A Study Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorDuke University

About this trial

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body.

The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online.

The main questions are:

Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose?

Participants will:

Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images.

Participants are followed for about 1 year.

Eligibility criteria

Qualifiers

Female between the age of 15-25 years old.

Weight Concerns Scale score of >=47.

Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).

Disqualifiers

Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.

Change in psychotropic medications in the past month.

Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.

Bipolar disorder not being treated with medication.

Trial design

Treatments tested in this trial

  • FlexED
  • Educational Control

Treatment groups

128 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator