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CompletedNCT07143214Updated Aug 27, 2025

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

An interventional study of online dialectical behavior therapy and Waitlist and psychoeducation in Bulimia Nervosa, Binge Eating Behaviour and Anorexia Nervosa, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Bulimia Nervosa
  • Binge Eating Behaviour
  • Anorexia Nervosa
  • Eating Disorders
03

In context

Bulimia Nervosa

163 studies on the registry are indexed under Bulimia Nervosa; 39 are open to participants now.

This study's enrollment of 101 is above the median of 60 across 114 interventional studies indexed under Bulimia Nervosa.

Browse Bulimia Nervosa studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Digital DBT group

    Behavioral: online dialectical behavior therapy

  • Placebo comparator
    Waitlist control

    waitlist patient is provided with psychoeducation

    Behavioral: Waitlist and psychoeducation

Interventions

  • Behavioralonline dialectical behavior therapy

    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

  • BehavioralWaitlist and psychoeducation

    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.

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What researchers measure

Primary outcomes

  1. BES, Binge Eating Scale

    Time frame: 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

  1. DERS, Difficulties in Emotion Regulation Scale

    Time frame: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment

  2. PHQ, Patient Health Questionnaire

    Time frame: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment

  3. GAD, Generalized Anxiety Disorder 7-item scale

    Time frame: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment

  4. BIS, Barratt Impulsiveness Scale

    Time frame: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment

  5. EDE-Q, Eating Disorder Examination Questionnaire

    Time frame: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment

07

Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, Shanghai Municipality 200030, China
08

References and documents

Publications

  • Huang W, Zhang Z, Han H, Gao R, Gu L, Peng S, Chen J. Wise Eating: A Guided Dialectical Behavior Therapy-Based APP for Binge Eating-A Randomized Controlled Trial. Int J Eat Disord. 2026 Jun;59(6):1344-1356. doi: 10.1002/eat.70068. Epub 2026 Mar 7. PubMed 41795181 ↗

Individual participant data

Plan to share: Undecided — Likely share upon reasonable request

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07143214
Lead sponsor
Shanghai Mental Health Center
Responsible party
Sponsor
First posted
Aug 27, 2025
Start date
Jun 6, 2025
Primary completion
Jun 6, 2025
Completion
Jun 24, 2025
Last update
Aug 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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