128 Participants NeededMy employer runs this trial

FlexED for Eating Disorders

RM
HB
DR
Overseen ByDottie R Mayo
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
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 aims to determine if a new digital program, FlexED, can assist young women and girls struggling with body image and eating disorder symptoms. Based on Acceptance and Commitment Therapy (ACT), the program helps users manage thoughts and feelings about their bodies. Participants will be divided into two groups: one will use the digital program, and the other will engage with online educational modules about eating disorders. The trial seeks females aged 15 to 25 who have significant weight concerns and engage in eating disorder behaviors such as extreme dieting or binge eating. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new, effective interventions for eating disorders.

What prior data suggests that this digital intervention is safe for young women and girls at risk for eating disorders?

Research has shown that digital tools like FlexED, which incorporate methods from Acceptance and Commitment Therapy (ACT), are generally safe. As an app, FlexED does not involve physical or chemical treatments, reducing the likelihood of physical side effects.

In similar studies with ACT-based digital programs, participants have found these tools easy to use, with few reports of negative effects. The focus on improving how people manage thoughts, feelings, and body image suggests a low-risk approach aimed at helping without causing harm.

Although specific safety data for FlexED is not yet available, its digital and non-invasive nature suggests it is likely safe to use. This trial does not involve physical treatments, so the usual risks associated with new drugs or medical devices are not a concern.12345

Why are researchers excited about this trial?

Unlike traditional treatments for eating disorders that often involve in-person therapy and focus on managing symptoms, FlexED is an innovative online application designed to enhance psychological flexibility when dealing with body-image related thoughts and feelings. This digital approach offers a unique delivery method, allowing users to engage in seven concise, 20-minute multimedia sessions from the comfort of their own homes. Researchers are excited about FlexED because it represents a shift towards more accessible, self-guided interventions that could make it easier for individuals to seek help and maintain engagement with their treatment.

What evidence suggests that this digital intervention is effective for reducing eating disorder symptoms?

Research has shown that Acceptance and Commitment Therapy (ACT), the foundation of the FlexED digital program, can help people become more flexible in their thoughts and feelings about their bodies, aiding in better adaptation to body image. One study found that individuals with eating disorders felt more confident in their bodies and less afraid of gaining weight when using these methods. Another study demonstrated that such programs can improve self-perception and body image while reducing negative thoughts and symptoms related to eating disorders. This trial will compare the FlexED program, provided to participants in one arm, to an educational control group. These findings suggest that FlexED could effectively reduce eating disorder symptoms by altering participants' thoughts and feelings about their bodies.24678

Are You a Good Fit for This Trial?

This trial is for females aged 15-25 who are worried about their weight and have shown at least one eating disorder behavior, such as extreme dieting, excessive exercise, binge eating, or purging.

Inclusion Criteria

Weight Concerns Scale score of >=47
I am a female between 15 and 25 years old.
Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors)

Exclusion Criteria

Currently in treatment for an eating disorder
I currently have or previously had an eating or feeding disorder.
I have changed my psychiatric medications in the past month.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete seven brief digital sessions over about 8 weeks, including interviews, surveys, and lab assessments.

8 weeks
7 digital sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points.

1 year
Assessments at 12, 24, 36, and 48 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • FlexED

Trial Overview

The study compares a new digital program based on Acceptance and Commitment Therapy (ACT) to standard online educational modules. Participants are randomly assigned to either group and complete seven short sessions over about eight weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: "FlexED"Experimental Treatment1 Intervention
Group II: Educational ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Social Media Effects Regarding Eating Disorders and Body ...

Abstract. The following study investigates how eating problems and young people's body image are affected by social media.

Body image flexibility and embodiment in eating disorders: a ...

ED group displayed improvements in key dimensions such as body trust, body image flexibility, and a reduction in weight phobia, self-monitoring ...

Body Image | Risks, Eating Disorders & Resources | NEDA

Learn about negative body image risks, how they are linked to eating disorders, and find resources to support a healthy body image at NEDA.

Body Image

Body dissatisfaction is an internal emotional and cognitive process but is influenced by external factors such as pressures to meet a certain appearance ideal.

Body image and diets

A negative body image can lead to dieting and disordered eating behaviours, and increases the risk for the development of an eating disorder. A positive body ...

Eating Disorder Hotlines for 24/7 Crisis Help

There are several eating disorder hotlines you can call 24/7 if you or someone you know needs help with an eating disorder.

Media and Eating Disorders

Learn about the effects of media on eating disorders and media self-care. Visit the Resource Center at National Eating Disorders Association.

Mounting Research Documents the Harmful Effects of ...

Research shows that images of beauty as depicted in movies, television and magazines can lead to mental illness, issues with disordered eating ...