Clinical trial NCT05798221: Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome
Official title: Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: complementary medicine
COVID-19
post-COVID-19 Syndrome
randomized controlled trial
self-help
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Post-COVID-19 symptom burden
timeFrame: Week 16
Secondary outcomes:
measure: Post-COVID-19 symptom burden
timeFrame: Week 10
measure: Post-COVID-19 functional status (self-reported)
timeFrame: Week 10
measure: Post-COVID-19 functional status (self-reported)
timeFrame: Week 16
measure: Health-related quality of life
timeFrame: Week 10
measure: Health-related quality of life
timeFrame: Week 16
measure: Fatigue
timeFrame: Week 10
measure: Fatigue
timeFrame: Week 16
measure: Anxiety and depression
timeFrame: Week 10
measure: Anxiety and depression
timeFrame: Week 16
measure: Insomnia
timeFrame: Week 16
measure: Insomnia
timeFrame: Week 10
measure: Cardiovascular performance
timeFrame: Week 10
measure: Cardiovascular performance
timeFrame: Week 16
measure: Pulmonary performance
timeFrame: Week 10
measure: Pulmonary performance
timeFrame: Week 16
measure: Post-COVID-19 functional status (physician-reported)
timeFrame: Week 10
measure: Post-COVID-19 functional status (physician-reported)
timeFrame: Week 16
measure: Adverse events
timeFrame: Weeks 0 - 10
Other outcomes:
measure: Treatment Expectation
timeFrame: Week 0
measure: Self-efficacy
timeFrame: Week 10
measure: Self-efficacy
timeFrame: Week 16
measure: Stress
timeFrame: Week 10
measure: Stress
timeFrame: Week 16
measure: Flourishing
timeFrame: Week 10
measure: Flourishing
timeFrame: Week 16
measure: Loneliness
timeFrame: Week 10
measure: Loneliness
timeFrame: Week 16
Locations:
city: Essen
country: Germany
facility: Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Study officials:
affiliation: University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_CHAIR
affiliation: University of Duisburg-Essen
name: Heidemarie Haller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Duisburg-Essen
name: Christoph Kleinschnitz, Prof. MD
role: STUDY_DIRECTOR
affiliation: University of Duisburg-Essen
name: Mark Stettner, Prof. MD
role: STUDY_DIRECTOR
References: