NCT06606002

Brief Summary

The goal of this randomized and controlled trial is to assess the effectiveness of group schema therapy in the treatment of adolescents with borderline symptoms. The intervention utilizes self-recorded video material as an experiential method. The intervention comprises 30 group sessions and 8 individual sessions. Additionally, there are group sessions for the participants' parents. Participants in the control group receive treatment as usual.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started Aug 2025

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress16%
Aug 2025Dec 2029

First Submitted

Initial submission to the registry

September 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

September 18, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

adolescentsborderline disorderschema therapyrandomized controlled study

Outcome Measures

Primary Outcomes (1)

  • Borderline Symptom List - Short version

    From enrollment to the end of treatment at 12 months

Secondary Outcomes (5)

  • Young Schema Questionnaire Short Form 2 -Extended

    From enrollment to the end of treatment at 12 months

  • Schema Mode Inventory

    From enrollment to the end of treatment at 12 months

  • Patient Health Questionnaire-9

    From enrollment to the end of treatment at 12 months

  • Child and Adolescent Trauma Screen

    From enrollment to the end of treatment at 12 months

  • General Anxiety Disorder-7

    From enrollment to the end of treatment at 12 months

Study Arms (2)

Group schema therapy

EXPERIMENTAL

The group schema therapy intervention includes 30 group sessions and 8 individual sessions for the participants, and 9 group sessions for the participants' parents.

Behavioral: Group schema therapy

Control

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as Usual (TAU)

Interventions

Group schema therapy based on the model by Farrell and Shaw, which is complemented with separate group sessions for the participants\' parents

Group schema therapy

TAU typically comprises visits at the outpatient clinic with variable frequency and content

Control

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The participant fulfills at least three diagnostic criteria for borderline personality disorder as assessed by means of the SCID-II structured clinical interview
  • The participant and the participant's parent(s) are able to commit to the research protocol for the entire duration of the study
  • The participant is able to participate in a research intervention in Finnish and fill out the study questionnaires in Finnish

You may not qualify if:

  • The participant currently has psychotic symptoms or a serious risk of suicide
  • The participant has been diagnosed with an intellectual disability or an autism spectrum disorder
  • The main clinical diagnosis of the participant is a substance abuse disorder or substance use would endanger commitment to the research intervention
  • The participant has another illness or symptom that endangers the participant's ability to complete the study
  • The participant receives some other treatment specifically aimed at borderline personality disorder symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Southwest Finland, 20700, Finland

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Max Karukivi, MD, PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Karukivi, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 20, 2024

Study Start

August 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations