Virtual Intervention for Binge Eating Disorder

(VIBE Trial)

Recruiting at 1 trial location

Overseen By Andrew Tyler, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Weight medications

Disqualifiers: Diabetes, Bulimia nervosa, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app designed to help adolescents with binge eating problems manage their eating habits more effectively. The app combines self-regulation strategies with cognitive-behavioral techniques to address unhealthy eating patterns. Participants will use the app for 16 weeks and provide feedback on its effectiveness. Teens who have experienced episodes of uncontrolled eating and have a higher than average BMI may be well-suited for this study. As an unphased study, this trial offers participants a unique opportunity to contribute to innovative research that could lead to new solutions for managing binge eating.

Will I have to stop taking my current medications?

If you are currently taking medications that affect weight or appetite, you cannot participate in this trial.

What prior data suggests that this mobile app intervention is safe for adolescents with dysregulated eating behaviors?

Research has shown that online programs for binge eating are generally safe for teenagers. In one study, participants using an internet-based program to manage binge eating and weight experienced no serious side effects, indicating that virtual tools are usually well-tolerated.

Another study found that symptoms of depression and eating disorders, including binge eating, improved after using a similar program. This improvement, without major negative effects, suggests a positive safety profile.

While this specific app is new, these findings offer hope about its safety. However, it's important to remember that individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the virtual intervention for binge eating disorder because it offers a new way to deliver treatment remotely, making it accessible to more adolescents who might struggle to attend in-person therapy sessions. Unlike traditional treatments such as cognitive behavioral therapy or medication, this virtual approach can be accessed from home, providing convenience and privacy for users. Additionally, the digital format may incorporate interactive and engaging elements that appeal to younger audiences, potentially enhancing their commitment and interest in the treatment process.

What evidence suggests that this virtual intervention is effective for binge eating disorder?

Research has shown that cognitive-behavioral therapy (CBT) effectively treats binge eating disorder (BED). CBT helps individuals change their eating habits by addressing their thoughts and feelings. Studies have found that technology, such as mobile apps, can enhance treatment accessibility and success for young people with eating disorders. This trial will test a virtual intervention that combines CBT with techniques to boost self-control, aiding teenagers in better managing their eating habits. Early reports suggest these digital tools offer a promising way to support recovery from binge eating. ^{1 3 6 7 8}

Who Is on the Research Team?

Andrea K Graham, Ph.D.

Principal Investigator

Northwestern University

Andrea B Goldschmidt, Ph.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adolescents with eating disorders like binge eating, bulimia, and obesity. Participants should be experiencing uncontrolled eating behaviors and have a higher weight status. Specific inclusion or exclusion criteria are not provided but would typically involve age range and health conditions.

Inclusion Criteria

Be willing and able to measure their height and weight prior to study enrollment

My BMI is in the top 25% for my age and gender.

Report recent loss of control eating and/or overeating (≥3 episodes of either type of eating behavior in the past 3 months)

Exclusion Criteria

Not fluent in English at a third-grade reading level or higher

Currently pregnant or lactating

Report more than 2 instances of compensatory behavior (e.g. diuretics, laxatives, vomiting, driven exercise) in the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 virtual visit

Test-run

Eligible adolescents complete a test-run week with a FitBit and Smartscale to ensure trial fit

1 week

Continuous monitoring with devices

Treatment

Participants use the VIBE app and receive coaching for 16 weeks, including skill-building tasks

16 weeks

3 assessment visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

1 assessment visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Intervention for Binge Eating in Adolescents

Trial Overview The study is testing a new mobile app designed to help teenagers manage dysregulated eating through self-regulation strategies combined with cognitive-behavioral treatment. The participants will use the app for 16 weeks while their feedback on its usability and effectiveness is collected.

How Is the Trial Designed?

Group I: Feasibility/Efficacy Testing Participants Experimental Treatment 1 Intervention

All participants will all be assigned to the experimental group in this single-arm open trial.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The parent-based web intervention 'Eltern als Therapeuten (E@T)' showed a significant increase in expected body weight percentage among girls at risk for anorexia nervosa compared to a control group, indicating some efficacy in addressing this risk factor.

Despite the positive outcome on body weight, the study faced challenges with low parental participation and high dropout rates, suggesting that while the intervention may help engaged families, its overall effectiveness is limited by recruitment issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Based, Indicated Prevention for Anorexia Nervosa: Randomized Controlled Trial. Jacobi, C., Hütter, K., Völker, U., et al.[2020]

In a study involving 20 pediatric patients with eating disorders, family therapy delivered virtually showed similar effectiveness in weight restoration compared to in-person therapy at 1, 3, and 6 months.

The findings suggest that virtual family therapy could be a beneficial treatment option for pediatric eating disorder patients, although further research is needed to address study limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric eating disorders: Exploring virtual family therapy during a global pandemic. Pereira, J., Boachie, A., Shipley, C., et al.[2023]

In a 3-year study involving 2,454 students from Missouri public universities, over 56% were identified as being at high risk for eating disorders, highlighting a significant need for targeted interventions.

The use of the Student Bodies-Eating Disorders mobile application led to a significant reduction in restrictive and binge eating behaviors among students with clinical/subclinical eating disorders, demonstrating the efficacy of tailored online interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-wide university implementation of an online platform for eating disorders screening and intervention. Fitzsimmons-Craft, EE., Firebaugh, ML., Graham, AK., et al.[2021]

The guided internet-based treatment program (iBED) for binge-eating disorder (BED) showed that participants who completed the program experienced significant reductions in eating disorder symptoms, indicating its efficacy as a treatment option.

While there were minor differences in depression levels between those who completed the program and those who did not, no significant differences were found in BED symptoms or body mass index, suggesting that iBED is a promising and accessible intervention for individuals with mild to moderate BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based guided self-help for binge-eating disorder and characteristics of completers versus noncompleters. Jensen, ES., Linnet, J., Holmberg, TT., et al.[2021]

A brief, four-session online therapy program for 19 women with binge-eating disorder (BED) showed significant reductions in loss of control over eating and overall eating disorder psychopathology, indicating potential efficacy.

The study demonstrated high feasibility with strong adherence and low dropout rates, suggesting that online therapy could be a practical and effective treatment option for individuals with BED, especially when access to traditional therapy is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the feasibility and potential efficacy of a brief eTherapy for binge-eating disorder: A pilot study. Rom, S., Miskovic-Wheatley, J., Barakat, S., et al.[2023]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

A targeted internet and app-based intervention focusing solely on cognitive-behavioral techniques to modify dietary restraint significantly reduced binge-eating episodes in 403 participants, most of whom reported binge eating weekly.

The intervention not only decreased binge-eating frequency but also improved various secondary outcomes related to eating concerns and psychological distress, with effects sustained at an 8-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting dietary restraint to reduce binge eating: a randomised controlled trial of a blended internet- and smartphone app-based intervention. Linardon, J., Messer, M., Shatte, A., et al.[2023]

A randomized controlled study involving 74 women demonstrated that an Internet-guided self-help program based on cognitive behavioral therapy (CBT) significantly improved binge eating behaviors and related psychological factors over six months, with benefits maintained at a six-month follow-up.

The program was well-accepted by participants, indicating that transferring CBT techniques to an online format can effectively address binge eating disorder (BED) symptoms and improve overall eating disorder psychopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. Carrard, I., Crépin, C., Rouget, P., et al.[2022]

Out of 2685 potential participants interested in binge eating disorder (BED) pharmacotherapy trials, 1230 (45.8%) were found ineligible primarily due to exclusionary psychotropic medications and not meeting BED criteria.

The study highlights the need for future BED pharmacotherapy research to include a wider variety of subjects, such as those with subthreshold BED, comorbid conditions, and older adults, to better understand treatment efficacy across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binge eating disorder pharmacotherapy clinical trails--who is left out? Guerdjikova, AI., McElroy, SL.[2009]

The pilot study involving 18 overweight and obese females with Binge Eating Disorder (BED) showed that a videoconferencing (VC) treatment program is feasible, with 44.4% of participants completing the program, compared to 88.9% in the face-to-face (F2F) group.

Participants in both groups showed improvements in specific eating behaviors, with F2F participants experiencing significant reductions in uncontrolled eating and emotional eating, while VC participants had notable improvements in shape concern and overall eating disorder scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Videoconferencing-Based Binge Eating Disorder Program in Overweight or Obese Females. Yu, Z., Roberts, B., Snyder, J., et al.[2022]

In a study of 179 women participating in a web-based program for eating disorders, the dropout rate was notably high at 50.8%, indicating a significant challenge in retaining participants in online interventions.

Factors such as higher concerns about body shape, increased binge eating and vomiting episodes, and elevated depressive symptoms were found to significantly predict dropout, suggesting that tailored support for individuals with more severe symptoms is essential to improve retention in such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based motivation program for women with eating disorders: eating disorder pathology and depressive mood predict dropout. von Brachel, R., Hötzel, K., Hirschfeld, G., et al.[2022]

Citations

1. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

2. sciencedirect.com sciencedirect.com/science/article/pii/S1077722923000172

Enhanced Family-Based Treatment for an Adolescent With ... Highlights. •. Family-based treatment (FBT) is a potentially effective method for treating adolescents with binge-eating disorder ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818753

Web-Based Cognitive Behavioral Self-Help Intervention for ... While cognitive behavioral therapy (CBT) has demonstrated its effectiveness as an evidence-based BED intervention, treatment rates for this ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9700893/

The use of technology in the treatment of youth with eating ... The online version contains supplementary material available at 10.1186/s40337-022-00697-5. Keywords: Eating disorder, Anorexia nervosa, Bulimia ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06107387

Study Details | NCT06107387 | Binge Eating Self-help for ... Details for study NCT06107387, | ClinicalTrials.gov.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9793802/

Binge eating disorder - PMC - PubMed Central Binge eating disorder (BED) is characterized by regular binge-eating episodes during which individuals ingest comparably large amounts of food and experience ...

7. publications.aap.org publications.aap.org/pediatrics/article/121/3/453/72852/Randomized-Controlled-Trial-of-an-Internet

Randomized, Controlled Trial of an Internet-Facilitated ... OBJECTIVE. This study examined the efficacy of an Internet-facilitated intervention for weight maintenance and binge eating in adolescents.

8. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2822792

Symptoms of Depression, Eating Disorders, and Binge ... In this randomized clinical trial of 141 adolescents, symptoms of depression, eating disorders, and binge eating reduced after 4 weeks of a very low energy ...