FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Not Applicable

Active, not recruiting

• Conditions: Body Image; Eating Disorders
• Interventions: Behavioral: FlexED

• Registration Number: NCT05609409
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-08
• Study Start: 2024-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital Intervention	FlexED	Eight 20-30 minute sessions of an online, multimedia application

Primary Outcome Measures

Name	Time	Method
Change in High Frequency Heart Rate Variability (HF-HRV)	Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks	Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress.
Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)	Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks	5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
Change in biased processing of body image stimuli relative to neutral stimuli	Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks	Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by changes in reaction time and fewer errors.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States