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

Sponsor

Universität Duisburg-Essen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05798221

Collaborator

(none)

Enrollment

Arms

32.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-COVID-19 Syndrome	Behavioral: Complementary self-help strategies in addition to treatment as usual Other: Treatment as usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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
Post-COVID-19 functional status (self-reported) [Week 10]
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
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
Health-related quality of life [Week 10]
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
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
Fatigue [Week 10]
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
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
Anxiety and depression [Week 10]
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher levels of anxiety and depression
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 16]
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Insomnia [Week 10]
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Cardiovascular/pulmonary performance [Week 10]
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Cardiovascular/pulmonary performance [Week 16]
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Post-COVID-19 functional status (physician-reported) [Week 10]
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
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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