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

Primary Purpose

Intentional Self Harm

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dialectical behavior therapy
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 Intentional Self Harm

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients included in the initial RCT 'Treatment for Adolescents With Deliberate Self Harm' (ClinicalTrials ID NCT00675129). Inclusion criteria for this study were:

  • 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.

Exclusion Criteria:

  • Psychotic disorders
  • Anorexia Nervosa
  • Substance dependence disorder
  • Mental retardation (IQ less than 70)
  • 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 behavior 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 deliberate self harm and time elapsed to future episodes of deliberate 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.
Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior
Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register
Self reported level 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 through the Montgomery Asberg Depression Rating Scale (MADRS). Scale range: min = 0, max = 60. High levels represent a worse outcome.

Full Information

First Posted
April 16, 2012
Last Updated
April 18, 2022
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01593202
Brief Title
Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours
Official Title
Long Term Efficacy of Dialectical Behaviour Therapy vs Enhanced Usual Care for Adolescents With Self-Harming and Suicidal Behaviours
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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 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.
Detailed Description
The study is a long-term follow-up of a randomized trial comparing DBT-A with enhanced usual care (EUC). Participants were randomly allocated to receive either treatment at 1 of the participating child and adolescent psychiatric outpatient clinics in a 1:1 ratio stratified according to gender, presence of major depression, and presence of suicide intent during the most serious episode of self-harm behavior within the 16 weeks before enrollment. Treatment allocation of participants after baseline assessments was based on a permuted block randomization procedure with an undisclosed and variable blocking factor, and daily management of the randomization procedures was performed by an external group. Patients received either DBT or EUC by therapists working at and funded by the 10 child and adolescent psychiatric outpatient clinics participating in the study. They were assessed during treatment (9 and 15 weeks), at treatment completion 19 weeks, and at 71 weeks. In this study they are assessed at 2 years after treatment completion. The assessment of outcomes include: number of self-reported self-harm episodes (suicide attempts and non-suicidal self-harm episodes combined, measured by Lifetime Parasucide Count); the severity of suicidal ideation as measured by the 15-item self-report Suicidal Ideation Questionnaire (SIQ-JR; and level of depressive symptoms as measured by the 13-item version of the self-report Short Mood and Feelings Questionnaire (SMFQ) and through the interviewer rated 10-item Montgomery-_Asberg Depression Rating Scale (MADRS). Other outcomes are hopelessness, measured by the 20-item self-report Beck Hopelessness Scale (BHS);borderline symptoms, assessed through the 23-itemself-report Borderline Symptom List (BSL); Borderline Personality Disorder as measured by SCID-II; and hospital admissions and emergency department visits because of self-harm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intentional Self Harm

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dialectical behavior 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 behavior therapy
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 deliberate self harm and time elapsed to future episodes of deliberate self harm
Description
Measured by the Linehan Parasuicide Count (LPC)
Time Frame
2 years after end of treatment
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
2 years
Title
Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior
Description
Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register
Time Frame
2 years
Title
Self reported level 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
2 years
Title
Researcher rated level of depressive symptoms
Description
Measured through the Montgomery Asberg Depression Rating Scale (MADRS). Scale range: min = 0, max = 60. High levels represent a worse outcome.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients included in the initial RCT 'Treatment for Adolescents With Deliberate Self Harm' (ClinicalTrials ID NCT00675129). Inclusion criteria for this study were: 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. Exclusion Criteria: Psychotic disorders Anorexia Nervosa Substance dependence disorder Mental retardation (IQ less than 70) Asperger syndrome/autism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Mehlum, Professor
Organizational Affiliation
National Centre for Suicide Research and Prevention
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:
PubMed Identifier
31127612
Citation
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.
Results Reference
derived
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

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

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