Trial document




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  DRKS00016931

Trial Description

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Title

Internet-based therapy for physicians with post-traumatic stress

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Trial Acronym

IPSA Study

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URL of the Trial

http://www.belastung-im-arztberuf.de

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Brief Summary in Lay Language

Physicians have an increased risk for experiencing traumatic events as they are daily confronted with suffering and death. After experiencing a traumatic event, physicians might develop post-traumatic stress or a post-traumatic stress disorder. Post-traumatic stress disorders are characterized by intrusions (unwanted upsetting re-experiencing of the traumatic event), avoidance, negative alterations in cognitions and mood, and alterations in arousal and reactivity (e.g., irritabiloty or aggression). Post-traumatic stress in physicians is associated with a high burden (depression, heightened suicidality) and job-related risks (impaired functionality). To date, no sepcific intervention exists for this target group. The aim of the study is the evaluation of an internet-based therapy for physicians with post-traumatic stress. It is assumed that post-traumatic stress and other psychiatric problems will be reduced due to the intervention.

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Brief Summary in Scientific Language

The aim is the evaluation of an internet-based cognitive-behavioral intervention for physicians suffering post-traumatic stress after experiencing a traumatic event during their work. Further, factors influencing the effectiveness of the intervention will be investigated. It is hypothesized that post-traumatic stress and other psychiatric problems (e.g., depression, anxiety, and somatization) will be decreased and quality of life as well as physical and psychological functionality will be increased after the intervention. A randomized-controlled design with a wait list control group will be used to evaluate the intervention.

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Organizational Data

  •   DRKS00016931
  •   2019/05/13
  •   [---]*
  •   yes
  •   Approved
  •   146/19-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1229-7326 
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Health Condition or Problem studied

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

  •   Intervention group: The intervention group receives the internet-based intervention immediatly after randomization. The at least 5 weeks lasting intervention is composed of 10 structured writing assignments (45 minutes each), divided into three treatment phases: self-confrontation, cognitive restructuring and social sharing (reflection on the therapeutic process, changes in life, and future perspectives). After each assignment, participants receive feedback and the next writing instruction.
  •   Wait list control group: This group receives the intervention 7 weeks after randomization.
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Characteristics

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

Extent of post-traumatic stress, measured by the German version of the PTSD checklist for DSM-5 (PCL-5; Ehring, Knaevelsrud, Krüger, & Schäfer, 2014). Measurments before the intervention, 7 weeks after starting the intervention and p.r.n. after the intervention (or after 7 weeks of waiting) as well as 3, 6, and 12 months after the intervention.

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Secondary Outcome

Depression (PHQ-9), anxiety (GAD-7), somatization (PHQ-15), Burnout (MBI), prescription drug abuse (KFM), alcohol abuse (CAGE, ICD-10 questions), illegal drug abuse (SDS), sleep quality (PSQI), post-traumatic growth (PGI), psychological and physical functionality (SF-12). Measurments before and after the intervention (or after 7 weeks of waiting) as well as 3, 6, and 12 months after the intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2019/09/01
  •   102
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Physicians. After a traumatic event at work, post-traumatic stress is experienced for at least one month (i.e., meeting at least 2 of the DSM-5 Criteria B to E). Sufficient German language skills. Internet access. Informed consent.

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Exclusion Criteria

Severe depression; acute suicidality; psychosis; dissociative tendency; substance abuse; current psychotherapy; change of psychopharmacological treatment within the past 6 weeks; pregnancy; breastfeeding; cognitive or physical impairment that limits participation.

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Addresses

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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig
    • Ms.  Prof. Dr. med.  Anette  Kersing 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig
    • Ms.  Prof. Dr. med.  Anette  Kersting 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig
    • Ms.  Prof. Dr.  Anette  Kersting 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Roland Ernst Stiftung für Gesundheitswesen
    • Naumannstr. 8
    • 01309  Dresden
    • Germany
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    • Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Leipzig
    • Ms.  Prof. Dr. med.  Anette  Kersting 
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.