Post COVID-19 intervention in behavioural medicine – exploratory trial

Not Applicable

• Conditions: Post COVID-19 condition; F45.9; Somatoform disorder, unspecified

• Registration Number: DRKS00030565
• Lead Sponsor: Klinik für Psychosomatische Medizin und Psychotherapie LVR-Universitätsklinik Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

legal age;
Adequate knowledge of the German language which allows an active participation in psychotherapeutic interventions;
Fulfillment of diagnostic criteria for somatic symptom disorder (DSM-5 diagnostic criteria) on the base of a Post COVID-19 Condition (WHO Delphi Consensus diagnostic criteria);
Indication for an outpatient treatment;
Informed consent of the patient for the study

Exclusion Criteria

Not meeting one or more inclusion criteria;
The responsible therapist decides that an outpatient psychotherapy is not indicated at the moment and/or that other (e.g. inpatient, day-care) treatments are indicated as a priority. To this purpose, he/she applies the criteria usual in his/her practice.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post COVID-19 symptoms at post intervention (T1)

Secondary Outcome Measures

Name	Time	Method
quality of life, self-efficacy, distress, symptoms of a somatic symptoms disorder, depression, anxiety, post COVID-19 symptoms over four assessment points and time to dropout (T0 – T4). Assessment of safety: monitoring/reporting of adverse events