Trial document





This trial has been registered retrospectively.
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  DRKS00018818

Trial Description

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Title

SmartPTSD: Ambulatory assessment of symptom fluctuations and coping strategies within the context of posttraumatic stress disorder

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Trial Acronym

SmartPTSD

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URL of the Trial

http://n.a.

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Brief Summary in Lay Language

Posttraumatic stress disorder (PTSD) is among the psychological conditions which are relatively well-researched and treatable. However, there are still many open questions, which majorly concern the patients' everyday lives outside psychotherapy. New technologies, such as smartphones make it possible to collect data outside laboratories or therapy facilities in order to increase knowledge about PTSD and thus treat it more effectively. We are particularly interested in the complaints that subjects with PTSD experience as part of their everyday life and the way in which they deal with them. Furthermore, we want to find out how these factors are related to biological stress markers (e.g. the "stress hormone" cortisol as well as stress-associated endocannabinoids).
For the study, PTSD subjects and healthy control subjects will be recruited.
In this study, the participants will receive a short questionnaire on their smartphone once a day in the evening over a period of four weeks, which will concern their symptomatology during the day (PTSD+) or their negative emotions during the day (KG) as well as their ways of dealing with them. Two days a week they will additionally receive five short questionnaires spread over the day. In order to compare the quality of such data collection in everyday life with that of classical surveys, the participants will be invited to an on-site examination at one point before and one point after the outpatient data collection phase, during which they will complete questionnaires. In addition, three small hair samples will be taken at each of these assessments to examine biological stress markers. In addition, the participants take part in two online surveys. In order to further investigate the effects of such close-meshed data collection on the survey contents, a third group of test persons with PTSD (PTSD-) will only participate in the on-site and online surveys.

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Brief Summary in Scientific Language

It is well known from cross-sectional studies that individual coping strategies significantly influence the pathogenesis of posttraumatic stress disorder (PTSD). Equally undisputed is the role of biological processes, e.g., of the so-called ‘stress hormone’ cortisol for the trajectory of PTSD. Ecological momentary assessment (EMA), the repeated collection of self-reported momentary states via smartphones, is ideal for shedding light upon symptom fluctuations and coping strategies. EMA may also constitute a promising approach to provide closer associations to biomarkers than retrospective self-report. However, these processes have never been examined in a combined, longitudinal fashion.
The aim of the current study is to assess symptom fluctuations, coping strategies and long-term endocrine correlates of PTSD by a longitudinal, multimodal approach, combining traditional, online and EMA self-report with hair cortisol data. To this end, PTSD patients (PTSD+) will answer short smartphone queries on symptoms and coping strategies once to six times a day over a period of four weeks. In order to compare data regarding EMA and traditional retrospective surveys, the participants will additionally complete self-report inventories on symptoms and coping during an appointment before and after the EMA phase at the laboratory (t0, t3), as well as during two online surveys (t1, t2). In order to investigate the associations of both retrospective and outpatient data with stress-associated biomarkers, hair samples are taken at t0 and t3 to determine steroid and endocannabinoid profiles.
For a comparison of coping strategies of PTSD and healthy control subjects, healthy control subjects (KG) will be recruited who will go through the same study procedure with a focus on negative emotions instead of PTSD symptoms. To further investigate the effects of the EMA study on retrospective symptom assessment, a group of PTSD subjects (PTSD-) will be recruited who exclusively undergo t0 - t3 without the EMA phase.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Raw data + possibly statistical syntax
Data available on request
Data shared on, i.e., OSF
After the end of the study

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Organizational Data

  •   DRKS00018818
  •   2019/12/18
  •   [---]*
  •   yes
  •   Approved
  •   EK 335082017, 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

  •   PTSD+

    t0: Questionnaires, hair sampling: in situ
    - EMA (Ecological momentary assessment) PTSD symptomatology & coping 2 weeks -
    t1: (t0 + two weeks) Questionnaires: online
    - EMA PTBS-Symptomatik & Coping 2 weeks -
    t2: (t0 + four weeks) Questionnaires: online
    t3: (t0 + six weeks) Questionnaires, hair sampling, study completion: in situ
  •   PTSD-

    t0: Questionnaires, hair sampling: in situ
    t1: (t0 + two weeks) Questionnaires: online
    t2: (t0 + four weeks) Questionnaires: online
    t3: (t0 + six weeks) Questionnaires, hair sampling, study completion: in situ
  •   CG

    t0: Questionnaires, hair sampling: in situ
    - EMA negative emotions & coping 2 weeks -
    t1: (t0 + two weeks) Questionnaires: online
    - EMA negative emotions & Coping 2 weeks -
    t2: (t0 + four weeks) Questionnaires: online
    t3: (t0 + six weeks) Questionnaires, hair sampling, study completion: in situ
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

I. Interindividual fluctuations: There are considerable interindividual variations between PTSD participants regarding symptom fluctuations and applied coping strategies (EMA data).

II. Intraindividual fluctuations: Next to interindividual variations, there also are substantial intraindividual variations, e.g., patterns of symptom increase and decrease, variety of applied coping strategies, and effectivity of those strategies (EMA data).

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Secondary Outcome

III. Associations with biomarkers: For participants with proximal traumatization, hair cortisol concentration (HCC) is expected to be positively correlated to symptom severity and negatively correlated to coping efficacy, and vice-versa for participants with more distal traumatization (EMA; questionnaires t0, t1, t2, t3; hair sampling t0 and t3).

IV. Associations with psychological variables: Individual coping efficacy and variability are inversely associated with symptom severity and posttraumatic cognitions and positively associated with individual abilities of emotion regulation (EMA; hair sampling t0 and t3).

V. Psychoendocrine Covariance: The associations of biomarkers with EMA self-report are closer than those of biomarkers with retrospective self-report (EMA; questionnaires t0, t1, t2, t3; hair sampling t0 and t3).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/08/17
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

PTSD+:
PTSD, between 18-60 years old, hair length min. 1 cm, smartphone with Android operating system, free from chronic diseases, free from other severe psychological conditions (e.g. psychosis, bipolar disorder, alcohol, medication or drug addiction), no hydrocortisone-containing medicaments/creams have been taken or used within the last six weeks (e.g. asthma spray), for women: Not pregnant or breastfeeding, for smokers: No more than 15 cigarettes per day;

PTSD-: Same, but no smartphone necessary

CG: Same, but no PTSD prevalent

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Exclusion Criteria

see above

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Addresses

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    • Lehrstuhl für Biopsychologie, Technische Universität Dresden
    • Ms.  M. Sc.  Lena  Schindler 
    • Zellescher Weg 19
    • 01069  Dresden
    • Germany
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    • Klinik und Poliklinik für Psychotherapie und Psychosomatik, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden
    • Dresden
    • Germany
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    • Lehrstuhl für Biopsychologie, Technische Universität Dresden
    • Ms.  M. Sc.  Lena  Schindler 
    • Zellescher Weg 19
    • 01069  Dresden
    • Germany
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    • Lehrstuhl für Biopsychologie, Technische Universität Dresden
    • Ms.  M. Sc.  Lena  Schindler 
    • Zellescher Weg 19
    • 01069  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Lehrstuhl für Biopsychologie, Technische Universität Dresden
    • Zellescher Weg 19
    • 01069  Dresden
    • Germany
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    • Studienstiftung des deutschen Volkes
    • Ahrstraße 41
    • 53175  Bonn
    • Germany
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Status

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