Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours
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Purpose
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 80 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), 6 weeks, 12 weeks, 16 weeks and 68 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intentional Self Harm |
Behavioral: Dialectical behavior therapy Behavioral: Enhanced usual care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Long Term Efficacy of Dialectical Behaviour Therapy vs Enhanced Usual Care for Adolescents With Self-Harming and Suicidal Behaviours |
- Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm [ Time Frame: 2 years after end of treatment ] [ Designated as safety issue: Yes ]
- Severity of suicidal ideation, level of depressive symptoms [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | September 2022 |
| Estimated Primary Completion Date: | September 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dialectical behavior therapy |
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. |
| Active Comparator: Enhanced usual care |
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 13 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lars Mehlum, MD PhD | 0047-22923473 | lars.mehlum@medisin.uio.no |
| Contact: Egil Haga, PhD | 0047-22923442 | egil.haga@medisin.uio.no |
| Norway | |
| National Centre for Suicide Research and Prevention Unit/University of Oslo | Recruiting |
| Oslo, Norway, 0372 | |
| Contact: Lars Mehlum, MD PhD 0047-22923473 lars.mehlum@medisin.uio.no | |
| Contact: Egil Haga, PhD 0047-22923442 egil.haga@medisin.uio.no | |
| Principal Investigator: | Lars Mehlum, Professor | National Centre for Suicide Research and Prevention |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lars Mehlum, Professor, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01593202 History of Changes |
| Other Study ID Numbers: | ES4894 |
| Study First Received: | April 16, 2012 |
| Last Updated: | December 5, 2012 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
ClinicalTrials.gov processed this record on May 16, 2013