Student EducationNCT06105502
Systematic Evaluation of Psychotherapy Training: Supervision, Student Learning, and Patient Outcomes
An observational study of Student Education, run by Region Stockholm at 1 site in Sweden.
Trial summary
The project is a longitudinal observation study that aims to systematically evaluate selected parts of the material collected within the framework of the psychotherapy training conducted at the Center of Psychotherapy Education and Research unit at Karolinska Institutet and Region Stockholm, Sweden. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Student Education
- What is being tested?
- Psychotherapy education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 417 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Psychotherapy students at the Center for Psychotherapy Education and Research, Karolinska Institutet and Region Stockholm, Sweden
Who may be able to join
- Students at one of the following courses/programs: Primary training in evidence-based psychotherapeutic methods (three semesters) and specialty trainee (ST) for doctors in child, adolescent, and adult psychiatry (two semesters), the postgraduate psychotherapist program (six semesters), and the specialist training program for clinical psychologists (six semesters).
- Clinical supervisors for the students in the abovementioned courses/programs.
- Patients in psychotherapy with students in the abovementioned courses/programs as therapists. The patients are regular patients at public health care facilities in psychiatry and primary care.
- Students, supervisors, and patients must consent to inclusion.
Who cannot join
- No exclusion criteria are applied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Center for Psychiatry Research
Stockholm, Stockholm County
Maria Beckman, PhD, +46-70-797 22 65, maria.beckman@ki.se
About this study
Official title: Systematic Evaluation of Psychotherapy Training: Impact of Supervision and Training on Student Learning and Patient Outcomes
The project is a longitudinal observation study that aims to systematically evaluate selected parts of the material collected within the framework of the psychotherapy training conducted at the Center of Psychotherapy Education and Research unit at Karolinska Institutet and Region Stockholm, Sweden. Students at the unit, patients being administered psychotherapy by the students, and supervisors will participate in the study.
The aim of the present study is to investigate the associations between (1) content and quality of psychotherapy supervision, (2) student therapists' competence, and (3) patient outcomes following student-led psychotherapy.
Read the detailed description
The project is a longitudinal observation study that aims to systematically evaluate selected parts of the material collected within the framework of the psychotherapy training conducted at the Center of Psychotherapy Education and Research unit at Karolinska Institutet and Region Stockholm, Sweden, from 2023 - 2028. The courses/programs that will be included in the project are the psychotherapist program (six semesters), the specialist training for psychologists in adult psychiatry (six semesters), the basic training in evidence-based psychotherapeutic methods (three semesters), and the basic training in psychotherapy for residents in child, adolescent, and adult psychiatry (two semesters). The element of the programs that will be evaluated is student-led psychotherapy, in which students conduct psychotherapy with patients in the public health care system.
The study's research subjects are supervisors, students, and their patients from the unit's student-led psychotherapies. Data consists of material that the supervisors and students have collected within the framework of the educational setting; the data are placed and stored on a secure digital platform (BASS). For objective estimates, the project also intends to code selected audio-recorded psychotherapy and supervision sessions.
The primary research questions are:
- Do psychotherapy students' general and specific psychotherapy competence increase over time during training?
- Can statistically significant and/or clinically meaningful patient improvements be observed after student-led psychotherapy?
- Is students' psychotherapy competence significantly associated with patient outcomes?
- Are aspects (content and quality) of the psychotherapy supervision setting significantly related to improved student therapists' competence?
The project also aims to psychometrically evaluate (validity and reliability) some of the included instruments.
- Conditions
- Student Education
- Being tested
- Psychotherapy education
- Keywords
- psychotherapy, supervision, student learning, patient outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy educationBehavioural
Psychotherapy education, including supervision, lectures, and workshops
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy students | The participating psychotherapy students will come from the following courses at the Center for Psychotherapy Education and Research: the psychotherapist program (six semesters), the specialist training for psychologists in adult psychiatry (six semesters), the basic training in evidence-based psychotherapeutic methods (three semesters), and the basic training in psychotherapy for residents in child, adolescent, and adult psychiatry (two semesters). Receives: Behavioral: Psychotherapy education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Generalized Anxiety Disorder Assessment 7 (GAD-7)
The GAD-7 is originally a measure for generalized anxiety disorder, but it is also frequently used to assess general anxiety. The form consists of seven items with a four-point scale. The range is 0-21 points. An eight item describes how disruptive the anxiety is from not at all to very significant, which is not included in the total score. The GAD-7 has been translated into Swedish and has shown good psychometric properties in terms of both reliability and validity.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a well-established depression questionnaire consisting of nine items that correspond to the diagnostic criteria for a major depressive episode according to the DMS-5. How often the symptoms have bothered the patient in the past two weeks is rated by the patient, at the start and end of treatment, on a four-point scale. The range is 0-27 points. The PHQ-9 has been translated into Swedish and has good internal consistency and test-retest reliability.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The WHO Disability Assessment Schedule (WHODAS 2.0)
The WHODAS 2.0 is a widely used generic assessment instrument that provides a standardized method for measuring health and disability across cultures. The form is based on a set of questions from the International Classification of Functioning, Disability, and Health (ICF) that are sufficiently reliable and sensitive to measure changes after interventions. The form is available in seven different versions with 36 questions, 12 questions, and 12+24 questions as interview-administered, self-administered, and proxy-administered, respectively. In the project, the self-administered 12-question form is used.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is a widely used instrument for identifying hazardous and harmful alcohol consumption. The instrument was initially developed by the WHO and consists of a ten-item questionnaire designed to measure three domains: consumption, dependence, and alcohol-related harm. The project uses a cut-off point of 5 points as an indication of mild alcohol use disorder. The project uses the AUDIT-C, which includes the first three questions of the AUDIT.
Measured: Change from pre-treatment to immediately after the end of psychotherapy for those patients scoring above the cut-off at pre-treatment
The Sleep Condition Indicator (SCI)
The SCI will be used to measure sleep disorders. The SCI contains eight questions regarding nocturnal symptoms, function, performance, duration, frequency, and severity. The form is translated into Swedish, and the psychometric properties have been shown in studies to be acceptable to good.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Liebowitz Social Anxiety Scale, self-report (LSAS-SR)
The LSAS-SR is only used for patients with social anxiety disorder or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Panic Disorder Severity Scale - Self-rated (PDSS-SR)
The PDSS-SR is only used for patients with panic disorder or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Penn State Worry Questionnaire (PSWQ)
The PSWQ is only used for patients with generalized anxiety disorder or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Posttraumatic Stress Disorder Checklist, version 5 (PCL-5)
The PCL-5 is only used for patients with posttraumatic stress disorder or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Obsessive Compulsive Inventory-Revised (OCI-R)
The OCI-R is only used for patients with obsessive-compulsive disorder or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Perceived Stress Scale-10 (PSS-10)
The PSS-10 is only used for patients with stress or burnout problems or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Short Health Anxiety Inventory-14 (SHAI-14)
The SHAI-14 is only used for patients with health anxiety problems or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Eating Disorder Examination Questionnaire (EDE-Q)
The EDE-Q is only used for patients with eating disorders or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
The Drug Use Disorders Identification Test (DUDIT)
The DUDIT is only used for patients with drug problems or similar.
Measured: Change from pre-treatment to immediately after the end of psychotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Student EducationStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 417 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Maria Beckman, PhD, Principal investigator, Center for Psychiatry Research, Karolinska Institutet and Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105502
- Sponsor's protocol ID
- 2023-03668-01
- Other IDs
- 2023
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no ethical approval in place to allow for sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Evaluation of Psychotherapy Training: Impact of Supervision and Training on Student Learning and Patient Outcomes
- ClinicalTrials.gov ID
- NCT06105502
- Acronym / sponsor ID
- 2023-03668-01
- Conditions
- Student Education
- Keywords
- psychotherapy, supervision, student learning, patient outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 417 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Oct 2023 (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.
The project is a longitudinal observation study that aims to systematically evaluate selected parts of the material collected within the framework of the psychotherapy training conducted at the Center of Psychotherapy Education and Research unit at Karolinska Institutet and Region Stockholm, Sweden. Students at the unit, patients being administered psychotherapy by the students, and supervisors will participate in the study.
The aim of the present study is to investigate the associations between (1) content and quality of psychotherapy supervision, (2) student therapists' competence, and (3) patient outcomes following student-led psychotherapy.
Detailed description
The project is a longitudinal observation study that aims to systematically evaluate selected parts of the material collected within the framework of the psychotherapy training conducted at the Center of Psychotherapy Education and Research unit at Karolinska Institutet and Region Stockholm, Sweden, from 2023 - 2028. The courses/programs that will be included in the project are the psychotherapist program (six semesters), the specialist training for psychologists in adult psychiatry (six semesters), the basic training in evidence-based psychotherapeutic methods (three semesters), and the basic training in psychotherapy for residents in child, adolescent, and adult psychiatry (two semesters). The element of the programs that will be evaluated is student-led psychotherapy, in which students conduct psychotherapy with patients in the public health care system.
The study's research subjects are supervisors, students, and their patients from the unit's student-led psychotherapies. Data consists of material that the supervisors and students have collected within the framework of the educational setting; the data are placed and stored on a secure digital platform (BASS). For objective estimates, the project also intends to code selected audio-recorded psychotherapy and supervision sessions.
The primary research questions are:
- Do psychotherapy students' general and specific psychotherapy competence increase over time during training?
- Can statistically significant and/or clinically meaningful patient improvements be observed after student-led psychotherapy?
- Is students' psychotherapy competence significantly associated with patient outcomes?
- Are aspects (content and quality) of the psychotherapy supervision setting significantly related to improved student therapists' competence?
The project also aims to psychometrically evaluate (validity and reliability) some of the included instruments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy students | – | Behavioral: Psychotherapy educationThe participating psychotherapy students will come from the following courses at the Center for Psychotherapy Education and Research: the psychotherapist program (six semesters), the specialist training for psychologists in adult psychiatry (six semesters), the basic training in evidence-based psychotherapeutic methods (three semesters), and the basic training in psychotherapy for residents in child, adolescent, and adult psychiatry (two semesters). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Psychotherapy students at the Center for Psychotherapy Education and Research, Karolinska Institutet and Region Stockholm, Sweden
Key inclusion criteria (4 listed)
- Students at one of the following courses/programs: Primary training in evidence-based psychotherapeutic methods (three semesters) and specialty trainee (ST) for doctors in child, adolescent, and adult psychiatry (two semesters), the postgraduate psychotherapist program (six semesters), and the specialist training program for clinical psychologists (six semesters).
- Clinical supervisors for the students in the abovementioned courses/programs.
- Patients in psychotherapy with students in the abovementioned courses/programs as therapists. The patients are regular patients at public health care facilities in psychiatry and primary care.
- Students, supervisors, and patients must consent to inclusion.
Key exclusion criteria (1 listed)
- No exclusion criteria are applied.
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 |
|---|---|---|
| Psychotherapy educationPsychotherapy education, including supervision, lectures, and workshops | Behavioural | Psychotherapy students |
Primary outcome
The Generalized Anxiety Disorder Assessment 7 (GAD-7)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The GAD-7 is originally a measure for generalized anxiety disorder, but it is also frequently used to assess general anxiety. The form consists of seven items with a four-point scale. The range is 0-21 points. An eight item describes how disruptive the anxiety is from not at all to very significant, which is not included in the total score. The GAD-7 has been translated into Swedish and has shown good psychometric properties in terms of both reliability and validity.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The PHQ-9 is a well-established depression questionnaire consisting of nine items that correspond to the diagnostic criteria for a major depressive episode according to the DMS-5. How often the symptoms have bothered the patient in the past two weeks is rated by the patient, at the start and end of treatment, on a four-point scale. The range is 0-27 points. The PHQ-9 has been translated into Swedish and has good internal consistency and test-retest reliability.
The WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The WHODAS 2.0 is a widely used generic assessment instrument that provides a standardized method for measuring health and disability across cultures. The form is based on a set of questions from the International Classification of Functioning, Disability, and Health (ICF) that are sufficiently reliable and sensitive to measure changes after interventions. The form is available in seven different versions with 36 questions, 12 questions, and 12+24 questions as interview-administered, self-administered, and proxy-administered, respectively. In the project, the self-administered 12-question form is used.
The Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy for those patients scoring above the cut-off at pre-treatment
The AUDIT is a widely used instrument for identifying hazardous and harmful alcohol consumption. The instrument was initially developed by the WHO and consists of a ten-item questionnaire designed to measure three domains: consumption, dependence, and alcohol-related harm. The project uses a cut-off point of 5 points as an indication of mild alcohol use disorder. The project uses the AUDIT-C, which includes the first three questions of the AUDIT.
The Sleep Condition Indicator (SCI)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The SCI will be used to measure sleep disorders. The SCI contains eight questions regarding nocturnal symptoms, function, performance, duration, frequency, and severity. The form is translated into Swedish, and the psychometric properties have been shown in studies to be acceptable to good.
The Liebowitz Social Anxiety Scale, self-report (LSAS-SR)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The LSAS-SR is only used for patients with social anxiety disorder or similar.
The Panic Disorder Severity Scale - Self-rated (PDSS-SR)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The PDSS-SR is only used for patients with panic disorder or similar.
The Penn State Worry Questionnaire (PSWQ)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The PSWQ is only used for patients with generalized anxiety disorder or similar.
The Posttraumatic Stress Disorder Checklist, version 5 (PCL-5)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The PCL-5 is only used for patients with posttraumatic stress disorder or similar.
The Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The OCI-R is only used for patients with obsessive-compulsive disorder or similar.
The Perceived Stress Scale-10 (PSS-10)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The PSS-10 is only used for patients with stress or burnout problems or similar.
The Short Health Anxiety Inventory-14 (SHAI-14)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The SHAI-14 is only used for patients with health anxiety problems or similar.
The Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The EDE-Q is only used for patients with eating disorders or similar.
The Drug Use Disorders Identification Test (DUDIT)
Time frame: Change from pre-treatment to immediately after the end of psychotherapy
The DUDIT is only used for patients with drug problems or similar.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. There is no ethical approval in place to allow for sharing IPD.
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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.
Maria Beckman, PhD principal investigator
Center for Psychiatry Research, Karolinska Institutet and Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Student Education, run by Region Stockholm at 1 site in Sweden.
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 4 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Beckman, PhD (+46-70-797 22 65, maria.beckman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Generalized Anxiety Disorder Assessment 7 (GAD-7) (time frame: Change from pre-treatment to immediately after the end of psychotherapy). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.