PTSD After ICU Survival - Caring for Patients With Traumatic Stress Sequelae Following Intensive Medical Care
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): "Narrative Exposure Therapy"-oriented intervention; improved treatment as usual (iTAU)
Intervention type(s): Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multi-center, observer-blinded, randomized, controlled trial with complex psychological intervention
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-traumatic stress, primary health care, stress disorder