Trial document




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  DRKS00011075

Trial Description

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Title

Catastrophic misinterpretation in patients with panic disorder and patients with other anxiety disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The interpretation of bodily sensations (e.g., heartbeat, breathing) as sign of an impending catastrophe (e.g., heart attack) plays a central role in panic disorder. Research so far has not yet sufficiently answered the question if the catastrophic misinterpretation of bodily sensations is a distinctive characteristic of panic disorder or if it also occurs in other anxiety disorders. The present study aims at gathering further evidence concerning this question.
An experiment will investigate whether patients with panic disorder and patients with other anxiety disorders differ in the catastrophic misinterpretation of bodily sensations and other events. The experimental manipulation is supposed to activate relevant harm-related cognitive schemata in patients with panic disorder.
In a subsequent study, the patients with panic disorder have a questionnaire installed on their smartphones that they are to fill out after the occurrence of panic attacks in their daily lives over a period of two weeks. The questionnaire is a mobile version of the questionnaire used in the experiment. The study aims at replicating the results from the experiment with another methodology.

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Brief Summary in Scientific Language

An experiment with randomized allocation will investigate differences in the catastrophic misinterpretation of panic-relevant bodily sensations and other ambiguous external events between patients with panic disorder and patients with other anxiety disorders (specific phobia, generalized anxiety disorder, and social anxiety disorder). The experimental manipulation is designed to induce unspecific physiological arousal to activate relevant cognitive schemata in the patients with panic disorder.
In a subsequent study, the catastrophic misinterpretation of bodily sensations will be measured after the occurrence of panic attacks in the daily life of patients using an EMA approach. This multi-method approach aims at replicating the results of the experiment with an increased ecological validity.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011075
  •   2016/11/08
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  •   yes
  •   Approved
  •   415/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F40.1 -  Social phobias
  •   F40.2 -  Specific (isolated) phobias
  •   F41.1 -  Generalized anxiety disorder
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Interventions/Observational Groups

  •   Experimental condition: Induction of unspecific physiological arousal via an "exciting" film clip; (1) patients with panic disorder, (2) patients with another anxiety disorder, and (3) healthy controls.
  •   Control condition: No induction of physiological arousal (presentation of "neutral" film clip); (1) patients with panic disorder, (2) patients with another anxiety disorder. and (3) healthy controls.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cognitive processing of ambiguous stimuli (self-report using a questionnaire)

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Secondary Outcome

Strength of belief in own interpretations (self-report using a questionnaire), psychophysiological arousal (skin conductance level)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/04/04
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

primary diagnosis panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia in accordance with ICD-10/DSM-5; control condition: no diagnosis according to ICD-10/DSM-5 (acute and lifetime)

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Exclusion Criteria

Panic disorder: cardiac or respiratory disease in medical history; other anxiety disorders: panic attacks in case history (except if only in phobic situations); control condition: diagnosis according to ICD-10/DSM-5 (acute and lifetime)

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Addresses

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    • Klinische Psychologie und Psychotherapie, Institut für Psychologie, Universität Freiburg
    • Ms.  Prof. Dr.  Brunna  Tuschen-Caffier 
    • Engelbergerstr. 4
    • 79106  Freiburg
    • Germany
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    • Klinische Psychologie und Psychotherapie, Institut für Psychologie, Universität Freiburg
    • Mr.  M.Sc.  Barnabas  Ohst 
    • Engelbergerstr. 41
    • 79106  Freiburg
    • Germany
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    • Klinische Psychologie und Psychotherapie, Institut für Psychologie, Universität Freiburg
    • Mr.  M.Sc.  Barnabas  Ohst 
    • Engelbergerstr. 41
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinische Psychologie und PsychotherapieInstitut für PsychologieUniversität Freiburg
    • Ms.  Prof. Dr.  Brunna  Tuschen-Caffier 
    • Engelbergerstr. 4
    • 79106  Freiburg
    • Germany
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    • Wissenschaftliche Gesellschaft Freiburg, Haus "Zur Lieben Hand"
    • Löwenstr. 16
    • 79098  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/27
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Trial Publications, Results and other Documents

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