6 Participants NeededMy employer runs this trial

FlexED for Eating Disorders

RM
Overseen ByRhonda Merwin, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool called FlexED to determine its effectiveness in helping young women with eating disorders manage thoughts and feelings about their bodies. Based on Acceptance and Commitment Therapy (ACT), the tool includes interactive mobile sessions with games and digital rewards. Researchers will examine changes in symptoms and reactions to body image stress. Young women concerned about their weight and diagnosed with an eating disorder may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative digital therapy methods for personal growth and support.

What prior data suggests that this digital intervention is safe for young women with eating disorders?

Research has shown that digital programs like FlexED are generally user-friendly. FlexED is an online tool featuring interactive exercises and games designed to help young women with eating disorders manage their symptoms. Users of similar digital tools have reported very few negative effects, suggesting that the treatment is likely safe, as it does not involve medication that might cause physical side effects.

This program is based on Acceptance and Commitment Therapy (ACT), a common therapeutic approach. ACT is considered safe because it focuses on thoughts and feelings rather than physical treatments. Participants in ACT-based digital programs often report positive experiences.

Although specific data from the sources here is unavailable, the digital and non-invasive nature of this program suggests a lower risk of negative effects compared to treatments involving medication.12345

Why are researchers excited about this trial?

FlexED is unique because it offers a flexible and personalized approach to treating eating disorders, unlike conventional methods that often follow a one-size-fits-all protocol. Traditional treatments typically include cognitive-behavioral therapy and nutritional counseling, which can take a while to show results. Researchers are excited about FlexED because it allows for varying baseline durations tailored to individual needs, potentially enhancing engagement and effectiveness. By customizing the assessment period before the intervention, FlexED aims to optimize outcomes and may provide quicker and more sustainable improvements compared to standard care.

What evidence suggests that the FlexED digital intervention could be effective for eating disorders?

Research has shown that digital tools can help reduce eating disorder symptoms by assisting individuals in managing their thoughts and feelings about their bodies. Studies on similar digital tools have demonstrated improvements in eating disorder symptoms, depression, and the avoidance of difficult emotions. In one study, participants who completed digital treatments reported a significant drop in their eating disorder symptoms. Another study tested a game-like digital tool similar to FlexED and found a decrease in symptoms among young women and girls. These findings suggest that FlexED's approach, which uses interactive exercises and games, may effectively help users handle body-image distress more flexibly. Participants in this trial will experience different baseline durations before the intervention, allowing for a comprehensive assessment of FlexED's impact.26789

Are You a Good Fit for This Trial?

This trial is for young women who have an eating disorder, such as anorexia nervosa, body dysmorphic disorder, or other specified eating disorders. Participants should be willing to use a mobile phone app and complete several digital sessions.

Inclusion Criteria

I have been diagnosed with an eating disorder.
I am a female between 15 and 25 years old.
Weight Concerns Scale score of >=47

Exclusion Criteria

Non-English speaking
I have started or changed psychiatric medications in the past month.
Psychosis, substance use disorder, or current suicidal ideation or self-harm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete an initial baseline assessment and are assigned to different baseline periods ranging from 2-6 weeks

2-6 weeks

Digital Intervention

Participants complete 7 digital intervention sessions using their mobile phone over 8 weeks

8 weeks

Follow-up

Participants are monitored for changes in eating disorder symptoms and psychological flexibility

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • FlexED

Trial Overview

The study tests a new digital program called FlexED, based on Acceptance and Commitment Therapy (ACT). Participants do up to 7 interactive sessions on their phones with stories, exercises, games, and rewards. The goal is to help manage thoughts and feelings about body image.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: 6-Week Baseline DurationExperimental Treatment1 Intervention
Group II: 4-Week Baseline DurationExperimental Treatment1 Intervention
Group III: 2-Week Baseline DurationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Research & Outcomes

Patients treated with the new approach showed improvement in eating disorders, depression, and emotional avoidance not only at discharge but at the six-month ...

child and adolescent eating disorder treatments in the real ...

At discharge, 77% of the AN/Atypical AN group had a good or intermediate outcome and 59% of the BN/Atypical BN group reported no or fewer than ...

3.

nationaleatingdisorders.org

nationaleatingdisorders.org/statistics/

Eating Disorder Statistics

The most common eating disorder is Other Specified Feeding or Eating Disorder (OSFED) with a one-year prevalence of 1.18% for females and 0.27% for males.

Eating disorder outcomes: findings from a rapid review of over ...

Of the over 1320 studies included in the Rapid Review, the proportion of articles focused on outcomes in ED was relatively small, under 9%. Most ...

Residential versus day program treatment for eating ...

A systematic review of 19 studies supported positive outcomes from residential treatment for eating disorder symptoms, anxiety, depression, ...

Eating Disorder Hotlines for 24/7 Crisis Help

Phone: 1-800-950-NAMI (1-800-950-6264) Phone: 1-800-799-SAFE (1-800-799-7233) Phone: 1-888-843-4564

Safety Behaviors Exacerbate Eating Disorder Fears - PMC - NIH

The present study tested to what extent eating disorder safety behaviors increase threat perception in individuals with and without an eating ...

A Study Testing a Digital, Gamified Early Intervention for ...

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at ...

Rigid vs. flexible dieting: association with eating disorder ...

The correlates of rigid and flexible dieting were examined in a sample of 188 nonobese women recruited from the community and from a university.