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)

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.

Keywords: Intensive care (MeSH); Non-pharmacological (NON-Mesh); Primary health care (MeSH); Randomized controlled trial (MeSH); Stress disorders (MeSH).

Fig. 1

Study flow chart of the PICTURE trial: graphical depiction of study activities and components of intervention for both arms. BL baseline, GCP good clinical practice, GP general practitioner, ICU intensive care unit, ITC investigator trial center, MA medical assistant, Pat. participant, PDS Posttraumatic Stress Diagnostic Scale, PTSD posttraumatic stress disorder

Fig. 2

Standard protocol items (SPIRIT) for the PICTURE trial: schedule of enrolment, intervention, and assessments with their pre-planned time points T1 to T2. CSSRI Client Sociographic and Service Inventory, EQ-5D-5L Five-dimension Five-level EuroQol, ICU intensive care unit, iTAU improved treatment as usual, NET Narrative exposure therapy, OASIS Overall Anxiety Severity and Impairment Scale, PAM Patient Activation Measure, PC-PTSD Primary Care Posttraumatic Stress Disorder Screen, PCP primary care physician, PDS Posttraumatic Stress Diagnostic Scale, PHQ Patient health questionnaire, SAE serious adverse event, SIS Six-item Screener, SOFA Sequential Organ Failure Assessment, WHODAS World Health Organization Assessment Schedule