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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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)

Authors: Jochen Gensichen, Susanne Schultz, Christine Adrion, Konrad Schmidt, Maggie Schauer, Daniela Lindemann, Natalia Unruh, Robert P. Kosilek, Antonius Schneider, Martin Scherer, Antje Bergmann, Christoph Heintze, Stefanie Joos, Josef Briegel, Andre Scherag, Hans-Helmut König, Christian Brettschneider, Thomas G. Schulze, Ulrich Mansmann, Klaus Linde, Dagmar Lühmann, Karen Voigt, Sabine Gehrke-Beck, Roland Koch, Bernhard Zwissler, Gerhard Schneider, Herwig Gerlach, Stefan Kluge, Thea Koch, Andreas Walther, Oxana Atmann, Jan Oltrogge, Maik Sauer, Julia Schnurr, Thomas Elbert, on behalf of the PICTURE Study Group

Published in: Trials | Issue 1/2018

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Abstract

Background

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.

Methods/design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov, NCT03315390. Registered on 10 October 2017.
German Clinical Trials Register, DRKS00012589. Registered on 17 October 2017.
Appendix
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Metadata
Title
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)
Authors
Jochen Gensichen
Susanne Schultz
Christine Adrion
Konrad Schmidt
Maggie Schauer
Daniela Lindemann
Natalia Unruh
Robert P. Kosilek
Antonius Schneider
Martin Scherer
Antje Bergmann
Christoph Heintze
Stefanie Joos
Josef Briegel
Andre Scherag
Hans-Helmut König
Christian Brettschneider
Thomas G. Schulze
Ulrich Mansmann
Klaus Linde
Dagmar Lühmann
Karen Voigt
Sabine Gehrke-Beck
Roland Koch
Bernhard Zwissler
Gerhard Schneider
Herwig Gerlach
Stefan Kluge
Thea Koch
Andreas Walther
Oxana Atmann
Jan Oltrogge
Maik Sauer
Julia Schnurr
Thomas Elbert
on behalf of the PICTURE Study Group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2853-7

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