Effect of a combined brief narrative exposure therapy with case management versus treatment as usual in primary care for patients with traumatic stress sequelae following intensive care medicine: study protocol for a multicenter randomized controlled trial (PICTURE)

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; p. 480
• Main Authors: Gensichen, Jochen, Schultz, Susanne, Adrion, Christine, Schmidt, Konrad, Schauer, Maggie, Lindemann, Daniela, Unruh, Natalia, Kosilek, Robert P, Schneider, Antonius, Scherer, Martin, Bergmann, Antje, Heintze, Christoph, Joos, Stefanie, Briegel, Josef, Scherag, Andre, König, Hans-Helmut, Brettschneider, Christian, Schulze, Thomas G, Mansmann, Ulrich, Linde, Klaus, Lühmann, Dagmar, Voigt, Karen, Gehrke-Beck, Sabine, Koch, Roland, Zwissler, Bernhard, Schneider, Gerhard, Gerlach, Herwig, Kluge, Stefan, Koch, Thea, Walther, Andreas, Atmann, Oxana, Oltrogge, Jan, Sauer, Maik, Schnurr, Julia, Elbert, Thomas
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 10-09-2018; BioMed Central; BMC
• Subjects: Care and treatment; Case Management; Clinical decision making; Comparative analysis; Complications and side effects; Critical Care - methods; Critical Care - psychology; Critical care medicine; Exposure therapy; Family physicians; Germany; Humans; Informed consent; Intensive care; Intensive care (MeSH); Intervention; Life expectancy; Medical case management; Methods; Multicenter Studies as Topic; Narrative Therapy - methods; Non-pharmacological (NON-Mesh); Patient outcomes; Patient safety; Post traumatic stress disorder; Primary care; Primary health care; Primary health care (MeSH); Primary Health Care - methods; Psychotherapy; Quality of life; Questionnaires; Randomized controlled trial (MeSH); Randomized Controlled Trials as Topic; Risk factors; Sepsis; Severity of Illness Index; Stress disorders (MeSH); Stress Disorders, Post-Traumatic - diagnosis; Stress Disorders, Post-Traumatic - psychology; Stress Disorders, Post-Traumatic - therapy; Study Protocol; Time Factors; Treatment Outcome; Ventilators; Germany; Intensive care (MeSH); Stress disorders (MeSH); Non-pharmacological (NON-Mesh); Primary health care (MeSH); Randomized controlled trial (MeSH)
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2853-7

Traumatic events like critical illness and intensive care are threats to life and bodily integrity and pose a risk factor for posttraumatic stress disorder (PTSD). PTSD affects the quality of life and morbidity and may increase health-care costs. Limited access to specialist care results in PTSD patients being treated in primary care settings. Narrative exposure therapy (NET) is based on the principles of cognitive behavioral therapy and has shown positive effects when delivered by health-care professionals other than psychologists. The primary aims of the PICTURE trial (from "PTSD after ICU survival") are to investigate the effectiveness and applicability of NET adapted for primary care with case management in adults diagnosed with PTSD after intensive care.
This is an investigator-initiated, multi-center, primary care-based, randomized controlled two-arm parallel group, observer-blinded superiority trial conducted throughout Germany. In total, 340 adult patients with a total score of at least 20 points on the posttraumatic diagnostic scale (PDS-5) 3 months after receiving intensive care treatment will be equally randomized to two groups: NET combined with case management and improved treatment as usual (iTAU). All primary care physicians (PCPs) involved will be instructed in the diagnosis and treatment of PTSD according to current German guidelines. PCPs in the iTAU group will deliver usual care during three consultations. In the experimental group, PCPs will additionally be trained to deliver an adapted version of NET (three sessions) supported by phone-based case management by a medical assistant. At 6 and 12 months after randomization, structured blinded telephone interviews will assess patient-reported outcomes. The primary composite endpoint is the absolute change from baseline at month 6 in PTSD symptom severity measured by the PDS-5 total score, which also incorporates the death of any study patients. Secondary outcomes cover the domains depression, anxiety, disability, health-related quality-of-life, and cost-effectiveness. The principal analysis is by intention to treat.
If the superiority of the experimental intervention over usual care can be demonstrated, the combination of brief NET and case management could be a treatment option to relieve PTSD-related symptoms and to improve primary care after intensive care.
ClinicalTrials.gov, NCT03315390 . Registered on 10 October 2017. German Clinical Trials Register, DRKS00012589 . Registered on 17 October 2017.