Trial document




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  DRKS00010676

Trial Description

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Title

Reducing posttraumatic stress after severe sepsis in patients and their spouses

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Trial Acronym

REPAIR

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URL of the Trial

http://www.cscc.uniklinikum-jena.de/Forschung/Rehabilitation+und+langfristige+Folgen+der+Sepsis+%7C+Repair/Repair.html

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Brief Summary in Lay Language

As a consequence of severe sepsis and intensive care, considerable proportions of patients but also of their spouses develop a posttraumatic stress disorder (PTSD). Internet-based writing therapy has proven to be an effective treatment option for PTSD and fits the specific needs of sepsis patients. However, there are barely any therapeutic approaches that include spouses in addition to the patients into the treatment.
Aim of the study is to examine the efficacy and applicability of an internet-based treatment for posttraumatic stress disorder in patients after severe sepsis and their spouses.
Participants will be assigned randomly either to a treatment or a waitlist control group.
The treatment group receives an internet-based writing therapy for PTSD that will be guided by a therapist and comprises two 50-minute written assignments per week over a 5-week period (10 assignments in total). After completing the assignments, the participants receive individual response and further instructions from the therapist within one workday. Participants of the waitlist group will receive treatment after the waiting period (after about 5 weeks).

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Brief Summary in Scientific Language

Considering the high prevalence of PTSD in patients after severe sepsis and their spouses as well as the fact that PTSD is an undertreated problem, there is a need for specific treatment approaches.
Internet-based writing therapy has been proven to be as efficacious as face-to-face PTSD treatment and can be easily attended by the patients and/or their spouses from home.
However, there are barely any therapeutic approaches for PTSD including spouses in addition to patients.
Aim of the trial is 1) to investigate the efficacy and applicability of an internet-based intervention for posttraumatic stress disorder in patients after severe sepsis and their spouses, 2) to assess maintenance of possible treatment gains at 3, 6, and 12 months post-treatment, 3) to examine dyadic concordance in treatment effects, i.e. indirect effects of the treatment in the respective partner of the participant of the treatment, and 4) to investigate the influence of dyadic coping on the treatment effects.
Participants will be randomly assigned to one of two conditions, either an intervention group or a waitlist control group. Participants of the intervention group receive an internet-based writing therapy for PTSD that will be guided by a therapist and comprises two 50-minute written assignments per week over a 5-week period (10 assignments in total).
After completing the assignments, the participants receive individual response and further instructions from the therapist within one workday. The waitlist control group serves as control against spontaneous remission and will receive treatment after the waiting period (after about 5 weeks).
We will include adult patients after severe sepsis with intensive care > 5 days or spouses of patients, one or both with clinically relevant posttraumatic stress symptoms, fluent in written German, and having internet access. The trauma has to be associated with intensive care for treatment of sepsis.
We will exclude patients without spouse, patients with acute psychosis, suicidal intentions, using neuroleptics, or undergoing concurrent psychotherapeutic treatment.
Primary endpoint will be symptom severity of posttraumatic stress at the end of treatment (about 5 weeks after randomization). Secondary endpoints will be remission of PTSD, depression, anxiety, somatization, marital satisfaction
health-related quality of life (all mentioned outcomes assessed at the end of treatment, 3, 6, and 12 months post-treatment), and percentage of participants leaving the study early due to any reason.

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Organizational Data

  •   DRKS00010676
  •   2016/06/14
  •   [---]*
  •   yes
  •   Approved
  •   4777-04/16, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
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Interventions/Observational Groups

  •   Therapist-guided, manualized, internet-based therapy for treating posttraumatic stress disorder in patients after severe sepsis and/or their spouses; clients complete two 50-minute written assignments per week over a 5-week period (10 assignments in total)
  •   Waitlist control group
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Symptom severity of posttraumatic stress (about 5 weeks after randomization; measured via the Posttraumatic stress disorder checklist [PCL-5])

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Secondary Outcome

Remission of PTSD (measured via the Clinician-Administered PTSD Scale [CAPS]), depression, anxiety, somatization (measured via the Brief Symptom Inventory-18 [BSI-18]), marital satisfaction (measured via the Relationship Assessment Scale [RAS]),
health-related quality of life (measured via the EQ-5D-5L; all mentioned outcomes assessed at the end of treatment, 3, 6, and 12 months post-treatment), percentage of participants leaving the study early (during treatment phase) due to any reason; assessment of safety: Monitoring of suicidality and behavioral adverse effects

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/04/27
  •   196
  •   Monocenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients after severe sepsis with intensive care > 5 days or spouses of patients with clinically relevant posttraumatic stress symptoms, trauma associated with intensive care for treatment of sepsis, fluent in written German, internet access

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Exclusion Criteria

Patients without spouse, acute psychosis, suicidal intentions, use of neuroleptics, concurrent psychotherapeutic treatment

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Addresses

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    • Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Center for Sepsis Control and Care (CSCC)
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Freie Universität Berlin, Klinische Psychologie und Psychotherapie
    • Ms.  Prof. Dr.  Christine  Knaevelsrud 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Universitätsklinikum Jena, Institut für Psychosoziale Medizin und Psychotherapie
    • Ms.  PD Dr.  Jenny  Rosendahl 
    • Stoystr. 3
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena, Institut für Psychosoziale Medizin und Psychotherapie
    • Ms.  Romina  Gawlytta 
    • Stoystr. 3
    • 07740  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.