Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours

NCT01593202 | Completed

• 1 other identifier: ES4894
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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 five different time-points: baseline (before starting treatment), 9 weeks, 15 weeks, 19 weeks and 71 weeks after start of the treatment. In the current project patients will be assessed a 6th time 2 years after treatment completion. The main study hypotheses are:

• DBT will be significantly more efficacious in reducing the number of self-harm episodes with or without intent to die, as well as reducing the number of emergency room visits for self-harm or suicidal behaviour, compared to EUC.
• DBT will be significantly more efficacious in reducing the level of suicidal ideation and depressive symptoms compared to EUC.

Conditions

Intentional Self Harm

Outcome Measures

Primary Outcomes (1)

• Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm

  Measured by the Linehan Parasuicide Count (LPC)

  2 years after end of treatment

Secondary Outcomes (4)

• Severity of suicidal ideation

  2 years

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

  2 years

• Self reported level of depressive symptoms

  2 years

• Researcher rated level of depressive symptoms

  2 years

Study Arms (2)

Dialectical behavior 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 behavior therapy

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 behavior therapy 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 behavior therapy

Enhanced usual care BEHAVIORAL

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

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of repeated deliberate self harm (last episode within last months)
• Satisfies at least 2 criteria of DSM-IV Borderline Personality Disorder (as measured by SCID-II) in addition to the self-destructive criterion.
• Or: Satisfies at least 1 criterion + 2 criteria scored below threshold (score 2) of DSM-IV Borderline Personality Disorder (as measured by SCID-II) in addition to the self-destructive criterion.

You may not qualify if:

• Psychotic disorders
• Anorexia Nervosa
• Substance dependence disorder
• Mental retardation (IQ less than 70)
• Asperger syndrome/autism

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

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

Oslo, 0372, Norway

Location

Related Publications (1)

• Mehlum L, Ramleth RK, Tormoen AJ, Haga E, Diep LM, Stanley BH, Miller AL, Larsson B, Sund AM, Groholt B. Long term effectiveness of dialectical behavior therapy versus enhanced usual care for adolescents with self-harming and suicidal behavior. J Child Psychol Psychiatry. 2019 Oct;60(10):1112-1122. doi: 10.1111/jcpp.13077. Epub 2019 May 25.

  PMID: 31127612 DERIVED

Related Links

• Information about the research project in Norwegian

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lars Mehlum, Professor

  National Centre for Suicide Research and Prevention

  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

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: May 8, 2012
• Study Start: January 1, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)