Duke University
Durham, North Carolina, 27705, United States
Location contact
Dottie Mayo
CONTACT
Hallie B Wolfe
CONTACT
Rhonda M Merwin, Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07632248
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.
Trial opening soon.
Get Notified15 year–25 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Dottie Mayo
CONTACT
Hallie B Wolfe
CONTACT
Rhonda M Merwin, Ph.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline, 12, 24, 36, 48 weeks
Measures the extent to which eating disorder symptoms impair functioning. Higher scores indicate greater impairment.
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.
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.
Time frame: Baseline, 8 weeks, 24 weeks
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, 24 weeks
68-item computerized version of the WCST using default settings; perseverative errors. Decreases in errors indicates greater cognitive flexibility/adaptability.
Time frame: Baseline, 8 weeks, 24 weeks
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
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, 12 Weeks
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.
Contact information is provided by the study sponsor or research team.
Hallie B Wolfe
CONTACT
Rhonda M Merwin, Ph.D.
CONTACT
Duke University
Other
A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07678554
Body Dysmorphic Disorders, Body Image
Stanford, California, United States
View Trial DetailsNCT05609409
Body Image, Eating Disorders
Durham, North Carolina, United States
View Trial DetailsNCT07512479
Anorexia, Anorexia Nervosa
Treviso, Italy
View Trial DetailsNCT05993728
Body Image, Eating Disorders
Oslo, Norway
View Trial Details