Trial document




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  DRKS00006095

Trial Description

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Title

Experimental studies of psychosocial and neural sequelae of childhood interpersonal violence in adults

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Trial Acronym

EURELEASE

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URL of the Trial

http://www.traumatherapie-verbund.de

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Brief Summary in Lay Language

Having intrusive images (recollection), dissociative symptoms (insubstantial experiences) and reduced pain sensitivity are among others hallmark symptoms of a posttraumatic stress disorder. The current study aims to investigate, whether such symptoms also hold true for women who have experienced childhood sexual or physical abuse before the age of 18 but did not develop a posttraumatic stress disorder as a consequence. In this study the attention is focused on the investigation and the comparison of patients with a posttraumatic stress disorder, healthy women with the above mentioned experiences as well as healthy women without any traumatic experiences with regards to the characteristics of such symptoms. Within the frame of an experimental investigation (20 minutes) the participants are asked to fulfill mental math tasks while being distracted. For three times, an additional pain stimuli with a temperature of 46°C will be applied for a duration of 30 seconds. The experimental study will take place a second time with the arm 1 (PTSD patients) after receiving one year of trauma therapy to examine whether and to which extent the above mentioned symptoms have changed over time.
In addition to that experimental investigation, a diagnostic interview will be conducted (round about 90 minutes) and questionnaires will be handed out to assess the participants’ physical and mental health together with their quality of life.

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Brief Summary in Scientific Language

Having intrusive images, dissociative symptoms and reduced pain sensitivity are among others hallmark symptoms of a posttraumatic stress disorder (Geuze et al., 2007; Michael et al., 2004; Bremner et al.,1992; Pitman et al., 1990). The current study aims to investigate, whether such symptoms also hold true for so called trauma controls: women who have experienced childhood sexual or physical abuse before the age of 18 but did not develop a posttraumatic stress disorder as a consequence. In this study the attention is focused on the investigation and the comparison of patients with a posttraumatic stress disorder, trauma controls with the above mentioned experiences as well as healthy controls without any traumatic experiences with regards to their psychopathology. Within the frame of an experimental investigation (20 minutes) the psychosocial and neural sequelae of childhood interpersonal violence in adults will be examined. Participants are asked to fulfill mental math tasks while being distracted. For three times, an additional pain stimuli with a temperature of 46°C will be applied for a duration of 30 seconds. In addition to that experimental investigation, a diagnostic interview will be conducted (round about 90 minutes) and questionnaires will be handed out to assess the participants’ physical and mental health together with their quality of life.

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Organizational Data

  •   DRKS00006095
  •   2014/05/21
  •   [---]*
  •   yes
  •   Approved
  •   2013-635N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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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

  •   80 patients with posttraumatic stress disorder will be examined and compared with regards to their psychopathology (especially concerning their pain sensitivity, their tenedency to dissociate and their intrusive experiences). This examination will include a diagnostical interview (2 h), a battery of questionnaires concerning quality of life, sexuality, sleep, dissociation, intrusive experiences ans resilience) as well as an experimental investigation (fulfill mental math tasks while being distracted with a 3 times application of a pain stimulus at 46 °C for 30 seconds ). This experimental investigation will take place a second time with this particular sample. The aim of the second investigation is the investigation of change in symptoms like pain sensitivity, dissocation and intrusive experiences. This arm is part of another DRKS registered study (DRKS00005578, amendment 3.4.2015, accepted 24.4.2015).
  •   30 helathy but traumatized control subjects (intervention as arm1, but only once)
  •   30 healthy control subjects (intervention as arm1, but only once)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Experimental investigation:unique investigation of all participants within the frame of the above mentioned study and second investigation for arm 1 (primarily with regards to their tendency to dissociate, intrusive experiences and pain sensitivity). The time frame of the investigations is set until January 2016.

The time frame of the second investigation of arm 1 starts in July 2016 and is set until July 2017.

Questionnaires: unique filling in of questionnaires before participating in the experimentalinvestigation as part of the diagnostical interview in the following fields:

Quality of Life:

-WHOQOL-BREF ( Skevington et al., 2003)
- SF-36 (Ware& Sherbourne, 1992)
-EQ-5D (EuroQol-Group, 1987)

tendency to dissociate:
-FDS (Spitzer et al., 2004)

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Secondary Outcome

Questionnaires:

depressive resentment:
- BDI-II (Beck et al., 1961))


physical and mental health well-being during the last 7 days:
- BSI (Spitzer et al., 2008)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/06/15
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Group 1: female; aged between 18 and 65 years; suffering from a posttraumatisstress disorder adter chidhood sexual or physical abuse before the age of 18 (sexual or physical abuse must be the index trauma); at least 3 criteria of a Borderline Personality Disorder (including criterion 6: affective instability).
Group 2: female, aged between 18 and 65 years; childhood sexual or physical abuse before the age of 18.
Group 3: female; aged between 18 and 65 years.

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Exclusion Criteria

Group 1: diagnosis of schizophrenia or bipolar I disorder;mental retardation; severe psychopathology which needs to be treated immediately (e.g. BMI < 16); suicide attemt within the last 2 months.
Group 2: diagnoses of Axis-I disorder; diagnosis of Borderline Personality Disorder; any taking of psychotropic drugs.
Group 3: diagnoses of Axis-I disorder; diagnosis of Borderline Personality Disorder; any taking of psychotropic drugs; any traumatic experience; any psychotherapeutic experience

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Addresses

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    • Zentralinstitut für Seelische Gesundheit Klinik für Psychosomatik und Psychotherapeutische Medizin
    • Mr.  Prof. Dr. med.  Martin  Bohus 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische GesundheitKlinik für Psychosomatik und Psychotheraepeutische Medizin
    • Ms.  Sophie  Rausch 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Psychosomatik und Psychotherapeutische Medizin
    • Ms.  Sophie  Rausch 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr.  Martin  Bohus 
    • J5
    • 68159  Mannheim
    • Germany
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    •   [---]*
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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.