U09.9
Conditions
Interventions
Group 1: control group (receives standard treatment
TAU)
Group 2: intervention group JOURNAL: in addition to standard treatment (TAU), realistic-optimistic expectations should be formulated and written down in a journal
Group 3: intervention group FRAM
an imagination exercise is used
Sponsors
Klinik für Psychosomatische Medizin und Psychotherapie Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with Post-COVID in one of the participating psychosomatic rehabilitation clinics, written declaration of consent to participate in the study, sufficient knowledge of German.
Exclusion criteria
Exclusion criteria: - no Post-COVID syndrome - Written informed consent for study participation not given - insufficient knowledge of German - current psychotic symptoms - substance dependence and abuse - organic brain diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study is a longitudinal survey in which patients are interviewed and examined at three points in time: At the beginning (T0) and end (T1) of the rehabilitation program and after 6 months (T2). The outcome variables are collected using standardized questionnaires and examinations based on current studies. The main target variables are the therapeutic outcomes, which are operationalized by clinical assessment, questionnaires and tests. As the predominant symptoms in post-Covid patients can vary, the WHO Disability Assessment Schedule 2.0 (WHO DAS 2.0) as a measure of general condition and functioning and the Work Ability Index (WAI) as a proxy for earning capacity are considered the most important outcomes. In addition, sick days and work volume (full/part-time) are recorded after 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary target criteria are symptom-related questionnaires and objective measures to record the improvement in symptoms and mediating factors (mediators). These are operationalized by questionnaire scores or objective data such as the distance walked within 6 min (6-min walk test), blood pressure, pulse parameters and cognitive performance (memory span, reaction time, inhibition ability). Questionnaires: - Regensburg COVID documentation (ReCoRD; recording of 25 COVID-19 and post-Covid symptoms; 25 items) - General state of health, level of functioning and participation (WHO Disability Assessment Schedule 2.0; short form 12 items) - Somatoform complaints and B-symptoms (Patient's Health Questionnaire, PHQ-15; Somatic Symptom Disorder, SSD-12; 27 items in total) - Depressiveness (PHQ-9, 9 items) - Anxiety (Generalized Anxiety Disorder, GAD-7, 7 items) - Fatigue (Fatigue Scale for Motor Function and Cognition, FSMC, 20 items) - Work Ability Index (WAI; 7 items) - Post-exertional malaise (DePaul Symptom Questionnaire, 10 items) - Self-efficacy expectations (SWE, 10 items) - Expectations of rehab and the rehab outcome (TEX-Q, 19 items) - Quality of life and general state of health (2 items) - Transdiagnostic personality structure (OPD-SFK, 12 items) - Perfectionism (FMPS-D; 35 items) Objective measures: - Tests on the PC and on paper to assess cognitive performance such as attention span, memory performance and reaction times (Corsi Span Test, Color Stroop Test, Wisconsin Card Sorting Inspired Task, d2 test) (approx. 15-20 min in total) - 6-min walking test (approx. 10 min in total) - Blood pressure (3 min) - 5-min pulse measurement at rest (heart rate variability) (approx. 7 min) Objective measures: - Clinical assessment of the rehabilitation outcome and the ability to work and earn by the practitioner (evaluation of the final report). | — |
Countries
Germany
Contacts
Public ContactKatja Weimer
Klinik für Psychosomatische Medizin und Psychotherapie Universitätsklinikum Ulm
Outcome results
None listed