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

Intentional Self Harm Clinical Trial

Official title:

Long Term Efficacy of Dialectical Behaviour Therapy vs Enhanced Usual Care for Adolescents With Self-Harming and Suicidal Behaviours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593202
• Other study ID #: ES4894
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 31, 2022

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Intentional Self Harm
• Self-Injurious Behavior

Intervention

Behavioral:
• Dialectical behavior therapy
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 (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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.	2 years

External Links

•   Information about the research project in Norwegian