Online complementary and integrative medicine for post-COVID syndrome
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.
NA · Charite University, Berlin, Germany · NCT06004362
This study is testing whether an online program using complementary medicine can help people with post-COVID syndrome feel better by reducing symptoms like fatigue and sleep issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06004362 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an online intervention using complementary and integrative medicine for patients suffering from post-COVID syndrome, a condition that can arise after COVID-19 infection. It is a prospective, two-arm, randomized-controlled intervention that includes both qualitative and physiological sub-studies, employing a mixed-methods design. Participants will receive routine care alongside the online intervention, aiming to alleviate symptoms such as chronic fatigue, sleep disturbances, and cognitive impairments.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had an acute SARS-CoV-2 infection at least 12 weeks prior and are experiencing chronic fatigue along with multiple other symptoms.
Not a fit: Patients who had fatigue prior to their SARS-CoV-2 infection or those with severe post-exertional malaise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from post-COVID syndrome.
How similar studies have performed: While there is ongoing research into post-COVID interventions, this specific approach using online complementary and integrative medicine is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
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
Where this trial is running
Berlin
- Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus — Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Miriam Rösner
- Email: naturheilkunde.studien@immanuel.de
- Phone: 004980505682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-COVID Syndrome