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A prospective non-randomized controlled trial testing the efficacy of psychotherapeutic inpatient treatment of Post-COVID-19 syndrome

A prospective non-randomized controlled trial testing the efficacy of psychotherapeutic inpatient treatment of Post-COVID-19 syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033562
Enrollment
60
Registered
2024-02-15
Start date
2023-05-15
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-covid syndrom

Interventions

Group 1: patients with post-covid condition in inpatient psychosomatic treatment Intervention: - Psychotherapy: individual therapy, psychoeducational guided open-ended interaction group, mindfulness t

Sponsors

Psychosomatische und Psychotherapeutische Abteilung, Universitätsklinikum Erlangen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) PCR-confirmed SARS-Cov-2 infection and subsequent PASC: complaints that are still present more than 12 weeks after the onset of SARS-Cov-2 infection and cannot be explained otherwise 2) Written informed consent to participate in the study 3) Sufficient knowledge of the German language to participate in the study 4) Treatment group: indication for inpatient psychosomatic treatment due to: - A clinically relevant psychiatric diagnosis - Limitations that significantly reduce the ability to manage everyday life (e.g. the ability to maintain daily structure) and/ or - Subjective stress so great that the quality of life and everyday resilience are significantly limited 5) Control group: depressive symptoms in self-assessment (PHQ-9 = 10)

Exclusion criteria

Exclusion criteria: - Severely physically impaired patients (predominantly bedridden) - Unique or main diagnosis of substance abuse (F10 – F19), schizophrenia, psychosis (F20 – F229) or organic psychiatric disorders (F00 – F09) - Suicidality - Control group: utilization of PASC-specific outpatient or inpatient psychotherapeutic treatment or psychosomatic rehabilitation during 5 weeks of treatment

Design outcomes

Primary

MeasureTime frame
symptoms of post-covid syndrom assessed with the post-covid syndrom score (PCS)

Secondary

MeasureTime frame
Measurement time points: - Time of admission to inpatient setting (T0) - Time of discharge from the inpatient setting (T1) - Catamnesis (after 6 months) (T2) measuring instruments: - web-based questionnaire battery (T0, T1 and T2): Fatigue assessed with the Fatigue Severity Scale (FSS) Post-exertionel-malaise measured with the PEM Sleep disorders measured with Insomnia Severtiy Index (ISI) Depression assessed with the Patient Health Questionnaire for depression (PHQ-15) Generalized anxiety measured with the Generalized Anxiety Disorder (GAD-7) Somatic symptoms measured with the Patient Health Questionnaire (PHQ-9) Social support measured with the Enriched Social Support Inventory (ESSI, social support) Sense of Coherence measured with the Sense of Coherence Scale (SOC-3) Subjective experience of stress measured with the Perceived Stress Scale (PSS -4) Psychological stress in somatic stress disorder assessed with the Somatic Symptom Disorder (SSD-12) Patient Competence in Coping with Illness Questionnaire (PUK-2) (= a version of the Patient Competence in Coping with Cancer Questionnaire, PUK, adapted for post-Covid symptoms) In addition, socio-demographic data, medication and use of previous treatments as well as data on the patient's health behavior (e.g. smoking, alcohol consumption, etc.) are collected - on presentation in the inpatient setting and on discharge (T0 and T1), detailed laboratory parametric examinations (differential blood count, immunological tests to clarify inflammation parameters) and examinations of lung function and heart function (ECG) are also carried out - At T2 (catamnesis), patients also receive the following questionnaires: Questions on satisfaction with the psychosomatic inpatient treatment, ability to work, questions on personality and use of post-Covid-specific treatments (medication, etc.) in the meantime (self-constructed) - neuropsychological examination: Assessment of declarative verbal

Countries

Germany

Contacts

Public ContactYesim Erim

Psychosomatische und Psychotherapeutische Abteilung, Universitätsklinikum Erlangen

yesim.erim@uk-erlangen.de09131 8535928

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026