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FlexED: A Digital, Gamified Early Intervention for Eating Disorders

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Duke University

Status

Active, not recruiting

Conditions

Eating Disorders
Body Image

Treatments

Behavioral: FlexED

Study type

Interventional

Funder types

Other

Identifiers

NCT05609409
Pro00111571

Details and patient eligibility

About

The goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. Twenty-four young women and girls (between the ages of 15-25) with eating disorder (ED) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). Participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. Body Image Flexibility (BIF) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. The investigators will estimate the effect of the intervention on BIF and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.

Enrollment

24 estimated patients

Sex

All

Ages

15 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female identified 15-25 years old
  • Weight Concerns Scale score of >47
  • Maladaptive weight control behaviors with onset <3 years

Exclusion criteria

  • Currently meets full diagnostic criteria anorexia or bulimia nervosa or has in the past.
  • Psychosis, substance use disorder or current suicidal ideation or self-harm.
  • Start or change in psychiatric medications within the past month.
  • NonEnglish Speaking.
  • Presents with other specified feeding or eating disorder (OSFED) that does not have weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Digital Intervention
Experimental group
Description:
Eight 20-30 minute sessions of an online, multimedia application
Treatment:
Behavioral: FlexED

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Dorothy Mayo; Rhonda M Merwin, PhD

Data sourced from clinicaltrials.gov

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