NCT04298190

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

March 4, 2020

Last Update Submit

October 31, 2023

Conditions

Self-Harm, DeliberateBorderline Personality Disorder

Keywords

self harmdialectical behaviour therapyborderline personality disorderemotional dysregulation

Outcome Measures

Primary Outcomes (1)

  • Frequency of subsequent episodes of self-harm

    Measured by the Linehan Parasuicide Count (LPC)

    10 years

Secondary Outcomes (4)

  • Severity of suicidal ideation

    10 years

  • Self-reported evel of depressive symptoms

    10 years

  • Researcher rated level of depressive symptoms

    10 years

  • Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour

    10 years

Study Arms (2)

Dialectical Behaviour Therapy

EXPERIMENTAL

Dialectical Behavior Therapy, delivered for 19 weeks, consisted of 1 weekly session of individual therapy (60 minutes), 1 weekly session of multifamily skills training (120 minutes), and family therapy sessions and Telephone coaching with individual therapists outside therapy sessions as needed.

Behavioral: Dialectical Behaviour Therapy for Adolescents (DBT-A)

Enhanced Usual Care

ACTIVE COMPARATOR

Enhanced usual care was 19 weeks of standard care (enhanced for the purpose of the study by requiring that EUC therapists agree to provide on average no less than 1 weekly treatment session per patient throughout the trial) delivered by therapists (4 psychiatrists, 16 clinical psychologists, 6 clinical social workers, 2 clinical pedagogues, 1 specialist nurse, and 1 psychology graduate student) not trained in or practicing DBT.

Behavioral: Enhanced usual care

Interventions

Dialectical Behaviour Therapy for Adolescents (DBT-A)BEHAVIORAL

16 weeks of Dialectical behavior therapy with one weekly session of individual therapy, one weekly session of multifamily skills training group, telephone coaching and ancillary family therapy and/or pharmacological treatment as needed. The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus \& Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively.

Dialectical Behaviour Therapy
Enhanced usual careBEHAVIORAL

16 weeks of outpatient treatment in child and adolescent psychiatric clinics in Oslo, on average one weekly session of individual therapy and ancillary supportive family and/or pharmacological treatment as needed.

Enhanced Usual Care

Eligibility Criteria

Age22 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of repeated self-harm (last episode within last 4 months) and
  • Age between 12 and 18 years and
  • Satisfied at least 2 criteria of DSM-IV Borderline Personality Disorder (BPD) (as measured by the SCIDII) (in addition to the self-destructive criterion) - alternatively at least 1 criterion of DSM-IV BPD plus at least 2 threshold level criteria and
  • Written informed consent from patient and parent(s) to participate in the study and
  • Patient fluently Norwegian speaking

You may not qualify if:

  • Psychotic disorders or
  • Anorexia nervosa or
  • Severe substance dependence disorders or
  • Mental retardation (IQ less than 70) or
  • Asperger syndrome/autism -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Centre for Suicide Research and Prevention Unit/University of Oslo

Oslo, 0372, Norway

Location

Related Publications (4)

  • Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press

    BACKGROUND

  • Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press

    BACKGROUND

  • Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press

    BACKGROUND

  • Mehlum L, Dibaj IS, Haga E, Helle SE, Morken KTE, Klungsoyr O, Tormoen AJ. Adult life outcomes for adolescents 12.4 years after dialectical behavior therapy - a randomized clinical trial. Eur Child Adolesc Psychiatry. 2026 Jan 16. doi: 10.1007/s00787-025-02856-w. Online ahead of print.

    PMID: 41543545DERIVED

Related Links

MeSH Terms

Conditions

Self-Injurious BehaviorBorderline Personality Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lars Mehlum, MD PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor dr med

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

May 15, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)