Trial document




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  DRKS00017749

Trial Description

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Title

Self-Management and PTSD – Assessing Usability and Applicability of CoachPTBS as well as HCC over time

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Trial Acronym

Self Management with PTSD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

How do people affected by post-traumatic stress disorder (PTSD) cope with their symptoms outside of therapy? What are capabilities of digital tools, such as CoachPTBS?

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Brief Summary in Scientific Language

- Survey Usability and Applicability of Apps for mobile devices (Smartphones, Tablet PC)
- Analysis of Association of PTSD Symptoms and Coping Strategies with biological markers (intermediate integrated levels of cortisol and endocannabinoids from hair samples)

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Organizational Data

  •   DRKS00017749
  •   2019/11/07
  •   [---]*
  •   yes
  •   Approved
  •   EK 282062019, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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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

  •   [App Group]
    t0: before using the App (questionnaires, in situ)
    - use app for 2 weeks –
    t1: after two weeks use of app (online questionnaires)
    - use app for 2 weeks –
    t2: after four weeks use of app (online questionnaires)
    t3: six weeks after initial use (hair cortisol, debriefing, in situ)
  •   [Control Group]
    t0: before study begins (questionnaires, in situ)
    t1: two weeks after study begin (online questionnaires)
    t2: four weeks after study begin (online questionnaires)
    t3: six weeks after study begin (hair cortisol, debriefing, in situ)
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Characteristics

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

H0: no significant difference regarding complaints (PCL-5, PTCI, FDS, PHQ at t0 vs. t1/t2/t4) and quality of life (SF-8, PANAS, DERS at t0 vs. t1/t2/t4) PTSD patients who use the app as compared to those who do not (n = 52 per group).

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Secondary Outcome

H0: perceived efficiency of coping strategies (BriefCOPE at t0/t2) and self-rated symptom load do not correlate with biological stress markers (hair cortisol, endocannabinoids) from hair samples (n = 52 per group).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/11/11
  •   104
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

German Language Skills at least level B1
A-Criterion PTSD (ICD-10)
Must own Smartphone (App-Group)
Hair at least 1cm

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Exclusion Criteria

No sign of balding
Female: not currently pregnant or nursing
Currently no Cortison-based medication within the last six weeks
No somatic diseases that interfere with the study / parameters
No more than 15 cigarettes per day
Not currently working in shifts
No current jet lag

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Addresses

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    • Klinik und Poliklinik für Psychotherapie und Psychosomatik, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Ms.  Dr.  Julia  Schellong 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinik und Poliklinik für Psychotherapie und Psychosomatik, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Ms.  Dr.  Julia  Schellong 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Psychotherapie und Psychosomatik, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Ms.  Dr.  Julia  Schellong 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Psychotherapie und Psychosomatik
    • Ms.  Dr.  Julia  Schellong 
    • Fetscherstraße 74
    • 01307  Dresden
    • 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.