An interventional study of "Narrative Exposure Therapy"-oriented intervention and improved treatment as usual (iTAU) in Stress Disorders, Post-Traumatic, sponsored by Ludwig-Maximilians - University of Munich. Completed at 2 sites in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment
Among 52 studies in Stress Disorders, Post-Traumatic with a site in Germany — 7 open to participants now, 7 under way, none of them phase 3. Stress Disorders, Post-Traumatic · Germany.
Among the 52 studies in Stress Disorders, Post-Traumatic with a site in Germany, this one has the largest enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2018, is one of 34 with no phase, and was the 31st registered.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
Browse Stress Disorders, Post-Traumatic studies →7 of the 52 studies in Stress Disorders, Post-Traumatic with a site in Germany are open now. Recruiting first, the newest first:
Eva Heim · Sites in Germany, Switzerland
University Children's Hospital, Zurich · Sites in Germany, Switzerland
Malek Bajbouj · Sites in Germany
Charite University, Berlin, Germany · Sites in Germany
Medicalschool Hamburg · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 417 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 205 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 1 · Phase 4 1
First in 2002; this study’s year is marked. 4 started in 2018.
This study's enrollment of 319 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Median enrollment 79 across the 42 interventional studies, 277 across the 10 observational. Of the 37 that completed or were terminated, 3 (8%) have results posted.
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2 of 52 have an industry lead sponsor. The 10 most frequent:
Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Ludwig-Maximilians - University of Munich has 5 studies filed under Stress Disorders, Post-Traumatic — fewer than ten, so there is no comparison to draw.
2 of the studies in Stress Disorders, Post-Traumatic with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06806267Malek BajboujStudy of the Effectiveness of VRET Combined With tDCS in the Treatment of PTSD in Ukrainian Veterans and Civilians | 2027-02-28 |
| NCT07607808University Hospital, AachenPsychological Stress and Support Needs of Volunteer First Responders After Smartphone-based Cardiac Arrest Alerts | 2027-05-01 |
Among the 52 studies in Stress Disorders, Post-Traumatic with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Patients:
Inclusion Criteria: Symptoms for Posttraumatic Stress disorder (PDS-5 [2016] Score ≥ 15 (20-item Posttraumatic Diagnostic Scale for the (DSM) -5)); written 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, \<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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Improved Treatment-as-usual: 3 GP consultations with patients according to guidelines and adapted to patients' needs
Other: improved treatment as usual (iTAU)
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.
improved standard primary care for PTSD according to Guidelines, customized to patients' needs and symptoms during 3 consultations between T0 and T1
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
Time frame: from baseline data collection to 6-month follow-up
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 sum score range 0 - 80 Points, with a high score indicating severe impairment
Time frame: from baseline data collection to 12-month follow-up
Depression
absolute change in depressive symptoms experienced over the last 2 weeks as measured by the Patient Health Questionnaire (PHQ)-9 total score; each of the 9 items items is scored from 0 (not at all) to 3 (nearly every day); total sum score range from 0 to 27 points, with a high score indicating severe impairment
Time frame: from baseline data collection to 6-month and 12-month follow-up
Anxiety
absolute change in anxiety severity and impairment as measured by the Overall Anxiety Severity and Impairment Scale (OASIS) total score; there are 5 response options for each of the 5 items, which are coded from 0 to 4; total sum score range from 0 (no anxiety) to 20 points, with a high score indicating severe impairment
Time frame: from baseline data collection to 6-month and 12-month follow-up
Patient's self-rated health
absolute change in health-related quality of life as measured by the EuroQol - 5 Dimensions (5D) - 5 Level (EQ-5D-5L) Visual Analogue Scale (VAS); the EQ-5D-5L VAS is a thermometer-like rating scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: from baseline data collection to 6-month and 12-month follow-up
Disability
absolute change in disability as measured by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 - short version total score (12-item Version); range from 0 to 100, with higher scores indicating higher Levels of disability
Time frame: from baseline data collection to 6-month and 12-month follow-up
Patient Activation Measure
absolute change in active participation of patients and the self-management of their state of health as measured by the Patient Activation Measure-13 (PAM-13) total score (13-items); each item scores from 1 to 4 (1 = strongly disagree, 2= disagree, 3=agree, 4= strongly agree; for the fifth item only additionally 5= not applicable); Evaluation is made by adding the raw values with a range of 13 - 52; sum-scale will be calibrated to a 0 to 100 metric
Time frame: from baseline data collection to 6-month and 12-month follow-up
Cost-effectiveness
absolute change in health-related costs as measured by the modified Client Sociodemographic and Service Receipt Inventory (CSSRI) based on direct and indirect costs
Time frame: from baseline data collection to 6-month and 12-month follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Yes. Deidentified participant data, data dictionary. The data will only be made available to scientific institutions that submit a methodologically meaningful evaluation proposal. Furthermore, applicants must sign a data access agreement.
Supporting information: Study protocol, Statistical analysis plan
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.
Ran from Oct 2018 to primary completion in Aug 2023, 58 months.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 58 months is above that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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