Trial document





This trial has been registered retrospectively.
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  DRKS00005705

Trial Description

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Title

Real Time Assessment of Intrusive Memories in Patients with Post-traumatic Stress Disorder after Interpersonal Violence

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Trial Acronym

MEMO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Physical and sexual abuse during childhood and adolescence are frequently related to intrusive recollections related to the traumatic event. These recollections are typically assessed in retrospection by questionnaires and interviews. Retrospection is, however, prone to significant bias. As a consequence the frequency and intensity of these symptoms under every day conditions is largely unknown. We will use smartphones to assess the frequency of these intrusive recollections, by which emotions they are accompanied, and to which extent the repeated assessments might influence these variables.

To this end the participants are asked to carry a smartphone during an observation period of 17 days. During that period the participants are asked to answer a variety of questions regarding their recollections and thoughts related to the trauma. The primary goal of the study is to assess the frequency and characteristics of these recollections in patients with PTSD after interpersonal violence in childhood and andolescence.

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Brief Summary in Scientific Language

Interpersonel violence during childhood and adolescence is related to significant psychiatric burden in adulthood. Posttraumatic Stress-Disorder (PTSD) is among the most frequent sequelae of early experiences of interpersonal violenc. Diagnostic criteria of PTSD include intrusive memories related to the trauma. Traditionally, intrusive memories are retrospectively assessed on Likert-scales which aim at capturing the last week or month.

Empirical studies on the frequency and the characteristics of distressing memories are scant. Furthermore, the symptomatology was only retrospectively in these patients. Limitations of retrospective assessments, most notably recall bias and a lack of ecological validity, gave rise to the use of ambulatory assessment. Consequently, we conducted a pilot-study (Priebe, Kleindienst, et al., Psychol Assess., 25(4):1370-6) in female patients with a diagnosis of PTSD after childhood sexual abuse. In this study the patients reported an average of 75 intrusionen and 24 flashbacks. These numbers are substantially higher than the respective numbers as previously reported in the literature. However, these data were assessed in inpatients who were currently treated with a trauma-specific treatment. Furthermore, the findings might have been confounded by the a high frequency of assessement which might have prompted additional recollections related to the trauma.

Our new study follows three major goals: 1) to yield a largely unbiased assessment of the frequency of intrusions and flashbacks in PTSD patients with an interpersonel trauma. 2) to capture the reactivity related to repeated trauma-related assessments. 3) to capture recall bias related to retrospection.

To this end the participants are asked to carry a smartphone during an observation period of 17 days. During that period the participants are asked to answer a variety of questions regarding their recollections and thoughts related to the trauma. By the end of the study the participants fill in several questionnaires to assess pertinent aspects of psychopathology (including symptoms of PTSD and depression), significant events during the study, and their experiences with the use of the smartphone used for ambulatory assessments.

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Organizational Data

  •   DRKS00005705
  •   2014/04/29
  •   [---]*
  •   yes
  •   Approved
  •   2013-536N-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

  •   During this observational study participants are asked to carry a smartphone during an observation period of 17 days. During that period the participants are asked to answer a variety of questions regarding their recollections and thoughts related to the trauma. Both pre and post the assessment period of 17 days participants fill in several questionnaires to assess pertinent aspects of psychopathology.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Frequency of intrusions and flashbacks as assessed by smartphones during an assessment period of 17 days

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Secondary Outcome

a) Vividness of intrusions and flashbacks. Distress related to intrusions and flashbacks (as assessed by specifically programmed items on the smartphone).

b) Emotions related to intrusions and flashbacks (as assessed by specifically programmed items on the smartphone).

c) Reactivity to assessment with electronic diaries (as assessed by experimental variation in the assessments).

d) Recall bias related to retrospective recollections (as assessed by experimental variation in the assessments).

e) Relation of tension and distress on the one hand and the frequency of intrusions and flashbacks on the other hand (both assessed by specifically programmed items on the smartphone).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/07/24
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Informed consent; Diagnosis of a post-traumatic stress disorder (PTSD) after interpersonel violence prior to age of 19. (as assessed with the Clinican-Administered PTSD Scale, CAPS; Blake et al., 1995)

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Exclusion Criteria

Mental retardation;

Lifetime diagnosis of a schizophrenic psychosis ass assessed by the SCID-I (Wittchen, Wunderlich, Gruschwitz, & Zaudig, 1997);

Suicide attempt during the last 4 months;

Acute severe psychopathology necessitating immediate treatment in a different setting;

Current trauma focussed therapy including formal exposure;

Current pharmacotherapy with benzodiazepines.

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Addresses

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    • Klinik für Psychosomatik und Psychotherapeutische Medizin, Zentralinstitut für Seelische Gesundheit
    • Mr. 
    • J 5
    • 68159  Mannheim
    • Germany
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    • Klinik für Psychosomatik und Psychotherapeutische Medizin, Zentralinstitut für Seelische Gesundheit
    • Mr.  Dr.  Nikolaus  Kleindienst 
    • J 5
    • 68159  Mannheim
    • Germany
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    • Klinik für Psychosomatik und Psychotherapeutische Medizin, Zentralinstitut für Seelische Gesundheit
    • Mr.  Dr.  Nikolaus  Kleindienst 
    • J 5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychosomatik und Psychotherapeutische Medizin, Zentralinstitut für Seelische Gesundheit
    • J 5
    • 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.