NCT06315075 Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial
| NCT ID | NCT06315075 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Self-harm |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2024-01-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this pre-post-follow-up study is to examine how well the treatment Dialectical behavior therapy for adolescents (DBT-A) with a duration of 20 weeks for adolescents with self-harm and suicidal behavior works in routine clinical practice. The main questions it aims to answer are: * to investigate how well DBT-A works after treatment and at 3-month follow-up, measured by episodes of self-harm, suicide attempts, depressive symptoms and quality of life, drop-out from treatment and number of possible participants who decline DBT-A. * to investigate how well DBT-A works at 12 months follow-up * to investigate whether pre-treatment factors can predict who will benefit from treatment
Eligibility Criteria
Inclusion Criteria: * Age 13-18 years * Ongoing or a history of self-harm the last six months; current suicidal behavior (suicidal thoughts or at least one suicide attempt within the previous six months); at least three criteria of Diagnostic and Statistical Manual -5 (DSM-5) Borderline personality disorder (BPD), or the self-destruction criterion of DSM-5 BPD in addition to minimum two subthreshold criteria as assessed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) (First et al., 2016) * Fluency in Norwegian * One parent/trusted adult that can participate together with the adolescent. Exclusion Criteria: * Intellectual disability * Significant learning or language impairments * Autism spectrum disorder * Anorexia Nervosa * Any psychotic disorder * Substance abuse disorder. These patients will be offered treatment as usual at their local outpatient clinic.
Contact & Investigator
Gro Janne H. Wergeland, MD, PhD
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT06315075 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Self-harm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06315075 currently recruiting?
Yes, NCT06315075 is actively recruiting participants. Contact the research team at gneh@helse-bergen.no for enrollment information.
Where is the NCT06315075 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT06315075 clinical trial?
NCT06315075 is sponsored by Haukeland University Hospital. The principal investigator is Gro Janne H. Wergeland, MD, PhD at Haukeland University Hospital. The trial plans to enroll 140 participants.