Virtual Intervention for Binge Eating Disorder

(VIBE Trial)

Recruiting at 1 trial location

Overseen By Abigail Wharton, M.S.

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

Trial Summary

What is the purpose of this trial?

The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated 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 data supports the effectiveness of the treatment Virtual Intervention for Binge Eating in Adolescents?

Research shows that online therapy (eTherapy) can help reduce binge-eating symptoms, and cognitive behavioral therapy (CBT) delivered via the Internet has been effective for adults with binge eating disorder. These findings suggest that virtual interventions could be beneficial for adolescents with binge eating disorder as well. ^{1 2 3 4 5}

Is the virtual intervention for binge eating disorder safe for humans?

The virtual intervention for binge eating disorder appears to be safe, as studies have shown it is feasible and acceptable for participants, with no significant adverse effects reported in the research. ^{1 6 7 8 9}

How is the Virtual Intervention for Binge Eating in Adolescents treatment different from other treatments for binge eating disorder?

This treatment is unique because it uses a virtual format, making it more accessible and potentially less costly than traditional face-to-face therapy. It focuses on cognitive-behavioral techniques to address dietary restraint, a key factor in binge eating, and is delivered through online platforms, which can be more convenient for adolescents. ^{1 3 9 10 11}

Research Team

Andrea B Goldschmidt, Ph.D.

Principal Investigator

University of Pittsburgh

Andrea K Graham, Ph.D.

Principal Investigator

Northwestern University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Paediatric eating disorders: Exploring virtual family therapy during a global pandemic. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Internet-based motivation program for women with eating disorders: eating disorder pathology and depressive mood predict dropout. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluating the feasibility and potential efficacy of a brief eTherapy for binge-eating disorder: A pilot study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Based, Indicated Prevention for Anorexia Nervosa: Randomized Controlled Trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

State-wide university implementation of an online platform for eating disorders screening and intervention. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Binge eating disorder pharmacotherapy clinical trails--who is left out? [2009]

9. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Videoconferencing-Based Binge Eating Disorder Program in Overweight or Obese Females. [2022]

10. England 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based guided self-help for binge-eating disorder and characteristics of completers versus noncompleters. [2021]