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

Duke University

Status: Not yet enrolling

Conditions: Eating Disorders; Body Image

Treatments: Behavioral: FlexED; Behavioral: Educational Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07632248

Pro00111571_1

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• Currently in treatment for an eating disorder.
• Non-English speaking.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

"FlexED"

Experimental group

Description:

Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.

Treatment:

Behavioral: FlexED

Educational Control

Active Comparator group

Description:

Seven 20-minute online education sessions about eating disorders.

Treatment:

Behavioral: Educational Control