Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome

NCT ID: NCT05798221

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2025-10-06

Brief Summary

Individuals affected by SARS-CoV-2 infection may subsequently be affected by the so-called post-COVID syndrome. The aim of the present study is to investigate the effects of a multimodal 10-week group program consisting of self-help strategies based on complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to treatment as usual versus treatment as usual alone (no active study intervention/waiting list). Endpoints of the study include subjective quantitative and qualitative as well as objective (physician-reported) variables.

Conditions

Post-COVID-19 Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Complementary self-help strategies in addition to treatment as usual

The experimental group consists of 10 weeks of group treatments with educative and actively practicing elements. The patients will also receive a booklet with self-help basics and descriptions of the techniques, which should facilitate the correct practice at home. Parallel treatment as usual is allowed.

Group Type: EXPERIMENTAL

Complementary self-help strategies in addition to treatment as usual

Intervention Type: BEHAVIORAL

The 10-week group program consists of self-help strategies from complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to treatment as usual

Treatment as usual

The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: OTHER

The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.

Interventions

Complementary self-help strategies in addition to treatment as usual

The 10-week group program consists of self-help strategies from complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to treatment as usual

Intervention Type: BEHAVIORAL

Treatment as usual

The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age of 18 years and older
• Confirmed COVID-19 diagnosis by: 1. polymerase chain reaction (PCR) test or 2. physician's letter/medical certificate/quarantine order due to ICD-10-GM U07.1 G or ICD-10-GM U09.9 G
• Sequelae symptoms, new symptoms/disabilities, or worsening of a pre-existing medical condition that occurred in the first 3 months after confirmed SARS-CoV-2 infection and persisted for more than 2 months
• At least 8 points (moderate symptom burden) out of a possible 32 points on the Somatic Symptom Scale-8 (SSS-8)

Exclusion Criteria

• Patients who were treated with invasive ventilation during active SARS-CoV-2 infection
• Severe comorbid mental illness (e.g. addiction diagnosis, major depression) or other severe comorbid somatic illness (e.g. cancer without remission, severe pre-existing cardiovascular disease, insufficiency of other organs such as kidney or liver, acute febrile infection, other severe neurologic disease)
• Pregnancy or lactation
• Current pension application
• Simultaneous participation in other clinical/interventional trials

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

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Heidemarie Haller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustav Dobos, Prof. MD

Role: STUDY_CHAIR

University of Duisburg-Essen

Heidemarie Haller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Duisburg-Essen

Christoph Kleinschnitz, Prof. MD

Role: STUDY_DIRECTOR

University of Duisburg-Essen

Mark Stettner, Prof. MD

Role: STUDY_DIRECTOR

University of Duisburg-Essen

Locations

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen

Essen, , Germany

Countries

Germany

Other Identifiers

22-11002-BO

Identifier Type: -

Identifier Source: org_study_id