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

NCT05798221 | Completed

• 1 other identifier: 22-11002-BO
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

complementary medicine; COVID-19; post-COVID-19 Syndrome; randomized controlled trial; self-help

Outcome Measures

Primary Outcomes (1)

• Post-COVID-19 symptom burden

  Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden

  Week 16

Secondary Outcomes (18)

• Post-COVID-19 symptom burden

  Week 10

• Post-COVID-19 functional status (self-reported)

  Week 10

• Post-COVID-19 functional status (self-reported)

  Week 16

• Health-related quality of life

  Week 10

• Health-related quality of life

  Week 16

Other Outcomes (9)

• Treatment Expectation

  Week 0

• Self-efficacy

  Week 10

• Self-efficacy

  Week 16

Study Arms (2)

Complementary self-help strategies in addition to treatment as usual

EXPERIMENTAL

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.

Behavioral: Complementary self-help strategies in addition to treatment as usual

Treatment as usual

ACTIVE COMPARATOR

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.

Other: Treatment as usual

Interventions

Complementary self-help strategies in addition to treatment as usual 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

Complementary self-help strategies in addition to treatment as usual

Treatment as usual 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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

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

Essen, Germany

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustav Dobos, Prof. MD

  University of Duisburg-Essen

  STUDY CHAIR

• Heidemarie Haller, PhD

  University of Duisburg-Essen

  PRINCIPAL INVESTIGATOR

• Christoph Kleinschnitz, Prof. MD

  University of Duisburg-Essen

  STUDY DIRECTOR

• Mark Stettner, Prof. MD

  University of Duisburg-Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: April 4, 2023
• Study Start: April 25, 2023
• Primary Completion: March 25, 2025
• Study Completion: October 6, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)