FlexED: A Digital, Gamified Early Intervention for Eating Disorders

NCT05609409 | Completed

• 1 other identifier: Pro00111571
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Body Image

Keywords

Eating Disorders; Body Image Flexibility; Acceptance and Commitment Therapy; Psychological Flexibility; Online; Early Intervention

Outcome Measures

Primary Outcomes (3)

• Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)

  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.

  Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks

• Change in High Frequency Heart Rate Variability (HF-HRV)

  Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress.

  Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks

• Change in biased processing of body image stimuli relative to neutral stimuli

  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.

  Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks

Study Arms (1)

Digital Intervention

EXPERIMENTAL

Eight 20-30 minute sessions of an online, multimedia application

Behavioral: FlexED

Interventions

FlexED BEHAVIORAL

Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.

Digital Intervention

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Female-identified
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: lead
• University of Cyprus: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: June 1, 2024
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)