Chandelier
Senior Member (Voting Rights)
ClinicalTrials.gov
Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome (NASH-POCO)
ClinicalTrials.gov ID: NCT05798221
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.
Study Start (Actual)
2023-04-25
Primary Completion (Actual)
2025-03-25
Study Completion (Actual)
2025-10-06
Enrollment (Actual)
86
How is the study designed? Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : Double (InvestigatorOutcomes Assessor)
Arms and Interventions
Participant Group/Arm 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.Intervention/Treatment 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
Participant Group/Arm 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.Intervention/Treatment 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
Secondary Outcome Measures
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
Other Outcome Measures
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 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 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 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 Adverse events All adverse events in relation and unrelated to the intervention Weeks 0 - 10
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