[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732829":3,"trial-entities:NCT07732829":109,"trial-summary:NCT07732829":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":66,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":14,"eligibility_criteria":70,"std_ages":80,"locations":83,"central_contacts":101,"overall_officials":106,"references":107,"see_also_links":108},"NCT07732829","Pro00111571_3","FlexED: Full Threshold ED Substudy","FlexED: A Digital Gamified Early Intervention for Eating Disorders","NOT_YET_RECRUITING","2028-07","2026-07","2026-07-29","Duke University","OTHER",false,"The purpose of this study is to test whether a new digital intervention decreases eating disorder symptoms in young women with eating disorders by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete up to 7 digital intervention sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards.\n\nResearchers will examine the impact of the intervention on participants' ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye movements, and reaction time to body-image related words and images, and examine changes in eating disorder symptoms before and after intervention.","This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility eating disorder symptoms. Up to 6 young women and girls between the ages of 15-25 with full threshold eating disorder symptoms or diagnoses will complete an initial baseline assessment, and then be assigned to different assessment (baseline) periods ranging from 2-6 weeks. They will then complete 7 fully digital sessions over 8 weeks at home using their mobile phone. Psychological flexibility will be measured repeatedly via self-report and multi-level, multi-dimensional lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects. Eating disorder symptoms will also be assessed pre and post intervention.",[18,19],"Eating Disorders","Body Image",[21,18,22,23,24],"Body Image Flexibility","Acceptance and Commitment Therapy","Psychological Flexibility","Early Intervention","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},6,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","FlexED","Intervention consists of seven \\~ 20-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.",[38,39,40],"2-Week Baseline Duration","4-Week Baseline Duration","6-Week Baseline Duration",[42,46,49,52,55,58,62],{"measure":43,"description":44,"timeFrame":45},"Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5","Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility\u002Fadaptability.","Every 2 weeks to 8 weeks and 12 weeks",{"measure":47,"description":48,"timeFrame":45},"Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)","A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility\u002Fadaptability.",{"measure":50,"description":51,"timeFrame":45},"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.",{"measure":53,"description":54,"timeFrame":45},"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.",{"measure":56,"description":57,"timeFrame":45},"Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images","Heart rate variability measured with BIOPAC during the viewing of body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Increases indicate greater flexibility\u002Fadaptability.",{"measure":59,"description":60,"timeFrame":61},"Change from Baseline in Weight Concern Scale Score","5-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Elevated scores have been associated with the development of eating disorders.","Baseline, 8 weeks and 12 weeks",{"measure":63,"description":64,"timeFrame":65},"Change from Baseline in Eating Disorder Examination (EDE)","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.","Baseline and 12 weeks",[],"ALL","15 Years","25 Years",{"inclusion":71,"exclusion":75,"raw_text":79},[72,73,74],"Female age 15-25 years","Weight Concerns Scale score of \\>=47","Meets diagnostic criteria for an eating disorder based on the DSM-5",[76,77,78],"Psychosis, substance use disorder, or current suicidal ideation or self-harm","Start or change in psychiatric medications within the past month","Non-English speaking","Inclusion Criteria:\n\n* Female age 15-25 years\n* Weight Concerns Scale score of \\>=47\n* Meets diagnostic criteria for an eating disorder based on the DSM-5\n\nExclusion Criteria:\n\n* Psychosis, substance use disorder, or current suicidal ideation or self-harm\n* Start or change in psychiatric medications within the past month\n* Non-English speaking",[81,82],"CHILD","ADULT",[84],{"facility":12,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"Durham","North Carolina","27705","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"Dottie Mayo","CONTACT","919-668-1935","dottie.mayo@duke.edu",{"name":96,"role":97},"Rhonda M Merwin, PhD","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},35.99403,-78.89862,[102],{"name":103,"role":92,"phone":104,"email":105},"Rhonda Merwin, PhD","919-681-7231","rhonda.merwin@duke.edu",[],[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Eating Disorder",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study with an unclear status, planning to enroll up to 6 young women. It uses a multiple baseline experiment design.","completed","FlexED: Digital Intervention for Eating Disorders","This study, called FlexED, is testing a new digital program designed to help young women with eating disorders. The program, also called FlexED, uses Acceptance and Commitment Therapy (ACT) to help you respond more flexibly to difficult thoughts and feelings about your body. You'll use your mobile phone to complete seven sessions, each about 20 minutes long, which include a story, interactive exercises, and games. Researchers want to see if this program can reduce eating disorder symptoms and improve how you cope with body image distress. To join, you must be a female between 15 and 25 years old, have certain weight concerns, and meet the diagnostic criteria for an eating disorder. You cannot participate if you have psychosis, substance use disorder, current suicidal thoughts, or have recently started or changed psychiatric medications. Success in this study means seeing improvements in your body image flexibility and eating disorder symptoms.","Your progress will be measured every 2 weeks up to 8 weeks, and then again at 12 weeks after starting the intervention.",149,"You will complete an initial assessment, followed by 2-6 weeks of baseline assessments. Then, you will complete 7 fully digital sessions over 8 weeks using your mobile phone at home.","Not stated in the trial record.",[35],"v2"]