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Reducing posttraumatic stress after severe sepsis in patients and their spouses

Reducing posttraumatic stress after severe sepsis in patients and their spouses - REPAIR

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010676
Enrollment
196
Registered
2016-06-14
Start date
2017-04-27
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F43.1

Interventions

Group 1: Therapist-guided, manualized, internet-based therapy for treating posttraumatic stress disorder in patients after severe sepsis and/or their spouses
clients complete two 50-minute written assignments per week over a 5-week period (10 assignments in total) Group 2: Waitlist control group

Sponsors

Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients after severe sepsis with intensive care > 5 days or spouses of patients with clinically relevant posttraumatic stress symptoms, trauma associated with intensive care for treatment of sepsis, fluent in written German, internet access

Exclusion criteria

Exclusion criteria: Patients without spouse, acute psychosis, suicidal intentions, use of neuroleptics, concurrent psychotherapeutic treatment

Design outcomes

Primary

MeasureTime frame
Symptom severity of posttraumatic stress (about 5 weeks after randomization; measured via the Posttraumatic stress disorder checklist [PCL-5])

Secondary

MeasureTime frame
Remission of PTSD (measured via the Clinician-Administered PTSD Scale [CAPS]), depression, anxiety, somatization (measured via the Brief Symptom Inventory-18 [BSI-18]), marital satisfaction (measured via the Relationship Assessment Scale [RAS]), health-related quality of life (measured via the EQ-5D-5L; all mentioned outcomes assessed at the end of treatment, 3, 6, and 12 months post-treatment), percentage of participants leaving the study early (during treatment phase) due to any reason; assessment of safety: Monitoring of suicidality and behavioral adverse effects

Countries

Austria, Germany, Switzerland

Contacts

Public ContactRomina Gawlytta

Universitätsklinikum Jena, Institut für Psychosoziale Medizin und Psychotherapie

romina.gawlytta@med.uni-jena.de+49 3641 935482

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 27, 2026