A Randomized Controlled Trial for Repetitive Deliberate Self-harm and Suicidal Behaviours Among Norwegian Adolescents: a Comparison Between Dialectical Behaviour Therapy Adapted for Adolescents (DBT-A) and Enhanced Usual Care (EUC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Severity of suicidal ideation, level of depressive symptoms
研究概览
简要总结
The purpose of the study is to evaluate the efficiency of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to Enhanced Usual Care (EUC). Eighty patients in the age of 12-18 yrs old will be included in the study. The main inclusion criterion is repetitive deliberate self-harm. The patients will receive 16 weeks treatment in outpatient clinics in Oslo, after having been randomized to DBT or EUC. They will be assessed on five different time-points: baseline (before starting treatment), 6 weeks (after start of treatment), 12 weeks, 16 weeks and 68 weeks.
The main study hypothesis is:
- DBT will be significantly more effective in treatment of self-harm behavior, as measured/indicated by reduction in number of self-harm episodes with or without intent to die, as well as reduction of number of emergency room visits.
- It is also hypothesized that DBT will significantly reduce the level of suicidal ideation and depressive symptoms compared to EUC.
详细描述
Power analysis:
Exact data on the repetition of self-harm over 16-20 week and 12 months observation periods for adolescents in outpatient psychiatric treatment are not available. Building on previous clinical studies and RCT studies in adults receiving DBT, we anticipate that the 16 week repetition rate will be 50% for adolescents who receive EUC and 25% for adolescents who receive DBT. With an alpha error level of 5% 60 patients in each group is needed to provide 80% power with a two tailed test. We anticipate a drop out rate from research assessments of no more than 25%. To compensate for this attrition, it is calculated that 15 patients in each treatment group should be added, leading to a total number of 150 patients to be included in the trial. A more precise power analysis and determination of how many patients to include in the study will be based on data from the first 40 patients who have been included.
A power analysis conducted on the basis of the first 40 patients showed that:
- There had been no attrition from research assessments
- With an alpha error level of 5% 40 patients in each group is needed to provide 80% power with a two tailed test
A final number of patients to include was therefore fixed at 80.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Psychotic disorders
- •Anorexia Nervosa
- •Substance dependence disorder
- •Mental retardation (IQ less than 70)
- •Asperger syndrome/autism
结局指标
主要结局
Severity of suicidal ideation, level of depressive symptoms
时间窗: 16 weeks and 68 weeks
Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm
时间窗: 16 weeks and 68 weeks
次要结局
- Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior(16 weeks and 68 weeks)
研究者
Lars Mehlum
Professor
Oslo University Hospital