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

NCT ID: NCT03315390

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-21
• Study Completion Date: 2024-01-18

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.

Detailed Description

The treatment of patients with posttraumatic stress disorder (PTSD) in general practice is usually symptom-oriented and does not necessarily involve a proactive approach. Instead, PTSD is often not verbalized, and patients are treated symptomatically or referred to specialists / psychologists, often associated with long waiting times.

We are conducting this trial to investigate a short, narrative exposure therapy (NET) adapted for the use by general practitioners (GPs) in patients with PTSD symptoms after intensive care treatment. NET is the only method that has proved to be successful in PTSD patients, even when used by paramedics, nurses or local counselors, and is therefore also suitable for physicians without extensive psychological training The aim of our study is 1) to examine the feasibility and safety of a NET-oriented therapy in primary care, and 2) to examine the effects of the NET-oriented therapy in comparison to standard care by collecting results 6 and 12 months after diagnosis.

The intervention is being investigated in a randomized controlled, observer-blinded multicenter study with two arms. 318 patients (and their GPs) are included in 2 locations (Munich & Berlin) in Germany.

3 months after discharge from intensive care unit, the diagnosis of PTSD symptoms in participants is verified by the GP and patients are randomly assigned to either treatment group or the control group.

In the treatment group, the GPs receive training in executing narrative exposure therapy by specialized psychologists. The doctors of this group will hold three 45-minute therapy sessions with their patient within 6 weeks. During the first session a list of the most intense events - both positive and negative - is drawn up in the life of the patient on the basis of a life line, with the stay at the intensive care unit being one of these events. During the second session the experience in the intensive care unit will be discussed in detail, led by the GP. During the third session, another event from the patient's life is dealt with 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 therapy sessions, the GP and the psychologist will schedule a conversation for support and supervision of the GP during the therapy. In order to monitor the patient's safety and compliance, standardized telephone calls between the patient and the GP's practice are regularly carried out every two-three weeks in between the therapies sessions and up to the first data collection after six months (T1).

In the control group, the GPs receive training in treatment of PTSD according to guidelines. In this group, there are also 3 consultations between GP and patient. However, the content of these consultations is based on the patient's symptoms. This group thus receives the standard therapy which is customary in practice.

The data necessary for the evaluation of the intervention is collected 6 and 12 months after the first GP appointment, during which the diagnosis was verified.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention-group

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

Group Type: EXPERIMENTAL

"Narrative Exposure Therapy"-oriented intervention

Intervention Type: 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.

iTAU group

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

Group Type: ACTIVE_COMPARATOR

improved treatment as usual (iTAU)

Intervention Type: OTHER

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

Interventions

"Narrative Exposure Therapy"-oriented intervention

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 Type: OTHER

improved treatment as usual (iTAU)

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

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

GPs:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

University of Konstanz

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Jochen Gensichen

Direktor am Institut für Allgemeinmedizin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jochen Gensichen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institut für Allgemeinmedizin, LMU München

Locations

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Ludwig-Maximilians-Universität München

München, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 40335079 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39815198 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30201053 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GE 2073/8-1

Identifier Type: -

Identifier Source: org_study_id