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

Primary Purpose

Self-Harm, Deliberate, Borderline Personality Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dialectical Behaviour Therapy for Adolescents (DBT-A)
Enhanced usual care
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-Harm, Deliberate focused on measuring self harm, dialectical behaviour therapy, borderline personality disorder, emotional dysregulation

Eligibility Criteria

22 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dialectical Behaviour Therapy

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of subsequent episodes of self-harm
Measured by the Linehan Parasuicide Count (LPC)

Secondary Outcome Measures

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.
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
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
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

Full Information

First Posted
March 4, 2020
Last Updated
September 20, 2022
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT04298190
Brief Title
Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. 10 Year Follow-up
Official Title
Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. Outcomes in Adult Life 10 Years Posttreatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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: 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. the 10-year post-randomization clinical course and stability of a diagnosis of BPD, its diagnostic criteria and borderline symptoms. participants' adult mental health, social, family and occupational functioning and quality of life. participants' adult strategies for and capacity to cope with stressful life-events and situations in their daily lives and effectively regulate emotions. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Harm, Deliberate, Borderline Personality Disorder
Keywords
self harm, dialectical behaviour therapy, borderline personality disorder, emotional dysregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dialectical Behaviour Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behaviour Therapy for Adolescents (DBT-A)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of subsequent episodes of self-harm
Description
Measured by the Linehan Parasuicide Count (LPC)
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Severity of suicidal ideation
Description
Measured by the Suicidal Ideation Questionnaire Jr (SIQ-Jr). Scale range: min= 0, max = 90. High values represent a worse outcome.
Time Frame
10 years
Title
Self-reported evel of depressive symptoms
Description
Measured by the Moods and feelings questionnaire (MFQ). Scale range: min = 0, max = 26. High levels represent a worse outcome
Time Frame
10 years
Title
Researcher rated level of depressive symptoms
Description
Measured by the Montgomery Asberg Depression Rating Scale (MADRS). Scale range: min=0, max=60. High levels represent a worse outcome
Time Frame
10 years
Title
Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of self-harm behaviour
Description
Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria for the initial study were: 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 Exclusion Criteria: Psychotic disorders or Anorexia nervosa or Severe substance dependence disorders or Mental retardation (IQ less than 70) or Asperger syndrome/autism -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Mehlum, MD PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Centre for Suicide Research and Prevention Unit/University of Oslo
City
Oslo
ZIP/Postal Code
0372
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Linehan, M.M. (1993a). Cognitive-behavioral treatment of borderline personality disorder. New York: Guilford Press
Results Reference
background
Citation
Linehan, M.M. (1993b). Skills training manual for treating borderline personality disorder. New York: Guilford Press
Results Reference
background
Citation
Miller, A.L., Rathus J.H., Linehan, M.M. (2007). Dialectical behavioral therapy with suicidal adolescents. New York: Guilford Press
Results Reference
background
Links:
URL
http://www.med.uio.no/klinmed/forskning/sentre/nssf/forskning/nssf-prosjekter/dbt-langtidseffekt/
Description
Information about the research project in Norwegian

Learn more about this trial

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

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