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Borderline SymptomsNCT06606002

The Effectiveness of Group Schema Therapy in the Treatment of Borderline Symptoms in Adolescents

A study testing Group schema therapy and Treatment as Usual (TAU) in people with Borderline Symptoms and Borderline Personality Disorder, run by Turku University Hospital at 1 site in Finland.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 15 to 22 years
What is being tested?
Group schema therapy and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteFinland
Study dates
1 Aug 2025to Dec 2029
Phase
Interventional

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 15 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Max Karukivi, MD, PhD contact

+358 2 313 0000

max.karukivi@utu.fi

Finland1 site, 1 recruiting
  • Turku University Hospital

    Turku, Southwest Finland, 20700

    Max Karukivi, MD, PhD, 0503274340 ext. +358, max.karukivi@utu.fi

    Recruiting

Other trials in Finland

About this study

Official title: The Effectiveness of Group Schema Therapy Utilizing Video Material in the Treatment of Borderline Symptoms in Adolescents: A Randomized and Controlled Intervention Study

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.

Read the detailed description

The goal of this randomized and controlled intervention study is to assess the effectiveness of group schema therapy in the treatment of adolescents with borderline symptoms. Borderline personality disorder (BPD) is a severe and chronic mental health disorder, which features are typically detectable already in adolescence. BPD causes considerable suffering and functional impairment. Treatment recommendations emphasize treating BPD with targeted interventions already in adolescence, but evidence-based treatments in this age group are so far scarce.

The research sample consists of 32 adolescents who participate in a group schema therapy intervention and their 32 controls. The participants are adolescents aged 15-22 who are being treated either at the Adolescent Psychiatry Clinic or Psychiatry Clinic at the Turku University Hospital. The subjects meet at least three diagnostic criteria for BPD based on SCID-II assessment. Adolescents who are at serious suicide risk or with, for example, psychotic symptoms, or another disorder or symptom that endangers commitment to the intervention protocol, are excluded from the study.

The studied intervention is based on Farrell and Shaw's group schema therapy model. The experiential part of the model is strengthened utilizing videos, which are recorded by the participants (VideoTalk). The videos are used to support both individual and group work. The intervention is tailored to be developmentally sensitive for this age group and reinforced with a module to which the participants' parents participate.

The intervention comprises 30 weekly group sessions and 8 individual sessions. Eight adolescents participate in one group, and four groups are carried out during the study. The participants' parents have 9 group sessions, some of which the adolescents also participate in. The duration of the intervention is approximately one year. The control group receives treatment as usual.

Both the intervention and control groups response to the research questionnaires at five time points (baseline, 3 months, 6 months, 12 months, 2 years). The primary response variable is the change in the BPD symptoms between entering the study and the end of the intervention. As secondary response variables, changes in, for example, the participants' early maladaptive schemas, schema modes, and depressive and anxiety symptoms are assessed. After the end of the intervention, the study includes a one-year follow-up period and two years after the intervention, follow-up data is collected from the participants' medical reports. The study also includes qualitative sub-studies.

The intervention groups will be carried out during the years 2025-2027. A new group is always started overlapping with the previous group. Results regarding the primary response variable will be completed at the end of 2027. The entire research material will be completed at the end of 2029.

Being tested
Group schema therapy, Treatment as Usual (TAU)
Keywords
adolescents, borderline disorder, schema therapy, randomized controlled study
Medical subject headings
Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group schema therapyBehavioural

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

  • Treatment as Usual (TAU)Behavioural

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

Study groups in NCT06606002
Study groupRoleWhat they receive
Group schema therapyExperimentalThe group schema therapy intervention includes 30 group sessions and 8 individual sessions for the participants, and 9 group sessions for the participants' parents.
Receives: Behavioral: Group schema therapy
ControlActive comparatorTreatment as usual
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Borderline Symptom List - Short version

    Measured: From enrollment to the end of treatment at 12 months

Secondary outcomes (5)
  1. Young Schema Questionnaire Short Form 2 -Extended

    Measured: From enrollment to the end of treatment at 12 months

  2. Schema Mode Inventory

    Measured: From enrollment to the end of treatment at 12 months

  3. Patient Health Questionnaire-9

    Measured: From enrollment to the end of treatment at 12 months

  4. Child and Adolescent Trauma Screen

    Measured: From enrollment to the end of treatment at 12 months

  5. General Anxiety Disorder-7

    Measured: From enrollment to the end of treatment at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start1 Aug 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06606002
Sponsor's protocol ID
T1709/2024
Status last verified
Aug 2026
First submitted
18 Sep 2024
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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