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

Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Post-COVID Syndrome
• Intervention / Treatment: Behavioral: Complementary and Integrative Medicine online intervention, routine care and book; Behavioral: Routine care and book

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Rösner; Phone Number: 004980505682; Email: naturheilkunde.studien@immanuel.de

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Recruiting
    • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
    • Principal Investigator: Andreas Michalsen, Prof. Dr.
    • Contact: Miriam Rösner, Study nurse; Phone Number: 00493080505682; Email: naturheilkunde.studien@immanuel.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complementary and Integrative Medicine online intervention, routine care and book	Behavioral: 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).
Active Comparator: Routine care and book	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36 (SF-36), Physical Functioning Scale	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectation regarding study intervention	5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.	Baseline
Satisfaction with the intervention	5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.	Week 10
Adherence to the study intervention	Asking Minutes (min.) of the last week	Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Short Form 36 (SF-36)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Post-COVID-Syndrom (PCS) Score	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Chalder Fatigue Scale (CFS)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Quality of life (EQ-5D-5L)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
General Self-Efficacy Scale (GSE, German version: ASKU)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) physical strength	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) mental strength	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) headache	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Patient Health Questionnaire 9 (PHQ9)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Pittsburgh Sleep Quality Index (PSQI)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)		Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Perceived Stress Scale (PSS 4)	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Safety by recording adverse events		Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)		Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50
Continuation of the intervention	Asking Minutes (min.) of the last month	10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative data	After the end of the intervention, qualitative data will be collected at week 10 from a randomized subpopulation (n=15-20) for the purpose of evaluating the online intervention from the patient's perspective using semi-structured, guided interviews with narrative components (of interest, for example, are the subjective experiences, the experience of the disease and its effects).	Week 10
Sub-study: Focus group interviews with physicians	In a sub-study, focus group interviews will be conducted with n=7-10 primary care physicians in routine care. Depending on the research results, the number and structure of the interviews and the interviewed patients can be adapted according to the explorative requirements of the qualitative analysis. The interviews will be digitally recorded, pseudonymously transcribed and qualitatively analyzed.	Week 10
Sub-study: biosignal characteristics	In another subgroup (electrophysiological sub-study) with n=48 participants, multichannel electrophysiological measurements are performed in each case at baseline and week 10, in which heart rate, blood pressure, respiratory rate, pulse, electrodermal activity and brain activity (EEG) are recorded synchronously - by means of monitoring systems (SOMNOmedics, SOMNO HD EEG 32) and Corsano Smartwatch. Furthermore, hand force is measured in a standardized way.	Baseline, week 10

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: NHKOnline

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No