Efficacy of Cognitive-behavioral Therapy (CBT) and Digital Therapy (DT) in the Prevention of Suicide Risk in Patients With Eating Disorders (ED): a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score.
研究概览
简要总结
The purpose of this study is to determine if adding a digital intervention to standard cognitive-behavioral therapy (CBT) is more effective in preventing suicide risk and reducing eating disorder symptoms. Participants will be women between 18 and 65 years old who have recently experienced suicidal ideation or attempts. One group will receive standard group therapy, while the other will receive group therapy plus a mobile application and digital monitoring devices. The goal is to see if digital tools can improve clinical outcomes and safety for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gender: Female.
- •Age between 18 and 65 years old.
- •Clinically stable and able to provide written informed consent.
- •Subjects included in the "Suicide Risk Code" (Codi Risc Suïcidi - CRS) program due to recent suicidal ideation or suicide attempts.
- •Patients with a diagnosis of an Eating Disorder (ED).
排除标准
- •Presence of intellectual disability or cognitive impairment that prevents understanding the therapy or the study requirements.
- •Diagnosis of Bipolar Disorder or any Psychotic Disorder.
- •Current active substance abuse or dependence.
- •Any medical condition that, in the investigator's opinion, makes participation unsafe or unfeasible.
研究组 & 干预措施
Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT)
干预措施: Cognitive Behavioural Therapy (CBT) + Digital Therapy (DT) (Behavioral)
Cognitive Behavioural Therapy (CBT)
干预措施: Cognitive Behavioural Therapy (CBT) (Behavioral)
结局指标
主要结局
Change from Baseline in Eating Attitudes Test-26 (EAT-26) Score.
时间窗: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
The EAT-26 is a self-report questionnaire used to assess eating disorder risk and symptoms. It consists of 26 items. Total scores range from 0 to 78, where higher scores indicate greater severity of eating disorder symptoms.
Change from Baseline in Bulimic Investigatory Test Edinburgh (BITE) Score.
时间窗: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
The BITE is used to identify individuals with binge-eating and compensatory behaviors. It consists of two subscales: Symptoms (0-30 points) and Severity (0-39 points). We will report the Total Score. Higher scores indicate higher levels of bulimic symptoms.
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score.
时间窗: Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.
The C-SSRS Full Scale is a clinical tool used to assess the full spectrum of suicidal ideation and behavior. It consists of two main sections: (1) Suicidal Ideation (A severity scale ranging from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent) and (2) Suicidal Behavior (A scale that tracks the presence of actual, interrupted, or aborted attempts, and preparatory acts rated as Yes/No). For this outcome, we will report the Suicidal Ideation Severity Score. Higher scores indicate a greater severity of suicidal ideation.
次要结局
- Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score.(Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.)
- Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score.(Baseline (Week 0), End of treatment (Week 8), 6-month follow-up, and 12-month follow-up.)
研究者
Aleix Jorba Chacón
Clinical psychologist
Universitat Autonoma de Barcelona