Condition category
Not Applicable
Date applied
06/12/2019
Date assigned
10/12/2019
Last edited
17/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

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 June 2022

Who is funding the study?
German Research Foundation

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Franziska Kühne

ORCID ID

https://orcid.org/0000-0001-9636-5247

Contact details

Karl-Liebknecht-Str. 24-25
Potsdam
14476
Germany
+49 (0)331/977-2096
dr.franziska.kuehne@uni-potsdam.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

WE 4654/10-1; KU 3790/2-1

Study information

Scientific title

Simulated patients in training and supervision for the evaluation of therapeutic competencies

Acronym

Study hypothesis

Post-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

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

Study design

Single-center randomized-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Therapeutic competence

Intervention

Participants (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 type

Other

Phase

Drug names

Primary outcome measure

Measured 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 measures

Measured 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 trial start date

15/06/2019

Overall trial end date

15/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Psychology students
2. Informed consent (i.e., agreement to the video recordings)

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

136

Participant exclusion criteria

1. Currently in psychotherapeutic treatment
2. Insufficient German language skills

Recruitment start date

04/12/2019

Recruitment end date

31/12/2021

Locations

Countries of recruitment

Germany

Trial participating centre

University of Potsdam
14476
Germany

Sponsor information

Organisation

University of Potsdam

Sponsor details

Am Neuen Palais 10
Potsdam
14469
Germany
+49 (0)331/977-0
buero.praesident@uni-potsdam.de

Sponsor type

University/education

Website

https://www.uni-potsdam.de/en

Funders

Funder type

Research organisation

Funder name

Deutsche Forschungsgemeinschaft

Alternative name(s)

DFG

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned protocol publication in a peer-reviewed journal. Planned publication of the study results in a high-impact peer-reviewed journal.

IPD sharing statement
The 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.

Intention to publish date

31/12/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/32183859 (added 19/03/2020)

Publication citations

Additional files

Editorial Notes

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.