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Post COVID-19 intervention in behavioural medicine – exploratory trial

Post COVID-19 intervention in behavioural medicine – exploratory trial - POSITIV

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030565
Enrollment
60
Registered
2022-12-22
Start date
2022-10-05
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-19 condition F45.9

Interventions

Group 1: cognitive behavioral therapy based psychotherapeutic group intervention and mobile biofeedback training Group 2: optimized treatment as usual

Sponsors

Klinik für Psychosomatische Medizin und Psychotherapie LVR-Universitätsklinik Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Changes in self-efficacy

Secondary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026