Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19

Charité University Medicine Berlin

Status: Enrolling

Conditions: Post-COVID Syndrome

Treatments: Behavioral: Routine care and book; Behavioral: Complementary and Integrative Medicine online intervention, routine care and book

Study type: Interventional

Funder types: Other

Identifiers

NCT06004362

NHKOnline

Details and patient eligibility

About

The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or SARS-CoV-2 antibodies)
• History of chronic fatigue (after SARS-CoV-2 infection)
• At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia
• Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points ("What is your physical exercise capacity on average over the last 7 days?")
• Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points
• Patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home

Exclusion criteria

• Fatigue already present before SARS-CoV-2 infection
• Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7 OR 8 with yes AND >14h condition worsening)
• Other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse
• Other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • Ongoing opioid therapy or opioid therapy in the week prior to study entry
• Regular use of cannabinoids or other illicit drugs in the month prior to or during the study
• Restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry
• Pregnancy or breastfeeding
• Participation in another clinical intervention study during study participation 1
• Regular use of Complementary and Integrative Medicine self-help measures (e.g. meditation, Kneipp hydrotherapiy, etc.) within the study period
• Current pension procedure or planned claiming of a pension procedure due to disability
• Planned rehabilitation measures during study participation due to post-COVID syndrome

Inclusion and exclusion criteria of the sub-study focus group interviews with physicians

Inclusion criteria:

• Family physicians and general practitioners
• Regular outpatient care of patients with post-covid syndrome
• Willingness in principle to participate in a 2-hour interview on-site or online

Exclusion criteria:

• No previous care of post-covid patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Complementary and Integrative Medicine online intervention, routine care and book

Experimental group

Treatment:

Behavioral: Complementary and Integrative Medicine online intervention, routine care and book

Routine care and book

Active Comparator group

Treatment:

Behavioral: Routine care and book