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

Not Applicable

Active, not recruiting

• Conditions: Post-COVID-19 Syndrome
• Interventions: Other: Treatment as usual; Behavioral: Complementary self-help strategies in addition to treatment as usual

• Registration Number: NCT05798221
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-02
• Study First Posted: 2023-04-04
• Study Start: 2023-04-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Complementary self-help strategies in addition to treatment as usual	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.

Primary Outcome Measures

Name	Time	Method
Post-COVID-19 symptom burden	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 Outcome Measures

Name	Time	Method
Post-COVID-19 functional status (self-reported)	Week 16	Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Fatigue	Week 16	Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Post-COVID-19 symptom burden	Week 10	Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
Health-related quality of life	Week 16	Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Anxiety and depression	Week 16	Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher level of anxiety and depression
Insomnia	Week 10	Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Cardiovascular performance	Week 16	6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Pulmonary performance	Week 16	Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Post-COVID-19 functional status (physician-reported)	Week 16	Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Adverse events	Weeks 0 - 10	All adverse events in relation and unrelated to the intervention

Trial Locations

Locations (1)

Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen; 🇩🇪 Essen, Germany