National Centre for Suicide Research and Prevention Unit/University of Oslo
Oslo, 0372, Norway
NCT Number: NCT04298190
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.
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Notify Me22 year–30 year
All sexes
Interventional
Not applicable
Oslo, 0372, Norway
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria for the initial study were:
Exclusion criteria
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.
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.
Time frame: 10 years
Measured by the Linehan Parasuicide Count (LPC)
Time frame: 10 years
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
Measured by the Moods and feelings questionnaire (MFQ). Scale range: min = 0, max = 26. High levels represent a worse outcome
Time frame: 10 years
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
Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register
Oslo University Hospital
Other
Dialectical Behavior Therapy vs Enhanced Usual Care for Suicidal and Self-harming Adolescents. Outcomes in Adult Life 10 Years Posttreatment
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