FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Eating Disorders Clinical Trial

Official title:

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609409
• Other study ID #: Pro00111571
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Rhonda M Merwin, PhD
• Phone: 919-681-7231
• Email: rhonda.merwin[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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).

Related Conditions & MeSH terms

• Body Image
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• FlexED
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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of Cyprus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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