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

Borderline Personality Disorder Clinical Trial

Official title:

Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. Outcomes in Adult Life 10 Years Posttreatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298190
• Other study ID #: ES641048
• Status: Completed
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Suicide attempts and non-suicidal self-harm, highly prevalent in adolescents, are behaviours strongly associated with severe emotion dysregulation, mental health problems and increased suicide risk. The original study, on which the present study is building, used a randomized controlled design, with a stratified block randomization procedure, and blinded pre-treatment, post-treatment and follow-up evaluations comparing 19weeks of DBT-A with EUC of equal length.

Of special interest to this follow-up study is to gain more knowledge on their capacity to regulate emotions, since failures in emotion regulation is an underlying mechanism of repetitive self-harm behaviours and several other difficulties, and since a main aim of DBT-A is to enhance adolescents capacity to use healthy emotion regulation strategies. The study is designed to carefully include user and family perspectives on the definition of specific outcomes and how to measure them, we will collect detailed data on important outcomes employing a combination of quantitative and qualitative methods, innovative approaches such as ecological momentary assessment and register data. Adding new data to the existing rich data will give us a basis to study the dynamic interplay between symptoms, emotions, and functional and dysfunctional behaviours and make new discoveries of mechanisms of therapeutic change, knowledge to further increase treatment response rates and individualize treatments and to inform further development of this treatment and its implementation in Norway and other countries.

The proposed study will investigate:

1. the 10-year post-randomization treatment outcomes of DBT-A compared with EUC with respect to: a) frequency of subsequent episodes of self-harm, b) severity of suicidal ideation, c) level of depressive symptoms and d) frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour.

2. the 10-year post-randomization clinical course and stability of a diagnosis of BPD, its diagnostic criteria and borderline symptoms.

3. participants' adult mental health, social, family and occupational functioning and quality of life.

4. participants' adult strategies for and capacity to cope with stressful life-events and situations in their daily lives and effectively regulate emotions.

5. the association between participants' adult life use of skills and functional coping strategies and self-harm behaviour and other problem behaviours, and whether any substitution from onedysfunctional coping behaviour to another has occurred.

6. participants' evaluation of what components of the treatment was most helpful and led to the strongest and most persistent change in important functions and aspects of life.

7. the economic cost of treatments consumed and functional impairment and occupational disability over the 10-year post-randomization period and the long-term cost-effectiveness of DBT-A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 30 Years

Eligibility

The inclusion criteria for the initial study were:

1. History of repeated self-harm (last episode within last 4 months) and

2. Age between 12 and 18 years and

3. 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

4. Written informed consent from patient and parent(s) to participate in the study and

5. Patient fluently Norwegian speaking

Exclusion Criteria:

1. Psychotic disorders or

2. Anorexia nervosa or

3. Severe substance dependence disorders or

4. Mental retardation (IQ less than 70) or

5. Asperger syndrome/autism -

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Self-Harm, Deliberate
• Self-Injurious Behavior

Intervention

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

Locations

Country	Name	City	State
Norway	National Centre for Suicide Research and Prevention Unit/University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of subsequent episodes of self-harm	Measured by the Linehan Parasuicide Count (LPC)	10 years
Secondary	Severity of suicidal ideation	Measured by the Suicidal Ideation Questionnaire Jr (SIQ-Jr). Scale range: min= 0, max = 90. High values represent a worse outcome.	10 years
Secondary	Self-reported evel of depressive symptoms	Measured by the Moods and feelings questionnaire (MFQ). Scale range: min = 0, max = 26. High levels represent a worse outcome	10 years
Secondary	Researcher rated level of depressive symptoms	Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale range: min=0, max=60. High levels represent a worse outcome	10 years
Secondary	Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour	Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register	10 years

External Links

•   Information about the research project in Norwegian