Clinical trial NCT06633666: Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms
Official title: Acupuncture for Long COVID Neuropsychiatric Symptoms: a Pragmatic,Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid19
Neuropsychiatric Symptom
Acupuncture
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
Secondary outcomes:
measure: Depression on the Chinese Beck Depression Inventory (CBDI)
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
measure: Score of Insomnia Severity Index (ISI)
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
measure: Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
measure: Hamilton Depression Scale (HAMD)
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
measure: Hamilton Anxiety Rating Scale (HAMA)
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
measure: Traditional Chinese Medicine Symptom Scale
timeFrame: At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Hong Kong Baptist University
name: Dong Jue Wei, MD.
role: STUDY_CHAIR
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