Trial document




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  DRKS00027328

Trial Description

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Title

Effectiveness of Out-Patient Group-Psychotherapy - a Naturalistic Longitudinal Study

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Trial Acronym

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URL of the Trial

https://pt-ambulanz.at/forschung/

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Brief Summary in Lay Language

The study examines the effectiveness of the various therapy methods represented at a psychotherapeutic outpatient clinic (pta) in Vienna. For this purpose, patients who take part in group therapy are asked once a month to answer a standardized questionnaire (OQ-45.2) about their symptoms and their state of mind, which has been well evaluated in international psychotherapy research.
We want to clarify whether and when the therapy works and whether certain properties (e.g. age, diagnosis, gender, personality, etc.) have an influence on its effectiveness.

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Brief Summary in Scientific Language

Research - especially in the last two decades - showed that group psychotherapy is generally as effective as individual therapy. However, the results in this area apply mainly to cognitive-behavioral therapy models. For many of the 23 psychotherapy methods recognized in Austria (especially in the group therapy setting) there is still no proof of effectiveness. In addition, the majority of the studies available are RCTs with extremely homogeneous patient groups and very short treatment times - both factors that don’t do justice to the reality of treatment (especially in the German-speaking area).
The study examines the effectiveness of different psychotherapeutic models (psychoanalytical, systemic and humanistic), which have so far been sparsely investigated, in a comparable treatment setting at ÖAGG Psychotherapeutische Ambulanz (pta; an outpatient clinic specialized in group psychotherapy). In addition, different forms of more or less homogeneous groups concerning disorder and target groups are compared.
A special focus is on the recording of dose-effect relationships in a specific treatment setting (long-term slow-open group therapy with different therapeutic models). It will also be possible to make statements about patient, therapist and treatment-specific factors and their influence on the effectiveness of group therapy.
The difficulty of high drop-out rates, which was observed in earlier naturalistic studies, is prevented by a relatively close-knit survey design with monthly administrations of the target questionnaire (OQ-45.2).
In addition, the question of the dose-effect relationship is examined in a more differentiated manner using method triangulation: Ten qualitative interviews with patients who show different patterns in the dose-effect relationship are intended to provide insights into the experiences of patients with the therapy group: For example, patients who a) achieve a reliable change (RCI) after a long time, b) achieve a RCI after a short time, c) show no improvement after a long time, etc.
Thus, the study helps to close the research gap in the area of long-term therapy groups with psychodynamic, humanistic and systemic change models.

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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

  •   DRKS00027328
  •   2021/11/30
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  •   yes
  •   Approved
  •   2021-2459_1-Bef, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   F00-F99 -  Mental and behavioural disorders
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Interventions/Observational Groups

  •   All patients in therapy groups in the psychotherapeutic outpatient clinic (pta) who consent to the study are surveyed monthly using a questionnaire (OQ-45.2).

    In addition, 10 patients will be invited to take part in a narrative interview after the end of therapy.

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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the proportion of patients who achieve a clinically significant change or Reliable Change Index in the course of therapy. These measures can be calculated using the Outcome Questionnaire (OQ45.2), which is administered monthly.
Both the three subscales of the OQ-45.2 (symptom distress, interpersonal relations, social role) and the overall scale are used for this purpose.

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Secondary Outcome

Further outcomes are
1) the dose-effect relationship between the number of therapy units and the achievement of a clinically significant change, which are calculated using the Kaplan-Meier method from the data of the OQ-45.2
2) the influence of patient-, therapist- and treatment-specific factors on the effectiveness, which are calculated by means of significance tests.

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2021/12/01
  •   2000
  •   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

over 18 years
currently participating in one therapy group at ÖAGG-psychotherapeutische Ambulanz (pta)
existing psychiatric disorder

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Exclusion Criteria

no exclusion criteria

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Addresses

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    • ÖAGG-psychotherapeutische Ambulanz gGmbH
    • Ms.  Mag.  Ursula  Freudenthaler 
    • Marxergasse 25
    • 1030  Wien
    • Austria
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    • Bertha von Suttner Privatuniversität St. Pölten GmbH
    • Ms.  Univ.-Prof. Dr.  Aglaja  Przyborski 
    • Campus-Platz 1
    • 3100  St. Pölten
    • Austria
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    • Universitätsklinikum JenaInstitut für Psychosoziale Medizin, Psychotherapie und Psychoonkologie
    • Mr.  Prof. Dr. phil. habil.  Bernhard  Strauß 
    • Stoystraße 3
    • 07740  Jena
    • Germany
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    • ÖAGG-psychotherapeutische Ambulanz
    • Ms.  Mag.  Hannah  Bischof 
    • Marxergasse 25
    • 1030  Wien
    • Austria
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    • ÖAGG-psychotherapeutische Ambulanz
    • Ms.  Mag.  Hannah  Bischof 
    • Marxergasse 25
    • 1030  Wien
    • Austria
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Sources of Monetary or Material Support

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    • ÖAGG-psychotherapeutische Ambulanz gGmbH
    • Ms.  Mag.  Ursula  Freudenthaler 
    • Marxergasse 25
    • 1030  Wien
    • Austria
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Status

  •   Recruiting planned
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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.