PTSD after ICU Caring for Patients with Traumatic Stress Sequelae following Intensive Medical Care
Organizational Data
- DRKS-ID:
- DRKS00012589
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2017-10-17
- Last update in DRKS:
- 2024-01-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
PICTURE
URL of the study
Brief summary in lay language
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 efficacy 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 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.
Brief summary in scientific language
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) with PTSD-patients 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 efficacy of the NET-oriented therapy in comparison to standard care by collecting long-term 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 two locations in Germany (Munich & Berlin). Three months after discharge from intensive care unit, the diagnosis of PTSD 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 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 2-3 weeks in between the therapies sessions and up to the first data collection after 6 months (T1). In the control group, the GPs receive training in treatment of PTSD according to guidelines. In this group, there are also three 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.
Health condition or problem studied
- ICD10:
- F43.1 - Post-traumatic stress disorder
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Patients in the intervention group receive a for GP-practice adapted version of narrative exposure therapy during 3 sessions (S) à 45 minutes each. The sessions take place 6 weeks (S1), 8 weeks (S2) and 12 weeks (S3) after baseline data collection at T0. S 1: Structured diagnosis of posttraumatic symptoms and creation of a life line, psychoeducation and relevant life events, the patient is informed about the symptoms and the treatment procedure. S 2: narrative exposure, led by the GP, with focus on experiences during the stay in the intensive care unit S 3: narrative exposure of another traumatic life event. 7 regular telephone contacts between S2 and S3 up to the assessment of the primary endpoint at T1 to support the effect of the therapy as well as for trauma monitoring
- Arm 2:
- 3 GP cconsultations with patients between T0 and T1: standard primary care for PTSD according to guidelines, customized to patients' needs and symptoms.
Endpoints
- Primary outcome:
- total change in posttraumatic stress symptoms, measured with the Posttraumatic Stress Diagnostic Scale (PDS-5 total severity score) at T1, i.e. 6 month after baseline data collection and 9 month after ICU discharge.
- Secondary outcome:
- Secondary endpoints are collected 6 months (T1) and 12 months (T2) after baseline data collection; Secondary endpoint at T2 is posttraumatic stress (assessed per PDS-5 total severity score); secondary endpoints at T1 and T2 are depression (assessed per PHQ-9), anxiety disorder (assessed per OASIS), health-related quality of life (assessed per EQ- 5L), overall health status (assessed per WHODAS 2.0), patient activity (assessed per PAM), costs of health care (assessed per CSSRI)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Ludwig-Maximillians-Universität München München
- University medical center Charité - Universitätsmedizin Berlin Berlin
Recruitment period and number of participants
- Planned study start date:
- 2017-10-23
- Actual study start date:
- 2018-10-22
- Planned study completion date:
- 2023-12-31
- Actual Study Completion Date:
- 2024-01-18
- Target Sample Size:
- 340
- Final Sample Size:
- 318
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 85 Years
- Additional Inclusion Criteria:
- patients: mechanical ventilation during intensive care treatment; sequential organ failure assessment score (max. SOFA Score ≥ 6); cognition (Six-Item-Screener ≥3); posttraumatic stress disorder is confirmed (PDS-5 [2016] Score ≥ 15 (20-item Posttraumatic Diagnostic Scale for DSM-5)); male and female patients aged 18-85 years; life expectance ≥6 months at T0; informed consent of the patient is present; sufficient knowledge of the German language in word and writing GPs: providing family doctor services for >2 years within the German statutory health care system, holding a certificate for “Basic Psychosomatic Care” (Bundesärztekammer 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
Patients: 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; abuse of medication, drugs or alcohol; major depression (PHQ-9 score >/=23), acute suicidality, life expectancy <6 months at T0; already receiving another psychotherapeutic trauma therapy such as EDMR or CBT at T0; any neuroleptic, anticholinergic or anti-epileptic drugs as permanent medication for specific psychiatric disease within 2 weeks prior to baseline; GPs: > 80% of patients with a specific mental condition
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum der Ludwig-Maximilians-Universität MünchenProf. Dr. Markus M. LerchMarchioninistraße 1581377 MünchenGermany
- Telephone:
- 089/4400 72101
- Fax:
- 089/4400 72102
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.lmu-klinikum.de/das-klinikum/wir-uber-uns/vorstand/5820a64f87bd3fdc#:~:text=Der%20%C3%84rztliche%20Direktor%20Professor%20Dr,vertritt%20das%20Klinikum%20nach%20au%C3%9Fen.
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für AllgemeinmedizinLudwig-Maximilians-Universität MünchenProf. Dr. med. Dipl.-Päd. Jochen GensichenNußbaumstr. 580336 MünchenGermany
- Telephone:
- 089/4400 54479
- Fax:
- 089/4400 53520
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.med.uni-muenchen.de/personen/team/jochen-gensichen/index.html
Contact for Public Queries
- Address:
- Institut für AllgemeinmedizinLudwig-Maximilians-Universität MünchenCampus InnenstadtProf. Jochen GensichenNußbaumstr. 580336 MünchenGermany
- Telephone:
- 089/4400 54479
- Fax:
- 089/4400 53520
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-muenchen.de/Institut-fuer-Allgemeinmedizin/de/index.html
Principal Investigator
- Address:
- Institut für AllgemeinmedizinLudwig-Maximilians-Universität MünchenProf. Dr. med. Dipl.-Päd. Jochen GensichenNußbaumstr. 580336 MünchenGermany
- Telephone:
- 089/4400 54479
- Fax:
- 089/4400 53520
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.med.uni-muenchen.de/personen/team/jochen-gensichen/index.html
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-06-13
- Ethics committee number:
- 17-436
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-09-20
Further identification numbers
- Other primary registry ID:
- NCT03315390 - ClinTrials.gov
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Yes. Deidentified participant data and data dictionary. Requests are 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.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- Statistischer Analyseplan
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- 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, König HH, Brettschneider C, Schulze TG, Mansmann U, Linde K, Lühmann 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; PMCID: PMC6131807.
- Sanftenberg L, Beutel A, Friemel CM, Kosilek RP, Schauer M, Elbert T, Reips UD, Gehrke-Beck S, Schubert T, Schmidt K, Gensichen J; PICTURE-study team. Barriers and opportunities for implementation of a brief psychological intervention for post-ICU mental distress in the primary care setting - results from a qualitative sub-study of the PICTURE trial. BMC Prim Care. 2023 May 6;24(1):113. doi: 10.1186/s12875-023-02046-0.
- Date of first publication of study results:
- 2023-05-06
- DRKS entry published for the first time with results:
- 2023-07-21
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry