Trial document





This trial has been registered retrospectively.
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  DRKS00010827

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 II

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URL of the Trial

http://www.traumatherapie-verbund.de

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Brief Summary in Lay Language

The extension of learned emotional responses to events, which have not been present during the traumatic event is discussed as a relevant mechanism in the development and maintenance of Posttraumatic Stress Disorder (PTSD). In addition, the ability to remember a detailed autobiographical memory seems to be affected. Yet, there are no studies investigating the extension of learned emotional responses experimentally, nor linking this effect to a reduced ability in remembering autobiographical memories in detail in PTSD. The study therefore investigates these processes in a sample of women exposed to interpersonal violence prior to the age of 18 (physical and/or sexual abuse). Herein, individuals who have developed a PTSD are contrasted to participants, which have never developed a mental disorder throughout their life. In addition, both groups are compared to healthy women, who have never been exposed to a traumatic event. In detail, we investigate alterations in associative learning processes and the potential fear transfer to stimuli sharing perceptual similarities. In addition, we assess the ability to recall specific autobiographical memories.
Individuals with a PTSD are participants of the therapy study RELEASE (DRKS00005578). PTSD patients, as well as two healthy control samples with and without traumatic experiences, take also part in the study EURLEASE (DRKS00006095).

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Brief Summary in Scientific Language

The overgeneralization of learned emotional responses to trauma-associated stimuli is discussed as a relevant mechanism in the development and maintenance of Posttraumatic Stress Disorder (PTSD) (Lissek & van Meurs, 2015). In addition, the autobiographical memory seems to be affected: the generation, as well as the recall of autobiographical memories are characterized to be less specific (for review see also Brewin 2007; Moore & Zoellner, 2007; Sumner 2012). Yet, there are no studies investigating overgeneralization experimentally, nor linking overgeneralization to reduced autobiographical memory specificity. The study therefore investigates these processes in a sample of women exposed to interpersonal violence prior to the age of 18 (physical and/or sexual abuse). Herein, individuals who have developed a PTSD are contrasted to participants, which have never developed a mental disorder throughout their life. In addition, both groups are compared to healthy women, who have never been exposed to a traumatic event. In detail, subjects underwent a 2,5h study procedure. Within a first contingency learning task, subjects learn to differentiate between two perceptually distinct stimuli: one stimulus is associated with an electric shock (danger cue), while the other is never followed by an electric shock (safety cue). Subsequently, a generalization transfer test is applied, assessing fear transfer to stimuli creating a continuum of similarity between the danger and safety cue. Primary outcome variables comprise online risk ratings and fear potentiated startle. In addition, we assess autobiographical memory specificity (AMT; Williams & Broadbent).
Individuals with a PTSD are participants of the therapy study RELEASE (DRKS00005578). PTSD patients, as well as two healthy control samples with and without traumatic experiences, take also part in the study EURLEASE (DRKS00006095).

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Organizational Data

  •   DRKS00010827
  •   2016/07/22
  •   [---]*
  •   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 (participants of the studies: RELEASE and EUREALSE) will be examined and compared with regards to their psychopathology (especially concerning their fear conditioning, their tendency to generalize conditioned fear and their autobiographical retrieval style). The study procedure lasts for 2,5h: Within a first contingency learning task, subjects associate one stimulus with an electric shock (danger cue), while a perceptual different stimulus will never be followed by an electric shock (safety cue). Subsequently, a generalization transfer test is applied, assessing fear transfer to stimuli creating a continuum of similarity between the danger and safety cue. To assess autobiographical retrieval style we apply the autobiographical memory test (AMT; Williams & Broadbent).
  •   30 healthy but traumatized control subjects (intervention as arm1). Participants also take part in the EURLEASE study (DRKS00006095).



  •   30 healthy control subjects (intervention as arm1). Participants also take part in the EURLEASE study (DRKS00006095).

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Characteristics

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

Experimental investigation:
One investigation of all participants regarding the above mentioned study. The time frame of the investigations is set until October 2016. In addition, PTSD patients will undergo the experimental study after therapy completion (DRKS00005578) again.
Criteria:
1) Fear Conditioning (ability to discriminate between danger and safety cues): Subjects underwent a classical conditioning paradigm in which one of two stimuli is followed by an aversive event (danger cue), while a second one will be the conditioned safety cue. At the end of the fear acquisition phase, differential responses to the danger and safety cue are indicative for successful fear learning. Primary outcome variables comprise fear potentiated startle and online risk ratings.
2) Extent of learned fear conditioned generalization to similar perceptual cues:
Subjects underwent a generalization testing phase: Both, the conditioned danger and safety cue, as well as eight additional stimuli creating a continuum of similarity between the danger and the safety cue are displayed (generalization stimuli). The extent of fear responding to the generalization stimuli is indicative for fear generalization. The higher fear responses are exhibited in response to less similar generalization stimuli, the stronger is the present fear generalization. Primary outcome variables comprise fear potentiated startle and online risk ratings.
3) Autobiographical memory specificity to positive and negative cue words:
Participants will be exposed to 10 cue words (5 positive, 5 negative). They are instructed to remember a specific memory within a time limit of 2 minutes. A specific memory is characterized by the following information: exact time, place, is not allowed to last longer than a day.

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Secondary Outcome

Questionnaire:
PTSD, as well as trauma controls fill in a generalization – questionnaire after the testing. In addition, PTSD patients will fill in the questionnaire after the second testing post therapy.

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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 Posttraumatic Stress Disorder after childhood 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 Mannheim
    • Mr.  Prof  Martin  Bohus 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Janine  Thome 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Ms.  Janine  Thome 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitut für Seelische Gesundheit Mannheim
    • Mr.  Prof  Martin  Bohus 
    • J5
    • 68159  Mannheim
    • 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.