[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07212673":3,"trial-entities:NCT07212673":104,"trial-summary:NCT07212673":108},{"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":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":71,"locations":74,"central_contacts":89,"overall_officials":97,"references":98,"see_also_links":103},"NCT07212673","20251574","Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder","Combining Digital Cognitive-behavior Therapy With Mindfulness Training for Binge Eating Disorder: a Feasibility Randomized Controlled Trial","RECRUITING","2027-10-01","2025-11","2025-11-04","2025-11-02","Yeshiva University","OTHER",true,"The investigators will evaluate the acceptability and feasibility of a 16-session digital mindfulness-based and cognitive behavioral therapy (CBT) intervention for binge eating disorder (BED) + coached self-monitoring vs. a coached self-monitoring intervention. This study is a pilot randomized controlled trial.","Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) the assigned intervention; (4) a mid-study visit; (5) a post-intervention assessment (\\~18-weeks after baseline); and (6) a 2-month follow-up assessment.",[19],"Binge Eating Disorder",[21,22,23],"binge eating","eating disorder","obesity","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","CBT-based Mindful Courage","Self-guided online intervention",[37],"CBT-based Mindful Courage + Coached Self-Monitoring",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Coached Self-Monitoring","Participants will log meals in recovery record",[37,39],[43,47],{"measure":44,"description":45,"timeFrame":46},"Feasibility \u002F Completion (questionnaire developed by our lab)","Number of participants completing intervention","From baseline to 2-month follow-up visit",{"measure":48,"description":49,"timeFrame":50},"Acceptability","Dimensions of usability from the System Usability Scale; single-items measuring dimensions of acceptability, including overall satisfaction, engagement, visual appeal of content, understandability of program content, desire to continue the program, perceived skill acquisition, perceived confidence in implementing skills, and perceived helpfulness. Scores for each item range from 1 to 5, with higher scores indicating better acceptability. Scores will be averaged to obtain acceptability ratings.","After completing intervention, an average of 18-weeks",[],"ALL","18 Years","70 Years",false,{"inclusion":57,"exclusion":62,"raw_text":70},[58,59,60,61],"age 18 years or older","ability to speak English fluently","meeting DSM-5 criteria for current BED (i.e., in the past three months)","willing and able to commit to the entire study protocol",[63,64,65,66,67,68,69],"a BMI below 18.5","requiring immediate treatment for medical complications","having current anorexia or bulimia nervosa or purging behaviors within the past year","being pregnant or breast-feeding","experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active suicidal risk, active psychotic disorder, unmedicated bipolar disorder, severe substance use disorder, cancer)","currently receiving BED or weight loss treatment (treatment for other conditions will be allowed, as long as the treatment is not mindfulness-based)","currently taking medications for weight loss, or beginning medications that affect eating\u002Fweight within the last six months.","Inclusion Criteria:\n\n* age 18 years or older\n* ability to speak English fluently\n* meeting DSM-5 criteria for current BED (i.e., in the past three months)\n* willing and able to commit to the entire study protocol\n\nExclusion Criteria:\n\n* a BMI below 18.5\n* requiring immediate treatment for medical complications\n* having current anorexia or bulimia nervosa or purging behaviors within the past year\n* being pregnant or breast-feeding\n* experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active suicidal risk, active psychotic disorder, unmedicated bipolar disorder, severe substance use disorder, cancer)\n* currently receiving BED or weight loss treatment (treatment for other conditions will be allowed, as long as the treatment is not mindfulness-based)\n* currently taking medications for weight loss, or beginning medications that affect eating\u002Fweight within the last six months.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"The Bronx","New York","10461","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Margaret Sala","CONTACT","972-369-4267","margarita.sala@yu.edu",{"lat":87,"lon":88},40.84985,-73.86641,[90,93],{"name":91,"role":83,"phone":92,"email":85},"Margaret Sala, Ph.D.","19723694267",{"name":94,"role":83,"phone":95,"email":96},"Hedy Kober, Ph.D.","9174708331","hedy@berkeley.edu",[],[99],{"pmid":100,"type":101,"citation":102},"42061840","DERIVED","Sala M, Roos C, Ascarrunz D, Stern CM, Bricker J, Feldman JM, Levinson C, Aslan M, Hay JL, Kober H. Combining Digital Cognitive Behavioral Therapy With Mindfulness Training for Binge Eating Disorder: Protocol for a Feasibility Trial. JMIR Res Protoc. 2026 Apr 17;15:e91761. doi: 10.2196\u002F91761.",[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Binge Eating",[],{"nct_id":4,"found":15,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is a pilot randomized controlled trial, meaning participants will be randomly assigned to one of the two intervention groups. About 40 people are planned to join.","completed","Digital CBT and Mindfulness for Binge Eating Disorder","This study is testing two approaches for Binge Eating Disorder (BED). One approach combines a self-guided online program called CBT-based Mindful Courage with coached self-monitoring (logging meals). The other approach uses only coached self-monitoring. Researchers want to see if these methods are practical to use and if people find them acceptable. You may be able to join if you are 18 to 70 years old, speak English, and meet the criteria for BED. This study is currently recruiting about 40 participants.","Participants will have a 2-month follow-up assessment after the intervention.",81,"You would complete a screening, an initial visit, the assigned intervention, a mid-study visit, a post-intervention assessment around 18 weeks, and a 2-month follow-up.","Not stated in the trial record.",[34,39],"v2"]