Digital Game Intervention for Eating Disorders

Overseen By Rhonda M Merwin, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Psychiatric medications

Disqualifiers: Anorexia, Bulimia, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital game called FlexED, designed to improve body image flexibility in young women and girls with eating disorder symptoms. The researchers aim to assess the game's effectiveness and determine the necessary dosage to make a difference. Participants will use a multimedia app at home for eight sessions over ten weeks. This trial suits young women or girls aged 15-25 who have had ongoing concerns about weight and have used unhealthy weight control methods in the past three years. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new ways of supporting those with eating disorder symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have started or changed psychiatric medications in the past month.

What prior data suggests that this digital intervention is safe for young women and girls with eating disorder symptoms?

Research shows that digital tools like FlexED are usually easy for people to use. Studies on similar apps for eating disorders suggest they can safely and effectively improve body image and eating habits. Many users report enjoying the interactive, game-like features, which make the treatment feel more like a fun activity than a task.

Specific safety data on FlexED is not yet available because it is new and still undergoing testing. However, similar digital therapy tools have not shown any major safety issues, suggesting that FlexED might also be safe due to its similar functionality. Participants should always monitor their feelings and report any concerns during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

FlexED is unique because it offers a digital approach to treating eating disorders, unlike traditional therapies that often involve in-person sessions with therapists or nutritional counseling. This online, multimedia application delivers eight interactive sessions that users can access anytime, making it highly convenient and accessible. Researchers are excited about FlexED because it has the potential to engage patients in a new, technology-driven format that could enhance motivation and adherence to treatment, especially among younger populations who are familiar with digital platforms.

What evidence suggests that this digital intervention is effective for eating disorders?

Research has shown that digital tools can aid in treating eating disorders by improving body image and acceptance. Early findings suggest that multimedia apps offer a unique and engaging treatment approach. In this trial, participants will use the digital intervention FlexED, which includes eight 20-30 minute sessions of an online, multimedia application. Studies have found that online cognitive-behavioral therapies effectively assist individuals with conditions like bulimia nervosa. These programs provide support accessible from home, making them a convenient choice for many. While more research is needed to fully understand their impact, current evidence supports the potential benefits of these digital tools for those dealing with eating disorders. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young women and girls aged 15-25 who are experiencing symptoms of eating disorders. They should be concerned about their weight (scoring over 47 on a specific scale) and have started unhealthy weight control behaviors within the last three years.

Inclusion Criteria

Weight Concerns Scale score of >47

Maladaptive weight control behaviors with onset <3 years

I am a female aged between 15 and 25.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are randomized to different baseline durations to measure Body Image Flexibility

2-6 weeks

Home-based assessments

Treatment

Participants complete eight 20-30 minute sessions of a multimedia application over 10 weeks

10 weeks

Home-based sessions

Follow-up

Participants are monitored for changes in body image flexibility and other outcomes

6 weeks

Home-based assessments

What Are the Treatments Tested in This Trial?

Interventions

• FlexED

Trial Overview The FlexED program, a digital game-like intervention designed to help with eating disorders, is being tested. Participants will use an app for eight sessions over ten weeks to see if it improves how they view their body image.

How Is the Trial Designed?

Group I: Digital Intervention Experimental Treatment 1 Intervention

Eight 20-30 minute sessions of an online, multimedia application

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Cyprus

Collaborator

Trials

29

Recruited

11,000+

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10243293/

An overview of the treatment of eating disorders in adults and ... At the moment, the recommended psychotropic medication for eating disorders is represented by fluoxetine for bulimia nervosa and lisdexamfetamine for binge ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724019414

Residential versus day program treatment for eating ... Post-treatment outcomes were not predicted by age or baseline BMI, anxiety, or depression. As symptom severity did not differ at baseline, ...

4. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00801-3

Eating disorder outcomes: findings from a rapid review of over ... Eating disorders (ED), especially Anorexia Nervosa (AN), are internationally reported to have amongst the highest mortality and suicide ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820707

Web-Based Cognitive Behavioral Treatment for Bulimia ... This randomized clinical trial examines the use of a web-based self-help intervention for use by individuals with bulimia nervosa.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9468918/

The Role of Serious Video Games in the Treatment ... However, besides the aforementioned eating disorders, disordered eating may also refer to pathological eating behaviors, including restricting, ...

7. games.jmir.org games.jmir.org/2021/2/e24998/

Virtual Reality App for Treating Eating Behavior in Eating ... Background: Anorexia nervosa is one of the more severe eating disorders, which is characterized by reduced food intake, leading to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05609409

FlexED: A Digital, Gamified Early Intervention for Eating ... Details for study NCT05609409, | ClinicalTrials.gov.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12336746/

Maze‐Out: A Serious Game to Enhance Treatment for Eating ... 2024). Keywords: anorexia nervosa, bulimia nervosa, coproduction, eating disorders, E‐health, play, randomized controlled trial, serious games ...