Clinical trial NCT01593202: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intentional Self Harm
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 77
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm
timeFrame: 2 years after end of treatment
Secondary outcomes:
measure: Severity of suicidal ideation
timeFrame: 2 years
measure: Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior
timeFrame: 2 years
measure: Self reported level of depressive symptoms
timeFrame: 2 years
measure: Researcher rated level of depressive symptoms
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: National Centre for Suicide Research and Prevention Unit/University of Oslo
Study officials:
affiliation: National Centre for Suicide Research and Prevention
name: Lars Mehlum, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.