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.
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
- Conditions the study is for
- Borderline Symptoms, Borderline Personality Disorder
- What is being tested?
- Group schema therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- 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.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, Southwest Finland, 20700
Max Karukivi, MD, PhD, 0503274340 ext. +358, max.karukivi@utu.fi
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group schema therapy |
| Control | Active comparator | Treatment 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.
Borderline Symptom List - Short version
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (5)
Young Schema Questionnaire Short Form 2 -Extended
Measured: From enrollment to the end of treatment at 12 months
Schema Mode Inventory
Measured: From enrollment to the end of treatment at 12 months
Patient Health Questionnaire-9
Measured: From enrollment to the end of treatment at 12 months
Child and Adolescent Trauma Screen
Measured: From enrollment to the end of treatment at 12 months
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.
- First posted20 Sep 2024
- Study start1 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Max Karukivi, Turku University Hospital
- Investigators
- Max Karukivi, MD, PhD, Principal investigator, University of Turku
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