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

NCT ID: NCT06004362

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Post-COVID Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Complementary and Integrative Medicine online intervention, routine care and book

Group Type: EXPERIMENTAL

Complementary and Integrative Medicine online intervention, routine care and book

Intervention Type: BEHAVIORAL

The online program takes place in a multiprofessionally guided online group setting once a week for up to 180 minutes (including several breaks) over a period of 10 weeks:

• Basic principles of a plant-based whole-food nutrition
• Procedures of hydrotherapy according to Kneipp
• Self-help strategies (e.g. teas, wraps, compresses etc.)
• Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.)
• Methods of extended Complementary and Integrative Medicine (e.g. acupressure)

It is recommended to practice a part of the taught exercises at home for about 30 minutes daily. In addition, the patients receive a book for the treatment of post-covid syndrome complaints. Group 1 additionally uses the already existing routine care (e.g. general practitioner).

Routine care and book

Group Type: ACTIVE_COMPARATOR

Routine care and book

Intervention Type: BEHAVIORAL

Participants in the second study arm receive routine care, e.g. from their general practitioner. In addition, the patients receive the same book as group 1 for the treatment of post-covid syndrome complaints. The participants of the second study arm will be offered to participate in the Complementary and Integrative Medicine online intervention after 4 months within the study.

Interventions

Complementary and Integrative Medicine online intervention, routine care and book

The online program takes place in a multiprofessionally guided online group setting once a week for up to 180 minutes (including several breaks) over a period of 10 weeks:

• Basic principles of a plant-based whole-food nutrition
• Procedures of hydrotherapy according to Kneipp
• Self-help strategies (e.g. teas, wraps, compresses etc.)
• Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.)
• Methods of extended Complementary and Integrative Medicine (e.g. acupressure)

It is recommended to practice a part of the taught exercises at home for about 30 minutes daily. In addition, the patients receive a book for the treatment of post-covid syndrome complaints. Group 1 additionally uses the already existing routine care (e.g. general practitioner).

Intervention Type: BEHAVIORAL

Routine care and book

Participants in the second study arm receive routine care, e.g. from their general practitioner. In addition, the patients receive the same book as group 1 for the treatment of post-covid syndrome complaints. The participants of the second study arm will be offered to participate in the Complementary and Integrative Medicine online intervention after 4 months within the study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• 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

• No previous care of post-covid patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Andreas Michalsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Miriam Rösner

Role: CONTACT

naturheilkunde.studien@immanuel.de

004980505682

Facility Contacts

Miriam Rösner, Study nurse

Role: primary

naturheilkunde.studien@immanuel.de

00493080505682

Other Identifiers

NHKOnline

Identifier Type: -

Identifier Source: org_study_id