Last updated: July 13, 2023
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hypochondriasis
Somatoform And Dissociative Disorders
Functional Dyspepsia
Treatment
social contact
yoga
Clinical Study ID
NCT05946512
1034/2023
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Inclusion criteria for participants with Post COVID condition
- Eligible patients will be recruited at the Respiratory Outpatient Clinic (MedicalUniversity Innsbruck, Internal Medicine II) from the PRECISE registry or fromother participating clinics at Medical University Innsbruck and via localadvertisement.
- Persistent respiratory symptoms for 3 months after infection (mMRC dyspnea score ≥ 1).
- Absence of obstructive or restrictive lung disease or unilateral diaphragmaticparesis.
- Medical history with symptoms compatible with DB as assessed by the physician ANDNijmegen cut-off score of >23 or reduced MIP. The last two conditions were chosento provide a readily accessible and objectifiable entry criterion at theinclusion visit.
- Age >= 18 years, < 50 years.
- Sufficient knowledge of German language for interaction during Yoga andcompletion of questionnaires. Inclusion criteria for participants with COPD
- Eligible patients will be recruited at the Respiratory Outpatient Clinic (MedicalUniversity Innsbruck).
- A postbronchodilator FEV1/FVC ratio less than 0,7 obtained in functional pulmonarytesting is required fo diagnosis of COPD (Global Initiative for Chronic ObstructiveLung Disease (GOLD) Science Committee, 2022).
- Persistent respiratory symptoms for 3 months (mMRC≥ 1).
- Absence of unilateral diaphragmatic paresis.
- Medical history with symptoms compatible with DB as assessed by the physician ANDNijmegen cut-off score of >23 or reduced MIP. The last two conditions were chosen toprovide a readily accessible and objectifiable entry criterion at the inclusion visit.
- Age >= 18 years, < 50 years
- Sufficient knowledge of German language for interaction during Yoga and completion ofquestionnaires Inclusion criteria for participants with somatic symptom disorder
- Eligible patients will be recruited at University Hospital for Psychiatry I and II,Medical University Innsbruck) and via local advertisement.
- Screening positive for somatic symptoms disorder with the following scores: SSD-12 ≥ 23, SSS-8 ≥ 9.
- Persistent respiratory symptoms for 3 months after infection (mMRC≥ 1).
- Absence of obstructive or restrictive lung disease or unilateral diaphragmaticparesis.
- Absence of medical history with symptoms compatible with DB as assessed by thephysician AND Nijmegen cut-off score of >23 or reduced MIP. The last two conditionswere chosen to provide a readily accessible and objectifiable entry criterion at theinclusion visit.
- Age >= 18 years, < 50 years.
- Sufficient knowledge of German language for interaction during Yoga and completion ofquestionnaires. Inclusion criteria for healthy participants
- Eligible participants will be recruited via local advertisement.
- Absence of significant active mental or somatic disorders
- Absence of persistent respiratory symptoms (mMRC< 1).
- Absence of obstructive or restrictive lung disease or unilateral diaphragmaticparesis.
- Absence of medical history with symptoms compatible with DB as assessed by thephysician AND Nijmegen questionnaire and MIP within normal limits..
- Age >= 18 years, < 50 years.
- Sufficient knowledge of German language for interaction during Yoga and completion ofquestionnaires.
Exclusion
Exclusion Criteria:
- Exclusion criteria for participants with post COVID condition
- Conditions precluding magnetic resonance imaging (MRI) such as metal implants inthe body (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
- Active psychiatric conditions interfering with study participation such aspsychosis or acute suicidality.
- Severe fatigue interfering with study participation.
- Previous evidence of structural brain abnormality on the structural MRI scan.
- Significant previous meditation or Yoga experience.
- Patients with known carotid stenosis >70% or cardiopulmonary contraindicationsfor tilt table and other cardiovascular autonomic function tests (e.g. Valsalvamaneuver, deep breathing, standing test). Exclusion criteria for participants with COPD
- Conditions precluding magnetic resonance imaging (MRI) such as metal implants in thebody (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
- Active psychiatric conditions interfering with study participation such as psychosisor acute suicidality.
- Severe fatigue interfering with study participation.
- Previous evidence of structural brain abnormality on the structural MRI scan.
- Medical history of post COVID condition.
- Significant previous meditation or Yoga experience.
- Patients with known carotid stenosis >70% or cardiopulmonary contraindications fortilt table and other cardiovascular autonomic function tests (e.g. Valsalva maneuver,deep breathing, standing test).
- Patients dependent on a long-term oxygen therapy (LTOT ) Exclusion criteria for participants with somatic symptom disorder
- Conditions precluding magnetic resonance imaging (MRI) such as metal implants in thebody (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
- Other active psychiatric conditions interfering with study participation such aspsychosis or acute suicidality.
- Severe fatigue interfering with study participation.
- Previous evidence of structural brain abnormality on the structural MRI scan.
- Medical history of post COVID condition.
- Significant previous meditation or Yoga experience.
- Patients with known carotid stenosis >70% or cardiopulmonary contraindications fortilt table and other cardiovascular autonomic function tests (e.g. Valsalva maneuver,deep breathing, standing test). Exclusion criteria for healthy participants
- Conditions precluding magnetic resonance imaging (MRI) such as metal implants in thebody (e.g., pacemakers, surgical devices), phobic anxiety, claustrophobia, orpregnancy.
- Active psychiatric conditions interfering with study participation such as psychosisor acute suicidality.
- Previous evidence of structural brain abnormality on the structural MRI scan.
- Medical history of post COVID condition.
- Significant previous meditation or Yoga experience.
- Patients with known carotid stenosis >70% or cardiopulmonary contraindications fortilt table and other cardiovascular autonomic function tests (e.g. Valsalva maneuver,deep breathing, standing test). legend: PRECISE = a study conducted with participants with post-COVID-19 condition at theMedical University of Innsbruck; mMRC score = modified medical research council score; DB =dysfunctional breathing; MIP = maximal inspiratory pressure; COPD = chronic obstructivepulmonary disease; FEV1/FVC = forced expiratory volume in one second/ forced vitalcapacity; SSD-12 = Somatic Symptom Disorder - B Criteria Scale; SSS-8 = Somatic SymptomScale - 8;
Study Design
Total Participants: 320
Treatment Group(s): 2
Primary Treatment: social contact
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
January 01, 2027
Connect with a study center
Medizinische Universität Innsbruck
Innsbruck, Tirol 6020
AustriaActive - Recruiting
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