PTSD After ICU Survival - Caring for Patients With Traumatic Stress Sequelae Following Intensive Medical Care

NCT03315390 | Completed DMC

• 1 other identifier: GE 2073/8-1
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 2

Brief Summary

During the PICTURE trial a short narrative therapy (narrative exposure therapy adapted for primary care) for patients with posttraumatic stress disorder (PTSD) after intensive care treatment is to be carried out by their general practitioner (GP). During regular practice hours, this is often difficult. For this reason, we are investigating whether the regular treatment can be improved by a specially trained GP. The aim of the study is to investigate the effects and applicability of a short version of an established narrative therapy for patients with posttraumatic stress disorders after intensive medical treatment. Three months after discharge from the intensive care unit, the diagnosis of a PTSD symptoms is verified and the patients are randomized into two groups. In the treatment group, the physician will perform three 45-minute therapy sessions with the patient within 6 weeks. During the first session a list of the most intense events - both positive and negative - in the life of the patient is drawn on the basis of a life line, with the stay at the intensive care unit being one of these events. The second session deals with the experience during intensive care in detail, led by the GP. During the third session, another event from the patient's life will be discussed in the same manner. This way, the different components (cognitions, emotions, body reactions, context information) can be reconnected and classified into the patient's own biography. Between the therapy sessions, a conversation between the GP and the psychologist will take place to support the GP during the therapy. In order to monitor the patient's safety and compliance, standardized telephone calls between the patient and the GP practice are regularly carried out every 2-3 weeks in between therapy sessions up to the first data collection after 6 months (T1). In the control group there are three doctor-patient contacts, too, which content is based on the patient's symptoms. This group thus receives the standard therapy which is customary in practice.

Conditions

Stress Disorders, Post-Traumatic

Keywords

post-traumatic stress, primary health care, stress disorder

Outcome Measures

Primary Outcomes (1)

• Posttraumatic Stress

  absolute change in posttraumatic stress symptoms as measured by the Posttraumatic Stress Diagnostic Scale (PDS-5) total severity score; each of the 20 items refers to symptoms experienced in the past month and is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (more than 5 times per week/severe), total score range 0 - 80 points

  from baseline data collection to 6-month follow-up

Secondary Outcomes (7)

• Posttraumatic Stress

  from baseline data collection to 12-month follow-up

• Depression

  from baseline data collection to 6-month and 12-month follow-up

• Anxiety

  from baseline data collection to 6-month and 12-month follow-up

• Patient's self-rated health

  from baseline data collection to 6-month and 12-month follow-up

• Disability

  from baseline data collection to 6-month and 12-month follow-up

Study Arms (2)

Intervention-group

EXPERIMENTAL

Narrative Exposure Therapy (NET): for GP-practice adapted version of narrative exposure therapy during 3 sessions (à 45 minutes)

Other: "Narrative Exposure Therapy"-oriented intervention

iTAU group

ACTIVE COMPARATOR

Improved Treatment-as-usual: 3 GP consultations with patients according to guidelines and adapted to patients' needs

Other: improved treatment as usual (iTAU)

Interventions

"Narrative Exposure Therapy"-oriented intervention OTHER

Narrative Exposure Therapy (NET) in an Primary-care adapted Version in 3 sessions (S) 6 weeks (S1), 8 weeks (S2) and 12 weeks (S3) after baseline data collection at T0.

Intervention-group

improved treatment as usual (iTAU) OTHER

improved standard primary care for PTSD according to Guidelines, customized to patients' needs and symptoms during 3 consultations between T0 and T1

iTAU group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• GPs:

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• German Research Foundation: collaborator
• University of Konstanz: collaborator

Study Sites (2)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Ludwig-Maximilians-Universität München

München, 80336, Germany

Location

Related Publications (3)

• Gensichen J, Schmidt KFR, Sanftenberg L, Kosilek RP, Friemel CM, Beutel A, Dohmann J, Heintze C, Prescott HC, Reips UD, Schauer M, Lindemann D, Brettschneider C, Dreischulte T, Zwissler B, Elbert T; PICTURE study group. Effects of a general practitioner-led brief narrative exposure intervention on symptoms of post-traumatic stress disorder after intensive care (PICTURE): multicentre, observer blind, randomised controlled trial. BMJ. 2025 May 7;389:e082092. doi: 10.1136/bmj-2024-082092.

  PMID: 40335079 DERIVED

• Beutel A, Sanftenberg L, Friemel CM, Kosilek RP, Schauer M, Elbert T, Reips UD, Schubert T, Gehrke-Beck S, Schmidt K, Gensichen J; PICTURE study group. Patient perspectives on stress after ICU and a short primary care based psychological intervention - results from a qualitative sub-study of the PICTURE trial. BMC Prim Care. 2025 Jan 15;26(1):12. doi: 10.1186/s12875-024-02698-6.

  PMID: 39815198 DERIVED

• Gensichen J, Schultz S, Adrion C, Schmidt K, Schauer M, Lindemann D, Unruh N, Kosilek RP, Schneider A, Scherer M, Bergmann A, Heintze C, Joos S, Briegel J, Scherag A, Konig HH, Brettschneider C, Schulze TG, Mansmann U, Linde K, Luhmann D, Voigt K, Gehrke-Beck S, Koch R, Zwissler B, Schneider G, Gerlach H, Kluge S, Koch T, Walther A, Atmann O, Oltrogge J, Sauer M, Schnurr J, Elbert T; PICTURE Study Group. 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). Trials. 2018 Sep 10;19(1):480. doi: 10.1186/s13063-018-2853-7.

  PMID: 30201053 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jochen Gensichen, Prof. Dr.

  Institut für Allgemeinmedizin, LMU München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direktor am Institut für Allgemeinmedizin

Model Details: multi-center, observer-blinded, randomized, controlled trial with complex psychological intervention

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 20, 2017
• Study Start: October 21, 2018
• Primary Completion: August 30, 2023
• Study Completion: January 18, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available 01-01-2025.
• Access Criteria: Requests to be sent to the Principal Investigator for access to the anonymous participant data. Data will be made available to researchers whose proposed use of the data has been approved. Data will be made available for the advancement of medical research in line with a Data Use Agreement.

Locations

DE (2)