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

BEHAVIORAL

FlexED

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.

BEHAVIORAL

Educational Control

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.

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

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

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.

Change from Baseline in the Body-Image Stroop Bias Score

Time frame: Baseline, 8 weeks, 24 weeks

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.

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

Time frame: Baseline, 8 weeks, 24 weeks

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.

Acceptability of the intervention

Time frame: 8 weeks

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

Change from Baseline in Eating Disorder Examination (EDE)

Time frame: Baseline, 12 weeks, 24 weeks

Clinician-administered interview assessing eating disorder symptom severity, producing a Global score (main outcome) and 4 Subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. Higher scores indicate greater symptomatology.

Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q)

Time frame: Baseline, 12, 24, 36, 48 weeks

Questionnaire format of the clinician-administered interview assessing eating disorder symptom severity, producing a Global score (main outcome) and 4 Subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. Higher scores indicate greater symptomatology.

Change from Baseline in the Clinical Impairment Assessment (CIA)

Time frame: Baseline, 12, 24, 36, 48 weeks

Measures the extent to which eating disorder symptoms impair functioning. Higher scores indicate greater impairment.

Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)

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

A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.

Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility

Time frame: Baseline, 8 Weeks

4 days of ecological momentary assessment of 1) distress/body-image distress 2) problematic behaviors to change body weight/shape, 3) general attempts to suppress/get rid of unwanted thoughts and feelings, 4) avoiding doing things because of concern about body, and 5) the ability to maintain adaptive distance and 6) orient to values. Scaled items are on a Likert Scale 1=Not at All to 6=Very Much. For items 1-4, higher scores are more problematic; For items 5-6, higher scores are more flexible adaptive.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.