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Stress Disorders, Post-TraumaticPICTURENCT03315390

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

A study testing "Narrative Exposure Therapy"-oriented intervention and improved treatment as usual (iTAU) in people with Stress Disorders, Post-Traumatic, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
"Narrative Exposure Therapy"-oriented intervention and improved treatment as usual (iTAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
2 sitesGermany
Study dates
21 Oct 2018to 18 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Ludwig-Maximilians-Universität München

    München, 80336

Other trials in Germany

About this study

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

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.

Read more

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.

Read the 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.

Being tested
"Narrative Exposure Therapy"-oriented intervention, improved treatment as usual (iTAU)
Keywords
post-traumatic stress, primary health care, stress disorder
Medical subject headings
Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Narrative Exposure Therapy"-oriented interventionOther

    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 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

Study groups in NCT03315390
Study groupRoleWhat they receive
Intervention-groupExperimentalNarrative Exposure Therapy (NET): for GP-practice adapted version of narrative exposure therapy during 3 sessions (à 45 minutes)
Receives: Other: "Narrative Exposure Therapy"-oriented intervention
iTAU groupActive comparatorImproved Treatment-as-usual: 3 GP consultations with patients according to guidelines and adapted to patients' needs
Receives: Other: improved treatment as usual (iTAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from baseline data collection to 6-month follow-up

Secondary outcomes (7)

  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 sum score range 0 - 80 Points, with a high score indicating severe impairment

    Measured: from baseline data collection to 12-month follow-up

  2. 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

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

  3. 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

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

  4. 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).

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

  5. 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

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

  6. 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

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

  7. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2017
  2. Study start21 Oct 2018
  3. Primary completion30 Aug 2023
  4. Study completion18 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multi-center, observer-blinded, randomized, controlled trial with complex psychological intervention
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03315390
Sponsor's protocol ID
GE 2073/8-1
Acronym
PICTURE
Status last verified
Apr 2025
First submitted
10 Oct 2017
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Schubert TM, Heintze C, Gensichen J, Beutel A, Wascher C, Friemel CM, Kosilek RP, Sanftenberg L, Schmidt KF, Gehrke-Beck S. Acceptance of a general practitioner-led narrative exposure intervention on post-traumatic stress symptoms after intensive care: a qualitative interview study with providers. BMJ Open. 2026 Aug 12;16(8):e111473. doi: 10.1136/bmjopen-2025-111473.

    PubMed 42586728

  • Kosilek RP, Schroder N, Sanftenberg L, Jung-Sievers C, Lindemann D, Beutel A, Schmidt K, Brettschneider C, Konig HH, Elbert T, Gensichen J. Effects of a brief primary care intervention for post-traumatic stress disorder symptoms after critical illness on health-related quality of life - A secondary analysis of the PICTURE randomised controlled trial. Eur J Gen Pract. 2026 Dec;32(1):2702686. doi: 10.1080/13814788.2026.2702686. Epub 2026 Jul 21.

    PubMed 42480006

  • 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.

    PubMed 40335079

  • 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.

    PubMed 39815198

  • 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.

    PubMed 30201053

Questions about this trial

What is this clinical trial studying?

A study testing "Narrative Exposure Therapy"-oriented intervention and improved treatment as usual (iTAU) in people with Stress Disorders, Post-Traumatic, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Posttraumatic Stress (time frame: from baseline data collection to 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315390, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.

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