NCT06105502

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Dec 2023May 2028

First Submitted

Initial submission to the registry

August 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

4.4 years

First QC Date

August 25, 2023

Last Update Submit

November 21, 2024

Conditions

Keywords

psychotherapysupervisionstudent learningpatient outcomes

Outcome Measures

Primary Outcomes (14)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Change from pre-treatment to immediately after the end of psychotherapy

Other Outcomes (5)

  • Psychotherapy summary

    Student and patient data immediately after the end of psychotherapy

  • Cognitive Therapy Scale-Revised (CTS-R)

    At first session, first treatment session, fifth treatment session, and last treatment session

  • Supervision Adherence and Guidance Evaluation (Short-SAGE)

    At first session, first treatment session, fifth treatment session, and last treatment session

  • +2 more other outcomes

Study Arms (1)

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).

Behavioral: Psychotherapy education

Interventions

Psychotherapy education, including supervision, lectures, and workshops

Psychotherapy students

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Psychotherapy students at the Center for Psychotherapy Education and Research, Karolinska Institutet and Region Stockholm, Sweden

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Psychiatry Research

Stockholm, Sweden

RECRUITING

Study Officials

  • Maria Beckman, PhD

    Center for Psychiatry Research, Karolinska Institutet and Region Stockholm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Beckman, PhD

CONTACT

Markus Jansson-Fröjmark, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

October 27, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

There is no ethical approval in place to allow for sharing IPD.

Locations