame: 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.

  5. Hamilton Anxiety Rating Scale (HAMA)

    Time frame: 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.

  6. Traditional Chinese Medicine Symptom Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Zhong, MD., Ph.D

CONTACT

[email protected]

85234116523

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Official study title

Acupuncture for Long COVID Neuropsychiatric Symptoms: a Pragmatic,Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.