Emotional Dysregulation and Maladaptive Overcontrol in Anorexia Nervosa and the Effect of Radically Open Dialectical Behaviour Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The Eating Disorder Examination Questionnaire (EDE-Q)
研究概览
简要总结
This clinical trial employs a two-fold approach, utilizing a single-arm feasibility design within a larger multiple baseline experimental case series study framework over 32 weeks. The study aims to investigate both the feasibility and efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in patients with anorexia nervosa (AN). Feasibility will be assessed through treatment retention, data collection engagement, patient satisfaction, and the occurrence of adverse events. Efficacy outcomes will focus on RO-DBT's impact on ED psychopathology, obsessive-compulsive personality traits, EDR, and BMI.
详细描述
Anorexia nervosa (AN) is characterized by high chronicity and mortality rates. Despite its relatively high prevalence, effective treatments remain elusive, often resulting in extended treatment durations and high dropout rates. Emotional dysregulation (EDR) and obsessive-compulsive personality traits are central to the psychopathology of AN, directly contributing to the disorder's severity and persistence. Radically Open Dialectical Behaviour Therapy (RO-DBT) targets the psychopathology mentioned above and has shown promise in pilot studies with AN patients.
Given the urgent need for effective AN treatments and the potential of RO-DBT, this study aims to investigate both the feasibility and efficacy of this therapy in a clinical setting. The study will employ a single-arm feasibility design within a multiple baseline experimental case series framework over 32 weeks, involving 31 patients aged 16 years and older diagnosed with typical or atypical AN. All assessments will utilize validated psychometric instruments, and trained psychotherapists will administer RO-DBT.
Feasibility will be assessed through:
- Treatment retention
- Data collection engagement
- Patient satisfaction with treatment
- Occurrence of adverse events.
The primary efficacy outcome this trial aims to investigate is:
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of anorexia nervosa or atypical nervosa (i.e., in partial remission with a BMI above ~18.5 but meets criteria B and/or C) according to the Diagnostic and Statistical Manual fifth edition (DSM-5)
- •Signed written informed consent form
- •Age 16-65
- •Sufficient knowledge of Swedish
排除标准
- •Substance dependence
- •Not willing to accept randomization
- •Undergoing simultaneous psychotherapy via another healthcare provider
- •Intellectual disability
- •Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.
结局指标
主要结局
The Eating Disorder Examination Questionnaire (EDE-Q)
时间窗: 32 weeks
A 36-item self-report questionnaire designed to measure eating disorder symptoms. The range of scores is 0-132. Higher scores mean more eating disorder symptoms
次要结局
- The Five Factor Obsessive Compulsive Inventory - Short Form (FFOCI-SF)(32 weeks)
- The Emotion Regulation Questionnaire (ERQ)(32 weeks)
- Body mass index (BMI)(32 weeks)
- Client Satisfaction Questionnaire (CSQ-8)(32 weeks)