Reducing posttraumatic stress after severe sepsis in patients and their spouses

Phase 2

• Conditions: Post-traumatic stress disorder; F43.1

• Registration Number: DRKS00010676
• Lead Sponsor: Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Study Completion: 2019-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 34

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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]), <br>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