Universität Wien
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200089 SE Vertiefungsseminar: Klinische Psychologie und Gesundheitspsychologie (2023S)

Randomisierte Studien in der Evaluation psychologischer Interventionen

4.00 ECTS (2.00 SWS), SPL 20 - Psychologie
Prüfungsimmanente Lehrveranstaltung

Vertiefungsseminare können nur für das Pflichtmodul B verwendet werden! Eine Verwendung für das Modul A4 Freie Fächer ist nicht möglich.


Hinweis: Ihr Anmeldezeitpunkt innerhalb der Frist hat keine Auswirkungen auf die Platzvergabe (kein "first come, first served").


max. 20 Teilnehmer*innen
Sprache: Deutsch


Termine (iCal) - nächster Termin ist mit N markiert

1. Introduction: Hierarchy of evidence – from single case studies to RCTs; PICO questions; selecting an RCT to use in this seminar
2. Designing trials that are fit for purpose: Pragmatic (effectiveness) versus explanatory (efficacy) trials [reading material: Thorpe 2009; Loudon 2015; precis-2.org]
3. Trial design; randomisation, allocation concealment, and blinding [Moher 2010, items 8-11, Box 2-4; consort-statement.org]
4. Whom is this trial about? Sample size, the intention-to-treat principle, per-protocol analysis, and dealing with missing data [Moher 2010, item 7, Fig 1, Box 6]
5. Replicability of interventions: manuals, treatment fidelity, therapist effects [Boutron 2017; Hawe 2004; Hoffmann 2014; Waltz] 1993; What is an appropriate control group? [Gold 2015; Wampold 2015]
6. Clinical outcomes, surrogate outcomes, and biomarkers
7. Appropriate and replicable statistical analysis
9-11. Presentations by students
12. Meta-analysis, risk of bias assessment, grading the evidence; any remaining topics and questions [Higgins 2022, Chapter 8]

Dienstag 07.03. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 14.03. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 21.03. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 28.03. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 18.04. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 09.05. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 16.05. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 23.05. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 06.06. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 13.06. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Dienstag 20.06. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5
Prominentenzimmer Hauptgebäude, Tiefparterre Hof 4
Dienstag 27.06. 16:45 - 18:15 Hörsaal H Psychologie KG Liebiggasse 5


Ziele, Inhalte und Methode der Lehrveranstaltung

Randomised controlled trials (RCTs) are generally regarded as the gold standard in the evaluation of health-related interventions. If conducted appropriately, they can provide more reliable evidence of intervention effects than any other research design. However, conducting high-quality RCTs of psychological interventions is particularly difficult for several reasons. These include the difficulty of conducting interventions in a consistent way across intervention providers and participants (treatment fidelity); the difficulty of blinding participants, intervention providers, and outcome assessors; and the difficulty of finding an appropriate control or comparison intervention. In contrast to pharmacological development, where the need for regulatory approval imposes additional pressure towards rigorous trial design, conduct, and reporting, the lack of a corresponding process in psychological interventions may contribute further to an imbalance in methodological rigour.
This seminar provides you with an overview of methodological considerations when designing, conducting, analysing and reporting RCTs of psychological interventions. You will find and use (at least) one RCT in an area of your interest and apply these methodological considerations to that trial. At the end of this seminar, you will be able to critically appraise the methodological quality of RCTs of psychological interventions, and you will also have the basic knowledge needed for designing such RCTs yourself.

Art der Leistungskontrolle und erlaubte Hilfsmittel

Oral presentations, written assignments, participation.
Regular attendance at the seminar sessions (min. 80%) is a prerequisite for successful completion of the seminar.

Mindestanforderungen und Beurteilungsmaßstab

Comfortable with reading scientific literature in English; some knowledge of statistics.




Boutron, I., Altman, D. G., Moher, D., Schulz, K. F., Ravaud, P., & Grp, C. N. (2017). CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med, 167(1), 40-+. https://doi.org/10.7326/M17-0046
Gold, C. (2015). Quantitative psychotherapy outcome research: Methodological issues. In O. C. G. Gelo, A. Pritz, & B. Rieken (Eds.), Psychotherapy Research: Foundations, Process, and Outcome (pp. 537–558). Springer. https://doi.org/10.1007/978-3-7091-1382-0_26
Hawe, P., Shiell, A., & Riley, T. (2004). Complex interventions: How ”out of control” can a randomised trial be? BMJ, 328, 1561–1563.
Higgins, J. P. T., Thomas, J., Chandler, J., Cumpston, M., Li, T., Page, M. J., & Welch, V. A. (2022). Cochrane Handbook for Systematic Reviews of Interventions (version 6.3, updated February 2022). https://training.cochrane.org/handbook
Hoffmann, T. C., Glasziou, P. P., Boutron, I., Milne, R., Perera, R., Moher, D., Altman, D. G., Barbour, V., Macdonald, H., Johnston, M., Lamb, S. E., Dixon-Woods, M., McCulloch, P., Wyatt, J. C., Chan, A. W., & Michie, S. (2014). Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ, 348, g1687. https://doi.org/10.1136/bmj.g1687
Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K. E., & Zwarenstein, M. (2015). The PRECIS-2 tool: Designing trials that are fit for purpose. BMJ, 350. https://doi.org/10.1136/bmj.h2147
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010). CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ, 340, c869. https://doi.org/10.1136/bmj.c869
Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., Tunis, S., Bergel, E., Harvey, I., Magid, D. J., & Chalkidou, K. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers. Journal of Clinical Epidemiology, 62, 464–475. https://doi.org/10.1016/j.jclinepi.2008.12.011
Waltz, J., Addis, M. E., Koerner, K., & Jacobson, N. S. (1993). Testing the integrity of a psychotherapy protocol: Assessment of adherence and competence. J Consult Clin Psychol, 61(4), 620–630. https://doi.org/10.1037/0022-006X.61.4.620
Wampold, B. E., & Imel, Z. E. (2015). The great psychotherapy debate: The evidence for what makes psychotherapy work (2nd ed.). Routledge.

Zuordnung im Vorlesungsverzeichnis

Letzte Änderung: Fr 16.06.2023 11:47