Dialectical Behavior Therapy for Adolescents With Self-harm and Suicidal Behavior- an Open Trial

NCT06315075 | Recruiting

• 1 other identifier: 657876
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Self-harm; Suicidal Ideation; Suicide and Self-harm

Keywords

Suicide and Self-harm; Adolescents; Dialectical behavior therapy for adolescents; Routine clinical practice; Effectiveness study

Outcome Measures

Primary Outcomes (2)

• Lifetime Parasuicide Count Interview

  Number of self-harm episodes in the last four weeks categorized by intention and self-harm method, number of suicide attempts, and number of emergency department visits caused by suicidal behavior.

  pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up

• Number of participants in need of emergency department visits caused by suicidal behavior

  Medical record data extraction

  pre, after 20 weeks DBT-A ("post"), at 3 and 12 months follow-up

Secondary Outcomes (4)

• Depressive symptom score measured by Short Mood and Feelings questionnaire (SMFQ)

  pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up

• Health related quality of life measured by SCREENing for and Promotion of Health Related Quality of Life in Children an Adolescents (Kidscreen 10)

  pre, after 20 weeks DBT-A ("post"), 3 and 12 months follow-up

• Barriers to Treatment Participation Scale (BTPS) score

  pre, at dropout at any time between session 1 and end of treatment at session 20.

• Perceived benefit of skills training in DBT-A measured by a study specific questionnaire.

  At dropout at any time between session 1 and end of treatment at session 20, or for completers after 20 weeks DBT-A ("post"),

Study Arms (1)

DBT-A

EXPERIMENTAL

Single group uncontrolled study. All participants will receive DBT-A

Behavioral: Dialectical behavior therapy for adolescents (DBT-A)

Interventions

Dialectical behavior therapy for adolescents (DBT-A) BEHAVIORAL

A 20-week DBT-A with a weekly individual session (45 minutes), a weekly session of multifamily skills training groups with a caregiver (120 minutes), and telephone consultation with individual therapists outside therapy sessions as needed. The treatment consists of four components and is delivered according to the manual except for the phone coaching that PBU offers workdays until 8 pm.

Also known as: DBT-A

DBT-A

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Dept. of child and adolescent psychiatry, Haukeland University Hospital

Bergen, Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Suicide

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gro Janne H. Wergeland, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gro Janne H. Wergeland, MD, PhD

CONTACT

+47 48176828; gneh@helse-bergen.no

Anne Mari Syversen, Psychol

CONTACT

+47 55975000; anne.mari.syversen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An independent evaluator will assess participants at post treatment and one year follow-up. Due to the single group design, the assessor will be aware that participants have received the intervention, but will not be involved in recruitment and treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, uncontrolled, pre-post-one year follow-up study

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 18, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)