Diagnosis, PsychiatricDiSkONCT05294094
Learning Diagnostic Skills Online (German: Diagnostik Skills Online Lernen)
A study testing blended learning and teaching format as usual in people with Diagnosis, Psychiatric, run by Ruhr University of Bochum at 3 sites in Germany.
Trial summary
Clinical psychologists give diagnoses to their patients everyday and these diagnoses determine if and how these patients will be treated. Misdiagnoses can have severely adverse effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Psychiatric
- What is being tested?
- blended learning and teaching format as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesGermany
- Study dates
- 12 Apr 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Psychology bachelor students of a cooperating university (Ruhr-University of Bochum, University of Cologne, Philipps-University of Marburg)
Who cannot join
- previous participation in a diagnostic seminar
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Ruhr-University Bochum
Bochum, North Rhine-Westphalia, 44787
University of Cologne
Cologne, North Rhine-Westphalia, 50969
Philipps University of Marburg
Marburg, Hesse, 35032
About this study
Clinical psychologists give diagnoses to their patients everyday and these diagnoses determine if and how these patients will be treated. Misdiagnoses can have severely adverse effects. Therefore, teaching diagnostic skills to clinical psychologists is very important during their undergraduate, graduate and postgraduate training.
One major problem in teaching diagnostics is that there are too few opportunities to practice with real patients due to legal and ethical restrictions. The aim of the DiSkO-project is, therefore, the development and evaluation of a blended learning course to teach diagnostic skills to (future) clinical psychologists.
Read more
In order to make the diagnostic training more practical a series of video files of simulated diagnostic interviews will be presented in an online course. These video files will be divided in different segments and presented with questions and automatic feedback. In a second step, learners will make a transfer to a real face-to-face diagnostic situation with an actor simulating a patient.
The DiSkO- course will be evaluated in a randomized-controlled trial at three universities in Germany (Ruhr-University of Bochum, Philipps University of Marburg, University of Cologne). To test whether students are equally good in administering a diagnostic interview after taking the DiSkO-course compared to students who took part in a traditional face-to-face university course a noninferiority-analysis will be conducted. Furthermore, diagnostic knowledge and attitudes toward evidence-based assessment after taking part in DiSkO vs. the face-to-face course will be compared.
The investigators aim at disseminating the open source DiSkO-course to other universities or institutions of tertiary education in Germany with the aim of improving the diagnostic training for students, better prepare them for their clinical practice and thus improve patients' health care in Germany.
- Conditions
- Diagnosis, Psychiatric
- Being tested
- blended learning, teaching format as usual
- Keywords
- clinical interview, blended learning, diagnostic interview
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blended learningBehavioural
The blended learning course consists of two parts. The first part is an online course with case studies and instructional videos providing basic clinical diagnostic knowledge and the ability to conduct structured clinical interviews. In the second part, learners get to discuss the course content with a teacher, practice their interviewing skills with other students and make a transfer to a real face-to-face diagnostic situation with an actor simulating a patient.
teaching format as usualBehavioural
The teaching format as usual represents the usual teaching of clinical diagnostic knowledge and the ability to conduct structured clinical interviews. Also in this intervention students also have the opportunity to discuss the course content with a teacher, practice their interviewing skills with other students and conduct a structured interview with an actor simulating a patient.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | blended learning Receives: Behavioral: blended learning |
| control group | Active comparator | Teaching format as usual Receives: Behavioral: teaching format as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Measure: Performance in a structured interview
Conducting a 15 minute section of a structured interview with a patient played by an actor. This interview is videotaped and then rated by independent evaluators regarding e.g. rules of correct implementation and clincial interviewing skills.
Measured: 13 weeks
Secondary outcomes (9)
Knowledge Test A
A test of basic clinical diagnostic knowledge developed and previously piloted by the study authors. Using the data from the piloting, two parallel 15-Item versions (A and B) were created, which students answered before and after the intervention.
Measured: 1 week
Knowledge Test B
A test of basic clinical diagnostic knowledge developed and previously piloted by the study authors. Using the data from the piloting, two parallel 15-Item versions (A and B) were created, which students answered before and after the intervention.
Measured: 14 weeks
Münster Questionnaire for the Evaluation of Seminars - revised (MFE-Sr; Thielsch & Hirschfeld, 2010)
7-point Likert scale (min.: 1, max.:7)
The following 6 Items from the MFE-Sr were used:
Item Number 14: "The content of this course was too difficult for me." Item Number 15: "The pace of teaching was too fast for me." Item Number 16: "The time commitment associated with the course overwhelmed me." Item Number 25: "I learned a lot in this course." Item Number 26: "I would recommend this course to other students."
Item 14-16: higher values indicate worse outcome, Item 25-26: higher values indicate better outcome
Measured: 14 weeks
Website-Clarity, Likeability, Informativeness, and Credibility (Web-CLIC; Thielsch & Hirschfeld, 2019)
A 12-item questionnaire measuring a users' subjective view on web content, regarding its clarity, likeability, informativeness and credibility. The whole 12-item scale and one additionally created item regarding the credibility ("I completely trusted the content in DiSkO") were used.
7-point Likert scale (min.: 1, max.:7) higher values indicate better outcome
Measured: 14 weeks
Brief scale for teaching evaluation (Zumbach, Spinath, Schahn, Friedrich & Kögel, 2007)
The following 3 Items were used:
Item Number 1: "The subject matter was appropriately illustrated (e.g. by examples, visualizations, etc.)." Item Number 2: "The course was clearly structured." Item Number 3: "The learning objectives of the course were clearly defined."
7-point Likert scale (min.: 1, max.:7) higher values indicate better outcome
Measured: 14 weeks
Usability Metric for User Experience - Lite (UMUX-Lite; Lewis et al., 2013)
A 2-item scale assessing perceived usability.
7-point Likert scale (min.: 1, max.:7) higher values indicate better outcome
Measured: 14 weeks
Visual Aesthetics of Websites Inventory - Short (VisAWI-S; Moshagen & Thielsch, 2013)
A 4-item scale measuring subjectively perceived aesthetics. The 4-item scale and one additionally created item ("DiSkO is designed to be visually appealing") were used.
7-point Likert scale (min.: 1, max.:7) higher values indicate better outcome
Measured: 14 weeks
Overall impression
One item using the german school grading system ranging from 1 (very good) to 6 (unsatisfactory):
"Overall: I give the course an overall grade of ..."
Measured: 14 weeks
Acceptance of structured interviews questionnaire (Bruchmüller et al., 2011)
A 11-item questionnaire measuring the estimated patient satisfaction with structured interviews.
Item 1:
visual analogue scale (0-100) higher values indicate better outcome
Item 2-11:
4-point Likert scale (min.: 0, max.:3)
Item 2,3,4,5 and 8 higher values indicate worse outcome Item 6,7,9,10 and 11 higher values indicate better outcome
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start12 Apr 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnosis, PsychiatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group vs. control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne, University of Kaiserslautern-Landau, Philipps University Marburg
- Responsible party
- Principal investigator, Ruth von Brachel, Ruhr University of Bochum
- Investigators
- Ruth E von Brachel, Dr., Principal investigator, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294094
- Sponsor's protocol ID
- 16DHB3010
- Acronym
- DiSkO
- Status last verified
- Mar 2022
- First submitted
- 17 Jan 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized IPD will be shared with the exception of demographic data which, due to rare constellations, entail a risk of deanonymization of individual participants. The IPD will be made available via the Internet database Psychdata (https://www.psychdata.de) of the Leibnitz Center for Psychological Information and Documentation.
Publications
Bonnin G, Krober S, Schneider S, Margraf J, Pflug V, Gerlach AL, Slotta T, Christiansen H, Albrecht B, Chavanon ML, Hirschfeld G, In-Albon T, Thielsch MT, von Brachel R. A Blended Learning Course on the Diagnostics of Mental Disorders: Multicenter Cluster Randomized Noninferiority Trial. J Med Internet Res. 2024 Nov 27;26:e54176. doi: 10.2196/54176.
PubMed 39602218
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Diagnostic Skills Online (German: Diagnostik Skills Online Lernen)
- ClinicalTrials.gov ID
- NCT05294094
- Acronym / sponsor ID
- DiSkO / 16DHB3010
- Conditions
- Diagnosis, Psychiatric
- Keywords
- clinical interview, blended learning, diagnostic interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- University of Cologne, University of Kaiserslautern-Landau, Philipps University Marburg
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical psychologists give diagnoses to their patients everyday and these diagnoses determine if and how these patients will be treated. Misdiagnoses can have severely adverse effects. Therefore, teaching diagnostic skills to clinical psychologists is very important during their undergraduate, graduate and postgraduate training.
One major problem in teaching diagnostics is that there are too few opportunities to practice with real patients due to legal and ethical restrictions. The aim of the DiSkO-project is, therefore, the development and evaluation of a blended learning course to teach diagnostic skills to (future) clinical psychologists.
In order to make the diagnostic training more practical a series of video files of simulated diagnostic interviews will be presented in an online course. These video files will be divided in different segments and presented with questions and automatic feedback. In a second step, learners will make a transfer to a real face-to-face diagnostic situation with an actor simulating a patient.
The DiSkO- course will be evaluated in a randomized-controlled trial at three universities in Germany (Ruhr-University of Bochum, Philipps University of Marburg, University of Cologne). To test whether students are equally good in administering a diagnostic interview after taking the DiSkO-course compared to students who took part in a traditional face-to-face university course a noninferiority-analysis will be conducted. Furthermore, diagnostic knowledge and attitudes toward evidence-based assessment after taking part in DiSkO vs. the face-to-face course will be compared.
The investigators aim at disseminating the open source DiSkO-course to other universities or institutions of tertiary education in Germany with the aim of improving the diagnostic training for students, better prepare them for their clinical practice and thus improve patients' health care in Germany.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- intervention group vs. control group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: blended learningblended learning |
| control group | Active comparator | Behavioral: teaching format as usualTeaching format as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Psychology bachelor students of a cooperating university (Ruhr-University of Bochum, University of Cologne, Philipps-University of Marburg)
Key exclusion criteria (1 listed)
- previous participation in a diagnostic seminar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blended learningThe blended learning course consists of two parts. The first part is an online course with case studies and instructional videos providing basic clinical diagnostic knowledge and the ability to conduct structured clinical interviews. In the second part, learners get to discuss the course content with a teacher, practice their interviewing skills with other students and make a transfer to a real face-to-face diagnostic situation with an actor simulating a patient. | Behavioural | intervention group |
| teaching format as usualThe teaching format as usual represents the usual teaching of clinical diagnostic knowledge and the ability to conduct structured clinical interviews. Also in this intervention students also have the opportunity to discuss the course content with a teacher, practice their interviewing skills with other students and conduct a structured interview with an actor simulating a patient. | Behavioural | control group |
Primary outcome
Behavioral Measure: Performance in a structured interview
Time frame: 13 weeks
Conducting a 15 minute section of a structured interview with a patient played by an actor. This interview is videotaped and then rated by independent evaluators regarding e.g. rules of correct implementation and clincial interviewing skills.
9 secondary outcomes
Knowledge Test A
Time frame: 1 week
Knowledge Test B
Time frame: 14 weeks
Münster Questionnaire for the Evaluation of Seminars - revised (MFE-Sr; Thielsch & Hirschfeld, 2010)
Time frame: 14 weeks
Website-Clarity, Likeability, Informativeness, and Credibility (Web-CLIC; Thielsch & Hirschfeld, 2019)
Time frame: 14 weeks
Brief scale for teaching evaluation (Zumbach, Spinath, Schahn, Friedrich & Kögel, 2007)
Time frame: 14 weeks
Usability Metric for User Experience - Lite (UMUX-Lite; Lewis et al., 2013)
Time frame: 14 weeks
Visual Aesthetics of Websites Inventory - Short (VisAWI-S; Moshagen & Thielsch, 2013)
Time frame: 14 weeks
Overall impression
Time frame: 14 weeks
Acceptance of structured interviews questionnaire (Bruchmüller et al., 2011)
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Derived from this study: PubMed 39602218Bonnin G, Krober S, Schneider S, Margraf J, Pflug V, Gerlach AL, Slotta T, Christiansen H, Albrecht B, Chavanon ML, Hirschfeld G, In-Albon T, Thielsch MT, von Brachel R. A Blended Learning Course on the Diagnostics of Mental Disorders: Multicenter Cluster Randomized Noninferiority Trial. J Med Internet Res. 2024 Nov 27;26:e54176. doi: 10.2196/54176.
- Individual participant dataSharing planned: Yes. All anonymized IPD will be shared with the exception of demographic data which, due to rare constellations, entail a risk of deanonymization of individual participants. The IPD will be made available via the Internet database Psychdata (https://www.psychdata.de) of the Leibnitz Center for Psychological Information and Documentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth E von Brachel, Dr. principal investigator
Ruhr-University Bochum
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blended learning and teaching format as usual in people with Diagnosis, Psychiatric, run by Ruhr University of Bochum at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Measure: Performance in a structured interview (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.