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Clinical Trials/NCT05798221
NCT05798221CompletedNot Applicable

Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial

Universität Duisburg-Essen1 site in 1 country86 target enrollmentStarted: April 25, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
86
Locations
1
Primary Endpoint
Post-COVID-19 symptom burden
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age of 18 years and older
  • •Confirmed COVID-19 diagnosis by:
  • •polymerase chain reaction (PCR) test or
  • •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

Outcomes

Primary Outcomes

Post-COVID-19 symptom burden

Time Frame: Week 16

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

Secondary Outcomes

  • Post-COVID-19 functional status (self-reported)(Week 16)
  • Fatigue(Week 16)
  • Post-COVID-19 symptom burden(Week 10)
  • Health-related quality of life(Week 16)
  • Anxiety and depression(Week 16)
  • Insomnia(Week 10)
  • Cardiovascular performance(Week 16)
  • Pulmonary performance(Week 16)
  • Post-COVID-19 functional status (physician-reported)(Week 16)
  • Adverse events(Weeks 0 - 10)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heidemarie Haller

Principal Investigator

Universität Duisburg-Essen

Study Sites (1)

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