Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours (NCT01593202) | Clinical Trial Compass
CompletedNot Applicable
Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours
Norway77 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range
13 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm