Bulimia NervosaNCT07143214
Wise Eating: A Guided Digital DBT-Based Intervention for Binge Eating
A study testing online dialectical behavior therapy and Waitlist and psychoeducation in people with Bulimia Nervosa and Binge Eating Behaviour, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa, Binge Eating Behaviour, Anorexia Nervosa
- What is being tested?
- online dialectical behavior therapy and Waitlist and psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2025to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must fulfill all following conditions:
- 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.
Who cannot join
- Severe anxiety or depressive symptom. (ii) Investigator-determined contraindications to trial participation based on clinical assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Wise Eating: A Guided Digital DBT-Based Intervention for Binge Eating-A Randomized Controlled Trial
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.
- Being tested
- online dialectical behavior therapy, Waitlist and psychoeducation
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online dialectical behavior therapyBehavioural
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
Waitlist and psychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital DBT group | Experimental | Not described Receives: Behavioral: online dialectical behavior therapy |
| Waitlist control | Placebo comparator | waitlist patient is provided with psychoeducation Receives: Behavioral: Waitlist and psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BES, Binge Eating Scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, treatment period (4 weeks) post-treatment (4 weeks past day 1.), 1 month follow up after treatment, 3 months follow up after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start6 Jun 2025
- Primary completion6 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143214
- Sponsor's protocol ID
- 2024-YJ09
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Likely share upon reasonable request
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wise Eating: A Guided Digital DBT-Based Intervention for Binge Eating-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07143214
- Acronym / sponsor ID
- 2024-YJ09
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital DBT group | Experimental | Behavioral: online dialectical behavior therapy |
| Waitlist control | Placebo comparator | Behavioral: Waitlist and psychoeducationwaitlist patient is provided with psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe anxiety or depressive symptom. (ii) Investigator-determined contraindications to trial participation based on clinical assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online dialectical behavior therapyEnrolled 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 | Behavioural | Digital DBT group |
| Waitlist and psychoeducationThe 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. | Behavioural | Waitlist control |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 41795181Huang 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.
- Individual participant dataSharing planned: Undecided. Likely share upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online dialectical behavior therapy and Waitlist and psychoeducation in people with Bulimia Nervosa and Binge Eating Behaviour, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07143214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.