- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606002
The Effectiveness of Group Schema Therapy in the Treatment of Borderline Symptoms in Adolescents
The Effectiveness of Group Schema Therapy Utilizing Video Material in the Treatment of Borderline Symptoms in Adolescents: A Randomized and Controlled Intervention Study
Study Overview
Status
Intervention / Treatment
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 15-18 who are being treated at the Adolescent 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Max Karukivi, MD, PhD
- Phone Number: +358 2 313 0000
- Email: max.karukivi@utu.fi
Study Locations
-
-
Southwest Finland
-
Turku, Southwest Finland, Finland, 20700
- Recruiting
- Turku University Hospital
-
Contact:
- Max Karukivi, MD, PhD
- Phone Number: +358 0503274340
- Email: max.karukivi@utu.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Treatment as usual
|
TAU typically comprises visits at the outpatient clinic with variable frequency and content
|
|
Experimental: Group schema therapy
The group schema therapy intervention includes 30 group sessions and 8 individual sessions for the participants, and 9 group sessions for the participants' parents.
|
Group schema therapy based on the model by Farrell and Shaw, which is complemented with separate group sessions for the participants' parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Borderline Symptom List - Short version
Time Frame: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Young Schema Questionnaire Short Form 2 -Extended
Time Frame: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
|
Schema Mode Inventory
Time Frame: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
|
Patient Health Questionnaire-9
Time Frame: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
|
Child and Adolescent Trauma Screen
Time Frame: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
|
General Anxiety Disorder-7
Time Frame: From enrollment to the end of treatment at 12 months
|
From enrollment to the end of treatment at 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Max Karukivi, MD, PhD, University of Turku
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1709/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Borderline Personality Disorder
-
University of California, Los AngelesRecruitingBorderline Personality Disorder | Borderline Personality | BPD - Borderline Personality DisorderUnited States
-
University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
Waypoint Centre for Mental Health CareRecruitingBorderline Personality Disorder (BPD)Canada
-
Mclean HospitalRecruitingBorderline Personality Disorder (BPD)United States
-
University Hospital, MontpellierNot yet recruitingBorderline Personality Disorder | Borderline Personality Disorder (BPD)
-
University Hospital, ToulouseNot yet recruitingBorderline Personality Disorder (BPD) | Infusion of Ketamine in Severe Borderline Personality DisorderFrance
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownBorderline Personality Disorder.Spain
-
Silvia Elisa Hurtado SantiagoCompletedPersonality Disorder, BorderlineSpain
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
Clinical Trials on Group schema therapy
-
Consorci Sanitari del MaresmeDepartment of Health, Generalitat de CatalunyaCompletedBorderline Personality Disorder | Randomized Controlled Trial
-
University of AmsterdamGgz Oost Brabant; Academic Center for Trauma and Personality; Arkin Mental Health...Enrolling by invitationBorderline Personality DisorderNetherlands
-
GGZ Noord-Holland-NoordCompletedAnxiety Disorders | Depressive Symptoms | Anxiety Depression | PersistentNetherlands
-
Paris Nanterre UniversityIsfahan University of Medical SciencesUnknown
-
Maastricht University Medical CenterAcademic Community Mental Health Centre (RIAGG)Completed
-
Institute for Health Economics and Policy, JapanSenzoku Stress Coping Support OfficeRecruiting
-
Norwegian University of Science and TechnologyCompletedPersonality Disorder, Borderline | Avoidant Personality DisorderNorway
-
Butler HospitalNational Institute of Mental Health (NIMH)Completed
-
ArkinTilburg University; Ggz Oost Brabant; GGZ de Viersprong; Stichting Altrecht GGZ; Stichting...RecruitingSevere Personality DisorderNetherlands
-
Region of Southern DenmarkMental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalCompletedDepression | Major Depressive Disorder | Treatment Resistant Depression | Chronic DepressionDenmark