Clinical trial NCT03315390: PTSD After ICU Survival - Caring for Patients With Traumatic Stress Sequelae Following Intensive Medical Care
Official title: PTSD After ICU Survival - Caring for Patients With Traumatic Stress Sequelae Following Intensive Medical Care - a Multi-Center, Observer-blinded, Randomized, Controlled Trial With a Psychological Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: post-traumatic stress, primary health care, stress disorder
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University of Konstanz
First posted: 2017-10-20
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, observer-blinded, randomized, controlled trial with complex psychological intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: Patients:

Inclusion Criteria: Symptoms for Posttraumatic Stress disorder (PDS-5 \[2016\] Score ≥ 15 (20-item Posttraumatic Diagnostic Scale for the Diagnostic and Statistical Manual of Mental Disorders (DSM) -5)); written informed consent of the patient is present; sufficient knowledge of the German language in word and writing; patients must be able to follow study instructions and likely to attend and complete all required visits and telephone surveys.

Exclusion criteria: physical or psychiatric condition which may put the patient at risk, may confound the trial results or may interfere with the patient's participation in this trial; known or persistent abuse of medication, drugs or alcohol as assessed by the GP; major depression (PHQ-9 score ≥ 23), acute suicidality, life expectancy \<6 months at T0; already receiving another psychotherapeutic trauma therapy such as Eye Movement Desensitization and Reprocessing (EDMR) or Cognitive behavioral therapy (CBT) at T0; any neuroleptic, anticholinergic or anti-epileptic drugs as permanent medication for specific psychiatric disease within the last two weeks prior to baseline;

GPs:

Inclusion criteria: providing family doctor services for ≥ 2 years within the German statutory health care system, holding a certificate for "Basic Psychosomatic Care" (German Medical Association 2001), alternatively, GP has to be a family doctor within the German statutory health care system for ≥ 5 years with adequate psychological, psychosomatic or psychiatric qualification; informed consent of the GP is present Exclusion criteria: GPs: \> 80% of patients with a specific mental condition

Primary outcomes:
measure: Posttraumatic Stress
timeFrame: from baseline data collection to 6-month follow-up
Secondary outcomes:
measure: Posttraumatic Stress
timeFrame: from baseline data collection to 12-month follow-up
measure: Depression
timeFrame: from baseline data collection to 6-month and 12-month follow-up
measure: Anxiety
timeFrame: from baseline data collection to 6-month and 12-month follow-up
measure: Patient's self-rated health
timeFrame: from baseline data collection to 6-month and 12-month follow-up
measure: Disability
timeFrame: from baseline data collection to 6-month and 12-month follow-up
measure: Patient Activation Measure
timeFrame: from baseline data collection to 6-month and 12-month follow-up
measure: Cost-effectiveness
timeFrame: from baseline data collection to 6-month and 12-month follow-up
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: München
country: Germany
facility: Ludwig-Maximilians-Universität München
Study officials:
affiliation: Institut für Allgemeinmedizin, LMU München
name: Jochen Gensichen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.