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

Post-COVID-19 Syndrome Clinical Trial

— NASH-POCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798221
• Other study ID #: 22-11002-BO
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Universität Duisburg-Essen
• Contact: Heidemarie Haller, PhD
• Phone: +4920172377384
• Email: heidemarie.haller[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome
• Syndrome

Intervention

Behavioral:
• 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

Other:
• 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.

Locations

Country	Name	City	State
Germany	Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Expectation	Treatment Credibility Scale (TCS): expectation about the treatment effectiveness measured from 0 = no effectiveness to 10 = highest possible effectiveness	Week 0
Other	Self-efficacy	Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy	Week 10
Other	Self-efficacy	Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy	Week 16
Other	Stress	Perceived Stress Scale (PSS): 10-item scale, summed to create a psychological stress score of maximal 40 points with higher scores indicating greater psychological stress	Week 10
Other	Stress	Perceived Stress Scale (PSS): 10-item scale, summed to create a psychological stress score of maximal 40 points with higher scores indicating greater psychological stress	Week 16
Other	Flourishing	Flourishing-Scale (FS): the scale ranges from 8 (lowest possible value) to 56 (highest possible value) with higher values correspond to a person with many psychological resources and strengths	Week 10
Other	Flourishing	Flourishing-Scale (FS): the scale ranges from 8 (lowest possible value) to 56 (highest possible value) with higher values correspond to a person with many psychological resources and strengths	Week 16
Other	Loneliness	UCLA Loneliness Scale (UCLA-LS): the short form of the UCLA-LS constsis of 12 items, ranges from 0 to 36 points, with higher higher scores indicating greater loneliness	Week 10
Other	Loneliness	UCLA Loneliness Scale (UCLA-LS): the short form of the UCLA-LS constsis of 12 items, ranges from 0 to 36 points, with higher higher scores indicating greater loneliness	Week 16
Primary	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	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 10
Secondary	Post-COVID-19 functional status (self-reported)	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	Week 10
Secondary	Post-COVID-19 functional status (self-reported)	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	Week 16
Secondary	Health-related quality of life	Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state	Week 10
Secondary	Health-related quality of life	Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state	Week 16
Secondary	Fatigue	Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue	Week 10
Secondary	Fatigue	Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue	Week 16
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher levels of anxiety and depression	Week 10
Secondary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher level of anxiety and depression	Week 16
Secondary	Insomnia	Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia	Week 16
Secondary	Insomnia	Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia	Week 10
Secondary	Cardiovascular performance	6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity	Week 10
Secondary	Cardiovascular performance	6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity	Week 16
Secondary	Pulmonary performance	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	Week 10
Secondary	Pulmonary performance	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	Week 16
Secondary	Post-COVID-19 functional status (physician-reported)	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	Week 10
Secondary	Post-COVID-19 functional status (physician-reported)	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	Week 16
Secondary	Adverse events	All adverse events in relation and unrelated to the intervention	Weeks 0 - 10