ISRCTN ISRCTN19173895
DOI https://doi.org/10.1186/ISRCTN19173895
Secondary identifying numbers WE 4654/10-1; KU 3790/2-1
Submission date
06/12/2019
Registration date
10/12/2019
Last edited
09/01/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Psychotherapy is highly effective and widely acknowledged for treating various mental disorders. In terms of methods for teaching effective psychotherapeutic approaches and competencies, there has been a lack of investigation. Training and supervision are the main strategies for teaching therapist competencies. Standardized role plays with simulated patients (trained persons playing someone with a mental disorder) are useful for evaluating training approaches. In medical education, this procedure is now internationally established. However, little use has been made so far of standardized role playing to evaluate training and supervision in the area of clinical psychology and psychotherapy. Yet, this approach has a considerable potential for systemizing research. During the first phase of the research project, standardized role playing will be adapted to assess therapist competencies in clinical-psychological practice. In the second phase, standardized role plays are used to evaluate methods for training and supervision. In two experiments, central approaches for treating depression are trained (cognitive restructuring and behavioral activation). The first experiment compares an active training approach (model learning) with a passive one (reading the manual). The second experiment compares two methods of supervision (verbal report vs video analysis).

Who can participate?
Psychology students

What does the study involve?
In each experiment, students are randomly allocated to the experimental and control groups, and to the order of the training topics (behavioral activation and cognitive strategies or vice versa). Training: In the experimental group, participants watch a video of an experienced psychotherapist who skillfully demonstrates behavioral activation (Video 1) and cognitive strategies (Video 2) with an SP demonstrating a depressive disorder. In the control group, participants watch two unspecific learning tutorials.
Supervision: In the experimental group, participants show their video on behavioral activation (Video 1) and on cognitive techniques (Video 2) of an interaction with an SP demonstrating a depressive disorder to a supervisor (behaviorally-based). In the control group, participants report their experiences with the role plays to a supervisor (verbally-based supervision).
Each student takes part in three role plays (before, after and three-month follow-up) which are all videotaped. Two independent raters assess the therapist competence of each role play on the basis of an established competence scale.

What are the possible benefits and risks of participating?
Participants will contribute to the further development of training and supervision methods. Participation may be associated with anxiety during the video recordings.

Where is the study run from?
University of Potsdam (Germany)

When is the study starting and how long is it expected to run for?
June 2019 to March 2023

Who is funding the study?
German Research Foundation

Who is the main contact?
Dr Franziska Kühne
dr.franziska.kuehne@uni-potsdam.de

Contact information

Dr Franziska Kühne
Scientific

Karl-Liebknecht-Str. 24-25
Potsdam
14476
Germany

ORCiD logoORCID ID 0000-0001-9636-5247
Phone +49 (0)331/977-2096
Email dr.franziska.kuehne@uni-potsdam.de

Study information

Study designSingle-center randomized-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Scientific titleSimulated patients in training and supervision for the evaluation of therapeutic competencies
Study hypothesisPost-training, psychology students randomized to the intervention group (i.e., modeling) will display more therapeutic competencies than students in the control group (i.e., reading written instructions; hypothesis 1).
These differences will persist until 3-month follow-up (hypothesis 2).

Post-supervision, psychology students randomized to the intervention group (i.e., supervision based on video sessions) will display more therapeutic competencies than students in the control group (i.e., supervision based on verbal reporting; hypothesis 3).
These differences will persist until 3-month follow-up (hypothesis 4).
Ethics approval(s)Approved 23/05/2018 by the University of Potsdam ethics review committee (Universität Potsdam, Ethikkommission des Senats, Gremienverwaltung, Nadine Mohaupt, Am Neuen Palais 10, 14469 Potsdam, Germany; Tel: +49 (0)331 977 1791; Email: nadine.mohaupt@uni-potsdam.de), ref: 9/2018
ConditionTherapeutic competence
InterventionParticipants (i.e., bachelor and master students included either as trainees or supervisees) will conduct therapy sessions with standardized patients. They will be randomized in a 1:1 manner by computer-generated numbers and allocated to the experimental or control groups, and to the order of the training topics (behavioral activation and cognitive strategies or vice versa). The allocation will be implemented by a researcher independent of the role plays.

Training (modeling vs written instructions)
Supervision (based on video sessions vs based on verbal reporting)

Training: In the experimental group, participants will watch a video of an experienced psychotherapist who skillfully demonstrates behavioral activation (Video 1) and cognitive strategies (Video 2) with an SP demonstrating a depressive disorder. In the control group, participants will watch two unspecific learning tutorials.

Supervision: In the experimental group, participants will show their video on behavioral activation (Video 1) and on cognitive techniques (Video 2) of an interaction with an SP demonstrating a depressive disorder to a supervisor (behaviorally-based). In the control group, participants will report their experiences with the role plays to a supervisor (verbally-based supervision).

Total duration of the first appointment: 3.5 hours, and of the follow-up appointment: 1.5 hours.
Intervention typeOther
Primary outcome measureMeasured at pre, post- and 3-month follow-up:
1. Psychotherapeutic competencies measured via the Cognitive Therapy Scale (CTS)
2. Therapeutic techniques measured using a self-developed checklist
Secondary outcome measuresMeasured at pre, post- and 3-month follow-up unless otherwise specified:
1. Therapeutic alliance measured using the Helping Alliance questionnaire (HAQ)
2. Empathy measured via the Empathy Scale
3. Therapeutic adherence measured using the Cognitive-Behavioral Therapy Adherence Scale (CBT-AS)
4. Therapeutic knowledge evaluated by multiple choice questions and case vignettes
5. Anxiety measured by the state-trait-anxiety (STAI)
6. Authenticity measured by the Authenticity of Patient Demonstrations (APD) scale
7. Counseling skills measured using the Helping Skills Measure
8. Negative therapist effects measured using self-developed questionnaire
9. Personality measured by the Big Five Inventory (BFI-K) at post-measurement
10. Allegiance effects measured using self-developed questionnaire at pre-measurement
11. The individual perception of the study measured using a self-developed questionnaire at post- measurement and 3-month follow-up
12. Demographic data measured using a self-developed questionnaire at pre-measurement and 3-month follow-up
Overall study start date15/06/2019
Overall study end date13/03/2023

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participants136
Total final enrolment70
Participant inclusion criteria1. Psychology students
2. Informed consent (i.e., agreement to the video recordings)
Participant exclusion criteria1. Currently in psychotherapeutic treatment
2. Insufficient German language skills
Recruitment start date04/12/2019
Recruitment end date01/03/2023

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Potsdam
14476
Germany

Sponsor information

University of Potsdam
University/education

Am Neuen Palais 10
Potsdam
14469
Germany

Phone +49 (0)331/977-0
Email buero.praesident@uni-potsdam.de
Website https://www.uni-potsdam.de/en

Funders

Funder type

Research organisation

Deutsche Forschungsgemeinschaft
Government organisation / National government
Alternative name(s)
German Research Association, German Research Foundation, DFG
Location
Germany

Results and Publications

Intention to publish date31/12/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned protocol publication in a peer-reviewed journal. Planned publication of the study results in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available. Since making the individual participant data publicly available was not covered by the ethics vote, they will be held on a password-protected computer at the researchers' department until deletion (after 10 years) is prescribed.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 18/03/2020 19/03/2020 Yes No
Interim results article proof-of-concept trial 15/12/2022 16/12/2022 Yes No
Results article 28/11/2024 09/01/2025 Yes No

Editorial Notes

09/01/2025: Publication reference added.
18/12/2023: The intention to publish date has been changed from 31/12/2023 to 31/12/2024.
15/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 01/03/2023.
2. The overall trial end date was changed from 15/06/2023 to 13/03/2023.
3. Total final enrolment added.
16/12/2022: Publication reference added.
11/07/2022: The following changes have been made:
1. Recruitment has been resumed.
2. The recruitment end date has been changed from 31/12/2021 to 31/03/2023.
3. The overall trial end date has been changed from 15/06/2022 to 15/06/2023 and the plain English summary updated accordingly.
4. The intention to publish date has been changed from 31/12/2022 to 31/12/2023.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
19/03/2020: Publication reference added.
09/12/2019: Trial's existence confirmed by University of Potsdam ethics review committee.