Wise Eating: A Guided Digital DBT-Based Intervention for Binge Eating

NCT07143214 | Completed

• 1 other identifier: 2024-YJ09
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa; Binge Eating Behaviour; Anorexia Nervosa; Eating Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Digital DBT group

EXPERIMENTAL

Behavioral: online dialectical behavior therapy

Waitlist control

PLACEBO COMPARATOR

waitlist patient is provided with psychoeducation

Behavioral: Waitlist and psychoeducation

Interventions

online dialectical behavior therapy BEHAVIORAL

Enrolled participants will be provided with credentials to access the mobile application for a 28-day therapist-supported DBT self-help intervention. Participants are required to engage with the application at least once daily throughout the 4-week intervention period, with each session requiring approximately 30 minutes of engagement. The application delivers automated daily reminders at user-configurable timepoints. Additionally, participants receive asynchronous text-based guidance via WeChat during the treatment phase, wherein therapists provide support, feedback, and clinical direction during predetermined response windows. Each participant's cumulative weekly guidance duration is capped at 15 minutes. The application's therapeutic framework integrates core components from The Dialectical Behavior Therapy Skills for Emotional Eating and standardized DBT treatment manuals, structured across four evidence-based modules: (1) Mindfulness, (2) Distress Tolerance, (3) Interpersonal Eff

Digital DBT group

Waitlist and psychoeducation BEHAVIORAL

The active control group serves as a rigorous placebo comparator condition. Participants allocated to this arm will receive daily psychoeducational communications regarding binge-eating pathology, encompassing epidemiological data, biopsychosocial determinants, clinical manifestations, and therapeutic approaches. Crucially, all disseminated content remains devoid of Dialectical Behavior Therapy (DBT)-related components or skill-building elements.

Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must fulfill all following conditions:

You may not qualify if:

• (i) Severe anxiety or depressive symptom. (ii) Investigator-determined contraindications to trial participation based on clinical assessment.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Bulimia Nervosa; Binge-Eating Disorder; Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 27, 2025
• Study Start: June 6, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 24, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CN (1)