Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome (NASH-POCO)

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidemarie Haller, PhD; Phone Number: +4920172377384; Email: heidemarie.haller@uk-essen.de
• Study Contact Backup: Name: Thi Thuy Nhi Cao; Phone Number: +4917647104822; Email: nhi.cao@uk-essen.de

Study Locations

• Germany
  • Essen, Germany
    • Recruiting
    • Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
    • Contact: Heidemarie Haller, PhD; Phone Number: +4920172377384; Email: heidemarie.haller@uk-essen.de
    • Contact: Thi Thuy Nhi Cao; Phone Number: +4917647104822; Email: nhi.cao@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Insomnia	Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia	Week 16
Insomnia	Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia	Week 10
Adverse events	All adverse events in relation and unrelated to the intervention	Weeks 0 - 10
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
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
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
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
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
Cardiovascular performance	6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity	Week 10
Cardiovascular performance	6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity	Week 16
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Expectation	Treatment Credibility Scale (TCS): expectation about the treatment effectiveness measured from 0 = no effectiveness to 10 = highest possible effectiveness	Week 0
Self-efficacy	Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy	Week 10
Self-efficacy	Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy	Week 16
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Study Chair: Gustav Dobos, Prof. MD, University of Duisburg-Essen; Principal Investigator: Heidemarie Haller, PhD, University of Duisburg-Essen; Study Director: Christoph Kleinschnitz, Prof. MD, University of Duisburg-Essen; Study Director: Mark Stettner, Prof. MD, University of Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; COVID-19; complementary medicine; self-help; post-COVID-19 Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: 22-11002-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No