Wise Eating: A Guided Digital DBT-Based Intervention for Binge Eating
- Conditions
- Bulimia NervosaBinge Eating BehaviourAnorexia NervosaEating Disorders
- Registration Number
- NCT07143214
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
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.
(i) Severe anxiety or depressive symptom. (ii) Investigator-determined contraindications to trial participation based on clinical assessment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method BES, Binge Eating 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai Municipality, China
Shanghai Mental Health Center🇨🇳Shanghai, Shanghai Municipality, China