FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Study Overview
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Brief Summary
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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.

Official Title
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FlexED: A Digital, Gamified Early Intervention for Eating Disorders

Conditions
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Eating Disorders, Body Image

Intervention / Treatment
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* Behavioral: FlexED


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Intervention<br>Eight 20-30 minute sessions of an online, multimedia application | Behavioral: FlexED<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating Disorders, Body Image Flexibility, Acceptance and Commitment Therapy, Psychological Flexibility, Online, Early Intervention