Trial document




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  DRKS00014012

Trial Description

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Title

Concordance of the foreign- and self-description of aggressive behavioral tendencies in psychotherapeutic outpatients - Increased aggressive behavioral tendencies in depressive patients compared to patients with anxiety disorders, obsessive-compulsive disorders, trauma and stress-related disorders as well as compared to their relatives

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Trial Acronym

FTAV

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is twofold: The priority is to examine the concordance of the foreign-description and the self-description of aggressive behavioral tendencies of outpatients and their relatives. The purpose of this is the examination of the validity of the test inventory of autoaggressive and extraneous aggressive behavioral tendencies. Secondary this study aims to examine the hypothesis that outpatients with unipolar affective disorders report increased aggressive behavioral tendencies both compared to outpatients with anxiety disorders, obsessive-compulsive disorders, and trauma and stress-related disorders as well as compared to their relatives. Therefore, this study will include psychotherapeutic outpatients as well as their relatives.

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Brief Summary in Scientific Language

To enable the investigation of not only active- but also passive-(auto-)aggressive behavioral tendencies, the test inventory of autoaggressive and extraneous aggressive behavioral tendencies was constructed. Passive aggressive behavioral tendencies are willful behavior which inhibits (or could inhibit) the satisfaction of the needs of the own person or another person or willful behavior which inhibits (or could inhibit) that the own person or another person experiences individual positive events.
The priority of this study is to examine the concordance of the foreign-description and the self-description of aggressive behavioral tendencies on the newly developed questionnaire. Therefore both outpatients, as well as their relatives, are included in this examination. Secondary this study aims to examine the hypothesis that outpatients with unipolar affective disorders report increased aggressive behavioral tendencies both compared to outpatients with anxiety disorders, obsessive-compulsive disorders, and trauma and stress-related disorders as well as compared to their relatives. Thereby the focus of our examination are passive-autoaggressive behavioral tendencies.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014012
  •   2018/07/05
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  •   yes
  •   Approved
  •   18-01, Ethikkomission der Fakultät für Empirische Humanwissenschaften und Wirtschaftswissenschaft der Universität des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F42 -  Obsessive-compulsive disorder
  •   F43 -  Reaction to severe stress, and adjustment disorders
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Interventions/Observational Groups

  •   Patients will be subdivided into two groups. Group 1 considers of patients, which are in outpatient's psychotherapy because of a unipolar affective disorder. The remission or persistence of the disorders will be examined with a structured interview. The aggressive behavioral tendencies, depressive symptoms, anxiety symptoms and psychosomatic symptoms of the patients will be surveyed by questionnaires. The patients will be required to describe the aggressive behavioral tendencies of their participating relative. The target sample size for Group 1 is 35 patients.
  •   Patients will be subdivided into two groups. Group 2 includes patients, which are in outpatient's psychotherapy because of an anxiety disorder, obsessive-compulsive disorder or a trauma and stress-related disorder. The remission or persistence of the disorders will be examined with a structured interview. The aggressive behavioral tendencies, depressive symptoms, anxiety symptoms and psychosomatic symptoms of the patients will be surveyed by questionnaires. The patients will be required to describe the aggressive behavioral tendencies of their participating relative. The target sample size of group 1 consists of 35 patients.
  •   Group 3 includes the relatives of the participating patients. The aggressive behavioral tendencies, depressive symptoms, anxiety symptoms and psychosomatic symptoms of the relatives will be surveyed by questionnaires. The relatives will be required to describe the aggressive behavioral tendencies of their participating relative (the patient). Overall the two patients groups will consist of 70 patients, and for every patient, one relative will be included.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Examination of the concordance of the foreign-description and the self-description of aggressive behavioral tendencies (test inventory of autoaggressive and extraneous aggressive behavior, TAV) of outpatients and their relatives. Thereby both the patients and their relatives describe the aggressive behavioral tendencies reciprocally. Ratings of Quality and intensity of the relationship between the patients and their relatives will be taken into account for this analyses.

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Secondary Outcome

Testing the hypothesis of increased aggressive behavioral tendencies for patients with unipolar affective disorders compared to patients with anxiety disorders, obsessive-compulsive-disorders, trauma and stress-related disorders. The aggressive behavioral tendencies will be measured with the TAV. Testing the hypothesis of an association between the aggressive behavioral tendencies and the depressive symptoms for both the patient subgroups and the whole sample (including the relatives of the patientes). Depressive symptoms will be measured with the beck depression inventory revision (BDI-II).
Testing the hypothesis of increased aggressive behavioral tendencies for patients with unipolar affective disorders compared to their relatives.
For all patient, the fulfillment of the diagnostic criteria of mental disorders will be assessed with a structured clinical interview (MINI-DIPS) for both retrospectives for the symptomology at the start of the therapy and for the current time-point. The patient groups will be divided by their symptomology at the start of the therapy in group 1 (unipolar affective disorders) and group 2 (anxiety disorders, obsessive-compulsive disorders, trauma and stress-related disorders). The persistence (or Remission) of the symptomology will be taken into account for the analyses.
Anxiety symptoms and psychosomatic symptoms are assessed with die Mini-Symptom-checklist. Associations between the aggressive behavioral tendencies and the anxiety symptoms and the psychosomatic symptoms will be examined.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/06/21
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients: Outpatients of psychotherapeutic treatment. Patients had to fulfill the diagnosis of a unipolar affective disorder (F32, F33), an anxiety disorder (F40, F41), an obsessive-compulsive disorder (F42) or trauma and stress-related disorder (F43) at the start of the therapy (retrospectively assessed).
Patients and participating relatives: Minimum age 18 years.

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Exclusion Criteria

Patients: Comorbidity between a unipolar affective disorder and an anxiety disorder. Comorbidity between a unipolar affective disorder and an obsessive-compulsive disorder. Comorbidity between a unipolar affective disorder and a trauma and stress-related disorder. Diagnosis of a psychotic disorder or a personality disorder.
Participating relatives: None.

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Addresses

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    • Universität des SaarlandesKlinische Psychologie und Psychotehrapie
    • Ms.  Prof. Dr.  Tanja  Michael 
    • Campus, Geb. A1.3
    • 66123  Saarbrücken
    • Germany
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    • Universität des SaarlandesKlinische Psychologie und Psychotherapie
    • Mr.  Christian  Schanz 
    • Campus, Geb. A1.3
    • 66123  Saarbrücken
    • Germany
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    • Universität des SaarlandesKlinische Psychologie und Psychotherapie
    • Mr.  Christian  Schanz 
    • Campus, Geb. A1.3
    • 66123  Saarbrücken
    • Germany
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Sources of Monetary or Material Support

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    • Universität des SaarlandesKlinische Psychologie und Psychotehrapie
    • Ms.  Prof. Dr.  Tanja  Michael 
    • Campus, Geb. A1.3
    • 66123  Saarbrücken
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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