Predictors of Clinical Course and Treatment Response in Patients Having Received Dialectical Behaviour Therapy Delivered by Clinical Units in the Norwegian Network for Clinical Evaluation and Quality in DBT Programmes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Suicidal Ideation (adults)
研究概览
简要总结
The project is a collaboration between The National Centre for Suicide Research and Prevention (NSSF) and clinical units with Dialectical Behaviour Therapy (DBT) programmes. A methodological and technological platform has been established that enables clinicians to deliver high quality treatments over extended periods of time, to evaluate their own performance and productivity and to report it in a uniform and systematic way that will enable comparison across clinical settings and programmes. The collected data constitute the basis for conducting the clinical study with the overall aim to study predictors of the clinical course and treatment response in patients admitted to DBT programmes in Norway.
详细描述
The aim of the project is to collect data from systematic and uniform clinical assessments to study predictors of the clinical course and treatment response in patients admitted to and treated in clinical units delivering Dialectical Behaviour Therapy in Norway.
Aims and research questions:
The study will address the following main research questions:
- Which patient characteristics (sociodemographic variables, psychiatric diagnoses/comorbidities, previous suicidal and self-harming behaviour, previous treatment history), predict a favourable clinical course and treatment response?
- Which factors mediate the clinical change in key outcomes such as a) target symptom levels (depression, hopelessness, suicidal ideation, borderline symptoms etc.), b) function levels (emotion regulation capacity, use of coping skills, social functioning, occupational / academic performance level etc.), c) problem behaviours (suicide attempts, non-suicidal self-harm, substance abuse, eating disorder symptoms etc.), d) global functioning and e) the use of emergency treatment services.
- What are significant moderators of treatment response with respect to key clinical outcomes (mentioned above)?
- Which of the treatment modalities are evaluated as the most salient and helpful by patients who receive the treatment according to their age, gender, psychiatric diagnoses and previous treatment history?
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of repeated deliberate self harm
- •Satisfies criteria of Diagnostic and Statistical Manual (DSM-IV) Borderline Personality Disorder as measured by Structured Clinical Interview for the DSM (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
Suicidal Ideation (adults)
时间窗: 4 weeks
Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome
Depressive symptoms (adolescents)
时间窗: 1 week
Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome
Self-harm behaviour
时间窗: 4 weeks
Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)
Suicidal Ideation (adolescents)
时间窗: 2 weeks
Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome
Depressive symptoms
时间窗: 1 week
MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome
Depressive symptoms (adults)
时间窗: 1 week
Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome
次要结局
- Borderline Symptoms(1 week)
- Hopelessness(1 week)
研究者
Lars Mehlum
Professor dr med
Oslo University Hospital