Trial document




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  DRKS00017664

Trial Description

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Title

Objective Markers of Posttraumatic Dissociation – Assessment of Experimentally Induced Dissociation

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Trial Acronym

ObID

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URL of the Trial

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Brief Summary in Lay Language

Traumatized individuals can suffer consequences long after a traumatic experience has occurred (e.g. in form of a trauma-related disorder). Those suffering from chronic trauma-related disorders may report alterations in their perception and sensation and may report that their world ‘can only be seen through a fog’ or that their own body ‘feels foreign’ when reminded of or thinking of the traumatic event. These symptoms are typically assessed via self-report alone, yet their presence has been associated with measurable physiological changes and differential treatment outcomes.

If trauma-related triggers can provoke alterations in perception and sensation, they can also provoke bodily reactions. To date, psychiatry lacks consensus on valid physiological markers, which can be used to quantify the severity of these symptoms. Some potential markers include electrophysiological cardiac activity, muscular output, body sway, pain responsivity, and smell perception. Electrophysiological cardiac activity can be altered by the stress response, a response, which is mediated by the autonomic nervous system (ANS). The ANS is involved in involuntary regulation of our organs and, thus, ANS changes reflect an unconscious adaption to our environment. Muscular output via electromyography and the degree of natural body sway movements provides insight into a patient’s level of tension in various locations of the body, while pain and smell perception can be employed to elucidate changes in sensory processes.
To identify these markers, we want to invoke the ‘foggy’ symptoms in traumatized patients at a specialized inpatient treatment center and then assess the occurrence and the intensity of the aforementioned markers in these patients. With this study, we hope to determine, whether a trauma script can induce this ‘foggy’ sensation, and whether the resultant physiological changes are, in fact, correlated with this mental fog. These data will provide insight into physiological markers, which may be used by clinicians to aid in diagnosis by providing clear, quantifiable insight into the intensity of this mental fog.

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Brief Summary in Scientific Language

Dissociation is a psychological phenomenon, defined in the DSM-5 as a disruption, interruption, and/or discontinuity of the normal, subjective integration of behavior, identity, consciousness, emotion, perception, body representation, and motor control. Dissociation may occur to a pathological degree within the scope of mental disease. Recurring posttraumatic dissociation, long after the traumatic event occurs, is a known phenomenon in patients suffering from chronic posttraumatic stress disorder (PTSD). These patients report experiences of depersonalization (the feeling that one’s body doesn’t belong to oneself or out-of-body experiences), and de-realization (the feeling that the surroundings are unreal). Such negative symptoms attenuate the sensory and emotional self-experience of afflicted individuals.
The majority of published research regarding posttraumatic dissociation classifies dissociative states via assessment of a patient’s subjective introspection, yet the core features of dissociative symptomology can compromise introspection itself. To date, research has failed to identify objective psychophysiological markers, which quantify the severity of posttraumatic dissociation. We aim to investigate the relationship between posttraumatic dissociation and the presence of various physiological changes, including electrophysiological cardiac activity, muscular output, body sway, pain responsivity, and smell perception.

When patients are asked about their dissociative experiences, they might mention symptoms, which refer to changes in cardiac electrophysiology. That is in line with laboratory studies, which report a declined heart rate during dissociation. Further support for a negative correlation between the intensity of dissociation and heart rate is given by analogue studies on healthy subjects. However, there is limited empirical literature assessing objective changes in heart rate in PTSD patients specifically. Electrophysiological cardiac markers including heart rate and heart rate variability are easily assessable via electrocardiogram (ECG). The muscular response reflects a patient’s level of electrical activity in various locations of the body and can be measured non-invasively with electromyography (EMG). Little data has been collected on application of EMG to the extremities affected by body sway (e.g. lower legs) and not affected by body sway (e.g. distal forearm). Body sway is a marker of involuntary self-regulation of changes in balance. Recent advancements in sports and medical technology allow for the collection of data on a patient’s body sway while standing on a force plate, which can indicate a patient’s extent of dissociation. Pain responsivity provides insight on the extent of patients’ dissociation and perception of themselves by assessing their ability to recognize and differentiate painful stimuli. Literature suggests that the intensity of dissociation is correlated with the pain threshold, but research on PTSD patients is limited. The ability to smell may also be altered in patients who undergo posttraumatic dissociation, since olfaction also represents sensory perception.

The main target of this study is to examine physiological reactions following experiment-induced dissociations in PTSD patients. Specifically, we will assess dissociation after neutral and trauma scripts. To clarify if these physiological reactions are specific for dissociative symptoms in these patients we compare them to a group of non-dissociative PTSD patients. To investigate this issue these hypotheses will be tested:

Hypothesis – conditions in the symptom provocation paradigm (within-subjects):
H0: Participants do not show significantly different values directly after the neutral, autobiographical script than directly after the symptom provocation script with regard to their olfactory threshold, motor activity, muscular tension, pain sensitivity, and electrophysiological cardiac activity.
H1 (expected outcome): Participants show significantly different values directly after the neutral, autobiographical script than directly after the symptom provocation script with regard to their olfactory threshold, motor activity, muscular tension, pain sensitivity, and electrophysiological cardiac activity.

Hypothesis – association with subjective experience:
H0: There is no significant correlation between the extent of reported acute dissociation during the symptom provocation script and changes in olfactory threshold, motor activity, muscular tension, pain sensitivity, and electrophysiological cardiac activity from neutral to trauma script.
H1 (expected outcome): There is a significant correlation between the extent of reported acute dissociation during the symptom provocation script and changes in olfactory threshold, motor activity, muscular tension, pain sensitivity, and electrophysiological cardiac activity from neutral to trauma script.

Hypotheses regarding group differences in symptom provocation paradigm (between-subjects):

Neutral script – undirected hypothesis:
H0 (expected outcome): The two groups (PTSD patients with and without dissociative experiences) do not differ significantly immediately after exposure to a neutral autobiographical script with respect to their olfactory threshold, motor activity, muscular tension, pain sensitivity, and electrophysiological cardiac activity.
H1: The two groups differ significantly immediately after exposure to a neutral autobiographical script with respect to their olfactory threshold, motor activity, muscular tension, pain sensitivity, and electrophysiological cardiac activity.

Trauma script – directed hypothesis
H0: The two groups (PTSD patients with and without dissociative experiences) do not differ significantly immediately after exposure to a symptom provocation script with respect to their olfactory threshold, motor activity, pain sensitivity, and electrophysiological cardiac activity.
H1 (expected outcome): Dissociative PTSD patients show a significantly higher olfactory threshold, decreased motor activity, decreased pain sensitivity, lower heart rate and higher heart rate variability compared to non-dissociative PTSD patients immediately after exposure to a symptom provocation script.

Trauma script – undirected hypothesis
H0: The two groups (PTSD patients with and without dissociative experiences) do not differ significantly immediately after exposure to a symptom provocation script with respect to their muscular tension.
H1 (expected outcome): The two groups differ significantly immediately after exposure to a symptom provocation script with respect to their muscular tension.


After obtaining informed consent of the study participants, psychopathological assessments –
complementary to our clinical routine diagnostics – are conducted. According to the script-driven imagery paradigm, a trauma-relevant script will be drafted during these assessments, as well as a neutral autobiographical script (control condition)

Participating in-patients who meet inclusion criteria will be selected from the specialized trauma-clinic for a two-hour long physiological assessment. This assessment will begin with threshold testing of each physiological parameter, followed by three repetitions of a neutral script and three repetitions of a trauma script, according to the script-driven-imagery paradigm. Each script will be played for 30 seconds, followed by 30 seconds during which the patient is instructed to actively engage in visual imagery regarding the content of the script. During each script, measures of ECG, EMG and body sway will be taken. Immediately after each script, measures of pain perception and olfactory threshold will be taken. Physiological responses will be assessed as follows: electrophysiological cardiac activity with an ECG attached to the patient’s chest, muscular activity with EMG electrodes attached to the patient’s muscles (large leg muscle involved in compensating stability movements, uninvolved arm muscle as a control), body sway with a force plate, pain responsivity with a mechanical pain response test, and smell threshold with an olfactory threshold test. Following testing, patients will be assessed on their level of response to the trauma script with a Response to Script Driven Imagery (RSDI) Scale.

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Organizational Data

  •   DRKS00017664
  •   2019/09/02
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  •   yes
  •   Approved
  •   EK229062018, 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

  •   We provoke dissociation in patients via script-driven-imagery, while we assess ECG, EMG, and body sway. After the script, we assess response to painful and olfactory stimuli as well as psychological response via the RSDI scale.
  •   As control condition we use a neutral autobiographical script on the same patients, while we assess ECG, EMG, and body sway. After the script, we assess response to painful and olfactory stimuli as well as psychological response via the RSDI scale.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Changes in heart rate and heart rate variability, muscular activity, body sway, pain responsivity, and smell perception under induced dissociation.

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Secondary Outcome

Physiological response to intrusive symptoms after script-driven-imagery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/09/15
  •   72
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Informed consent; Inpatient stay in hospital; Good German language skills; Diagnosis of a posttraumatic stress disorder (PTSD)

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Exclusion Criteria

− Severe head injuries as well as neurological disorders
− Diagnosis of comorbid: Organic, including symptomatic, mental disorders (F00-F09); Mental
and behavioural disorders due to psychoactive substance use (F10-F19); Schizophrenia,
schizotypal and delusional disorders (F20-F29); Emotionally
unstable personality disorder – borderline (F60.31)
− Beta blocker therapy within the last 4 weeks

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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.  Jun. Prof. Dr. habil.  Ilona  Croy 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Klinik und Poliklinik für Psychotherapie und Psychosomatik Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Ms.  M. Sc.  Sarah  Beutler 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Faculteit Gedrags- & Maatschappijwetenschappen Experimentele Psychopathologie — Basiseenheid Klin. Psych. & Exp. Psychopathologie Rijksuniversiteit Groningen
    • Ms.  Dr.  Judith  Daniels 
    • Grote Kruisstraat 2
    • 9713 TS  Groningen
    • Netherlands
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    • Klinik und Poliklinik für Psychotherapie und Psychosomatik Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Ms.  M. Sc.  Sarah  Beutler 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Heinrich-Böll-Stiftung e.V.
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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