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)
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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). / 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; PICTURE Study Group.
in: TRIALS, Jahrgang 19, Nr. 1, 10.09.2018, S. 480.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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)
AU - Gensichen, Jochen
AU - Schultz, Susanne
AU - Adrion, Christine
AU - Schmidt, Konrad
AU - Schauer, Maggie
AU - Lindemann, Daniela
AU - Unruh, Natalia
AU - Kosilek, Robert P
AU - Schneider, Antonius
AU - Scherer, Martin
AU - Bergmann, Antje
AU - Heintze, Christoph
AU - Joos, Stefanie
AU - Briegel, Josef
AU - Scherag, Andre
AU - König, Hans-Helmut
AU - Brettschneider, Christian
AU - Schulze, Thomas G
AU - Mansmann, Ulrich
AU - Linde, Klaus
AU - Lühmann, Dagmar
AU - Voigt, Karen
AU - Gehrke-Beck, Sabine
AU - Koch, Roland
AU - Zwissler, Bernhard
AU - Schneider, Gerhard
AU - Gerlach, Herwig
AU - Kluge, Stefan
AU - Koch, Thea
AU - Walther, Andreas
AU - Atmann, Oxana
AU - Oltrogge, Jan
AU - Sauer, Maik
AU - Schnurr, Julia
AU - Elbert, Thomas
AU - PICTURE Study Group
PY - 2018/9/10
Y1 - 2018/9/10
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1186/s13063-018-2853-7
DO - 10.1186/s13063-018-2853-7
M3 - SCORING: Journal article
C2 - 30201053
VL - 19
SP - 480
JO - TRIALS
JF - TRIALS
SN - 1745-6215
IS - 1
ER -