Wise Eating: A Guided Digital DBT-Based Intervention for Binge Eating-A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- BES, Binge Eating Scale
研究概览
简要总结
Bulimia Nervosa (BN), characterized by binge eating and purging behaviors, constitutes a chronic psychiatric disorder predominantly affecting young females, characterized by high prevalence and relapse rates. Its core features include recurrent binge-eating episodes accompanied by compensatory behaviors such as self-induced vomiting and laxative misuse, resulting in significant impairment to patients' physiological, psychological, and social functioning. Recent epidemiological trends in China indicate a rising BN incidence, with suspected prevalence rates reaching 4.7%-17% among secondary and tertiary education cohorts.
Nevertheless, current treatment modalities present substantial concerns. Despite established evidence-based clinical practice guidelines, merely 25% of affected individuals receive appropriate intervention. Multiple systemic barriers impede care access, including: (1) scarcity of adequately trained clinicians; (2) patient-endorsed stigma and apprehension regarding eating disorders (EDs); (3) geographical constraints; (4) financial burdens associated with in-person therapy; and (5) insufficient treatment-seeking motivation.
The proliferation of mobile technologies has positioned mHealth as a viable solution to expand patient coverage. This modality offers self-diagnostic, monitoring, and therapeutic opportunities for populations with limited access to traditional care, while simultaneously mitigating treatment-related stigmatization. Consequently, this project investigates the efficacy of a Dialectical Behavior Therapy (DBT)-based self-help system for binge-eating behaviors. Employing a randomized controlled trial (RCT) design, BN patients will be allocated to intervention and control groups. Comparative analysis of clinical psychological metrics will be conducted at baseline, 2-week, 4-week, and 8-week intervals post-intervention, with feasibility assessed through structured interviews. This research aims to establish an effective, low-cost remote self-help intervention to enhance treatment accessibility and therapeutic outcomes for BN patients.
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 (Participant, Investigator)
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
- •Participants must fulfill all following conditions:
- •(i) Aged ≥18 years; (ii) Proficient in operating WeChat-enabled smartphones; (iii) Exhibit binge-eating behaviors: ≥4 binge-eating episodes within the preceding 28-day period; (iv) If receiving psychotropic medication: stable dosing regimen maintained for ≥1 month prior to enrollment, with no planned dosage adjustments during the trial period; concurrent psychotherapy is exclusionary; (v) Absence of structured nutritional therapy or formal psychological interventions within 30 days preceding enrollment; (vi) Demonstrated comprehension of the study protocol and provision of written informed consent.
排除标准
- •(i) Severe anxiety or depressive symptom. (ii) Investigator-determined contraindications to trial participation based on clinical assessment.
研究组 & 干预措施
Digital DBT group
干预措施: online dialectical behavior therapy (Behavioral)
Waitlist control
waitlist patient is provided with psychoeducation
干预措施: Waitlist and psychoeducation (Behavioral)
结局指标
主要结局
BES, Binge Eating Scale
时间窗: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment
次要结局
- GAD, Generalized Anxiety Disorder 7-item scale(Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment)
- BIS, Barratt Impulsiveness Scale(Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment)
- EDE-Q, Eating Disorder Examination Questionnaire(Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment)
- DERS, Difficulties in Emotion Regulation Scale(Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment)
- PHQ, Patient Health Questionnaire(Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment)