Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Changes in Emotion Regulation Difficulties
研究概览
简要总结
This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks.
The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.
详细描述
Background:
Emotion regulation is pivotal in the pathogenesis and persistence of diverse psychopathologies. While anxiety disorders are often marked by an impaired ability to modulate acute fear responses, depressive disorders feature enduring negative affect and frequent rumination. In eating disorders, emotional dysregulation typically leads to maladaptive coping via disordered eating behaviors, whereas in borderline personality disorder, it manifests as emotional instability. The pervasiveness of emotion regulation difficulties across these diverse clinical presentations highlights a need for treatments targeting this shared mechanism. Our study aims to address this gap by testing the effectiveness of a novel web-based emotion regulation intervention in a transdiagnostic sample.
Method:
This two-armed randomized controlled trial involves participants aged 18 and above diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without psychiatric diagnoses. Participants will be randomly assigned to one of two groups:
- Web-based emotion regulation intervention.
- Waitlist control group with delayed intervention access (eight weeks).
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Clinical interviews and data analysis will be conducted blindly.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sufficient German language skills (C1)
- •Permanent internet access during the study period
- •≥ 18 years of age
排除标准
- •Acute suicidality
- •Current severe substance use disorder
- •Current severe depressive episode
- •Lifetime bipolar disorder
- •Lifetime psychotic disorders
- •Body Mass Index (BMI) below 18.5
研究组 & 干预措施
Intervention group
Web-based emotion regulation intervention
干预措施: Heidelberg Emotion Regulation Training (Behavioral)
Waitlist control group
Eight-week waiting period
结局指标
主要结局
Changes in Emotion Regulation Difficulties
时间窗: 0 weeks, 4 weeks, 8 weeks
The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)
次要结局
- Changes in Eating-Disorder-Related Daily Difficulties(0 weeks, 4 weeks, 8 weeks)
- Changes in Weekly Emotion Regulation Strategy Use(0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks)
- Changes in Anxiety Symptoms(0 weeks, 4 weeks, 8 weeks)
- Changes in Eating Psychopathology(0 weeks, 4 weeks, 8 weeks)
- Changes in Personality Pathology(0 weeks, 4 weeks, 8 weeks)
- Changes in Self-Esteem(0 weeks, 4 weeks, 8 weeks)
- Changes in Emotion Regulation Strategy Use(0 weeks, 4 weeks, 8 weeks)
- Changes in Well-Being(0 weeks, 4 weeks, 8 weeks)
- Changes in Depressive Symptoms(0 weeks, 4 weeks, 8 weeks)
- Changes in Weekly Eating Psychopathology(0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks)
- Changes in Weekly Positive and Negative Affect(0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks)
研究者
Luise Pruessner
Principal Investigator
Heidelberg University