FlexED: A Digital, Gamified Early Intervention for Eating Disorders

NCT05609409 | Completed Results

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

Brief Summary

The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old. Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments. Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.

Conditions

Eating Disorders; Body Image

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Change in 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, 6-8 weeks and 12 weeks

• 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. Indexed by HF Power ms\^2 (Induction-Rest).

  Baseline, 6-8 weeks, and 12 weeks

• Change From Baseline 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 decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli).

  Baseline, 6-8 weeks, and 12 weeks

• CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)

  10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility.

  Baseline, 6-8 weeks, 12 weeks

• Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli

  Number of fixations on body and food related images presented during HF-HRV task.

  Baseline, 6-8 weeks, 12 weeks

Study Arms (4)

2-Week Baseline Duration

EXPERIMENTAL

2 weeks of assessment, then 8 weeks of intervention

Behavioral: FlexED

4-Week Baseline Duration

EXPERIMENTAL

4 weeks of assessment, then 8 weeks of intervention

Behavioral: FlexED

6-Week Baseline Duration

EXPERIMENTAL

6 weeks of assessment, then 8 weeks of intervention

Behavioral: FlexED

Condensed schedule

EXPERIMENTAL

2 weeks of assessment, then 4 weeks of intervention (sessions twice a week)

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.

2-Week Baseline Duration; 4-Week Baseline Duration; 6-Week Baseline Duration; Condensed schedule

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
• Eating disorder behaviors with onset at current level \<3 years

You may not qualify if:

• Currently meet diagnostic criteria for anorexia or bulimia nervosa
• 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 includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).

Sponsors & Collaborators

• University of Cyprus: collaborator
• Duke University: lead

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

Results Point of Contact

• Title: Rhonda M. Merwin, PhD
• Organization: Duke University

rhonda.merwin@duke.edu

(919) 681-7231

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• 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 6, 2026
• Results First Posted: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)