NCT04298190

Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. 10 Year Follow-up

Completed NA Last updated 1 November 2023

What this trial tests

NA trial testing Dialectical Behaviour Therapy for Adolescents (DBT-A) in Self-Harm, Deliberate in 61 participants. Completed in 30 April 2023.

Timeline

15 May 2022

Primary endpoint
30 April 2023

30 April 2023

Quick facts

Lead sponsor	Oslo University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	61
Start date	15 May 2022
Primary completion	30 April 2023
Estimated completion	30 April 2023
Sites	1 location across Norway

Drugs / interventions tested

• Dialectical Behaviour Therapy for Adolescents (DBT-A)
• Enhanced usual care

Conditions studied

• Self-Harm, Deliberate — all drugs for Self-Harm, Deliberate →
• Borderline Personality Disorder — all drugs for Borderline Personality Disorder →

Sponsor

Oslo University Hospital

Who can join

Adults 22 to 30, any sex, with Self-Harm, Deliberate or Borderline Personality Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the long-term efficacy of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have been assessed so far on six different time-points: baseline (before starting treatment), 9 weeks, 15 weeks, 19 weeks, 71 weeks and 3 years after start of the treatment. In the current project patients will be assessed a 7th time 10 years after treatment completion.

It is hypothesized that compared with participants who had received EUC in the original trial during their adolescence participants who had received DBT-A will:

A) report a significantly lower frequency of episodes of self-harm, both last year and over the extended 10-year follow-up interval.

B) be significantly less impaired with respect to social, family and occupational functioning and report a higher quality of life.

C) have retained significantly fewer diagnostic criteria of BPD and have less severe borderline features according to dimensional measures and have significantly fewer signs of emotion dysregulation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adult life outcomes for adolescents 12.4 years after dialectical behavior therapy - a randomized clinical trial.
   Mehlum L, Dibaj IS, Haga E, Helle SE, et al · · 2026 · cited 1× · PMID 41543545 · DOI 10.1007/s00787-025-02856-w