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A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

ConditionsEating DisordersBody Image
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorDuke University

About this trial

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body.

The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online.

The main questions are:

Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose?

Participants will:

Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images.

Participants are followed for about 1 year.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female between the age of 15-25 years old.

Weight Concerns Scale score of >=47.

Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).

Disqualifiers

Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.

Change in psychotropic medications in the past month.

Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.

Bipolar disorder not being treated with medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FlexED

    Behavioral

    Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.

  • Educational Control

    Behavioral

    Intervention consists of seven digital online sessions of education about eating disorders and body image. Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: "FlexED"Experimental treatment 1 intervention
Group B: Educational ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)

Self-report measure of body-image psychological flexibility. The measure consists of 13 (full measure) or 5 (short measure) items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.

Time frame
Baseline, 4, 8, 12, 24, 36, 48 weeks
2

Change from Baseline in the Body-Image Stroop Bias Score

Change in reaction time to body-related versus neutral words in an emotional stroop paradigm. In this paradigm, participants identify the color of the written word as quickly as possible. Differences in reaction time between emotionally relevant words and neutral words is calculated as a bias score. Lower bias scores indicate improvement.

Time frame
Baseline, 8 weeks, 24 weeks
3

Change from Baseline in Eye Gaze Fixations - Body-Image Related Images

Change in the number of fixations on body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Fewer fixations indicate improvement.

Time frame
Baseline, 8 weeks, 24 weeks
4

Acceptability of the intervention

Enrollment targets met, \>70% of participants that start the intervention will complete \>80%, \>70% of participants and sessions will have user inputs indicating engagement.

Time frame
8 weeks

Secondary outcomes

1

Change from Baseline in Heart Rate when Viewing Emotional Film Clips

Heart rate and heart rate variability measured with BIOPAC during the viewing of film clips (neutral, emotional-general, emotional-body-image related). Increases indicate greater flexibility/adaptability.

Time frame
Baseline, 8 weeks, 24 weeks
2

Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)

68-item computerized version of the WCST using default settings; perseverative errors. Decreases in errors indicates greater cognitive flexibility/adaptability.

Time frame
Baseline, 24 weeks
3

Change from Baseline in Response Inhibition as assessed by Go/No-Go Task

The Go/No-Go task measures ability to inhibit a response when signaled (among other outcomes), measured by commission errors (frequency of responding when signaled to not respond); Other indices include sensitivity (ability to discriminate go/no go trials) and reaction time to go stimuli. Commission errors are of primary interest; decreases indicate reductions in impulsivity / improvement.

Time frame
Baseline, 8 weeks, 24 weeks

Other outcomes

1

Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3

EDI-3 Body Dissatisfaction (BD) Subscale, 10 items assessing contentment with specific body parts on a 6-point Likert scale (alternative mechanism of change). Higher scores indicate greater symptomatology.

Time frame
Baseline, 8 Weeks
2

Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale

4-item scale assessing the extent to which social media use interfered or caused problems in life, with an additional item of hours of use (exploratory). Decreases indicate improvement.

Time frame
Baseline, 12 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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