[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04810624":3,"trial-entities:NCT04810624":127,"trial-summary:NCT04810624":130},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":60,"secondary_outcomes":65,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":99,"locations":101,"central_contacts":117,"overall_officials":120,"references":121,"see_also_links":126},"NCT04810624","8110","Relapse Prevention and Changing Habits in Anorexia Nervosa","Optimizing Relapse Prevention and Changing Habits in Anorexia Nervosa","RECRUITING","2027-06-01","2026-03","2026-06-01","2021-06-21","New York State Psychiatric Institute","OTHER",null,"This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.\n\nIn the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status.","While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment.",[19],"Anorexia Nervosa",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Relapse Prevention and Changing Habits (REACH+)","Psychotherapy",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"Do, Accept, Motivation Through Values, Sessions, Long-Term Food Logs,","Do, Accept, Motivation through Narratives, Check-Ins, Long-Term Food Logs","Do, Accept, Motivation through Narratives, Sessions, No Food Logs","Do, Accept, Motivation through Narratives, Sessions, Short-Term Food Logs","Do, Accept, Motivation through Values, Check-Ins, No Food Logs","Do, Accept, Motivation through Values, Check-Ins, Short-Term Food Logs","Do, Accept, Motivation through Values, Sessions, Short-Term Food Logs","Do, Change, Motivation Through Narratives, Sessions, Long-term Food Logs","Do, Change, Motivation Through Values, Sessions, No Food Logs","Do, Change, Motivation Through Values, Sessions, Short-Term Food Logs","Do, Change, Motivation through Narratives, Check-Ins, No Food Logs","Do, Change, Motivation through Narratives, Check-Ins, Short-Term Food Logs","Do, Change, Motivation through Values, Check-Ins, Long-Term Food Logs","Talk, Accept, Motivation through Narratives, Check-Ins, No Food Logs","Talk, Accept, Motivation through Narratives, Check-Ins, Short-Term Food Logs","Talk, Accept, Motivation through Narratives, Sessions, Long-Term Food Logs","Talk, Accept, Motivation through Values, Check-Ins, Long-Term Food Logs","Talk, Accept, Motivation through Values, Sessions, No Food Logs","Talk, Accept, Motivation through Values, Sessions, Short-Term Food Logs","Talk, Change, Motivation Through Values, Sessions, Long-Term Food Logs","Talk, Change, Motivation Through Values, Sessions, No Food Logs","Talk, Change, Motivation through Narratives, Check-Ins, Long-Term Food Logs","Talk, Change, Motivation through Narratives, Sessions, No Food Logs","Talk, Change, Motivation through Narratives, Sessions, Short-Term Food Logs","Talk, Change, Motivation through Values, Check-Ins, No Food Logs","Talk, Change, Motivation through Values, Check-Ins, Short-Term Food Logs",[61],{"measure":62,"description":63,"timeFrame":64},"Weight maintenance","Measured via rate of weight loss (in lbs) following discharge from inpatient unit","6-month end of treatment",[66,69,72,75,78],{"measure":67,"description":68,"timeFrame":64},"Habit strength","Measured via Self-Report Habit Index (SRHI)",{"measure":70,"description":71,"timeFrame":64},"Weight\u002Fshape distortion","Measured via Eating Disorder Examination, Questionnaire Version (EDE-Q)",{"measure":73,"description":74,"timeFrame":64},"Intrinsic motivation","Measured via General Self-Efficacy Scale (GSES)",{"measure":76,"description":77,"timeFrame":64},"Dietary restriction","Measured via Food Choice Task",{"measure":79,"description":80,"timeFrame":64},"Skill consolidation","Measured via platform utilization time","ALL","18 Years","60 Years",false,{"inclusion":86,"exclusion":91,"raw_text":98},[87,88,89,90],"Diagnosis of Anorexia Nervosa at hospital admission","Medically Stable","Internet capability with videoconferencing","Weight restored (BMI \\> 19 kg\u002Fm2) at New York State Psychiatric Institute",[92,93,94,95,96,97],"Current substance use or other comorbid disorder requiring specialized treatment","Pregnancy","Imminent risk of suicide","Serious medical illness","Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)","Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.","Inclusion Criteria:\n\n* Diagnosis of Anorexia Nervosa at hospital admission\n* Medically Stable\n* Internet capability with videoconferencing\n* Weight restored (BMI \\> 19 kg\u002Fm2) at New York State Psychiatric Institute\n\nExclusion Criteria:\n\n* Current substance use or other comorbid disorder requiring specialized treatment\n* Pregnancy\n* Imminent risk of suicide\n* Serious medical illness\n* Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)\n* Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist.",[100],"ADULT",[102],{"facility":13,"status":8,"city":103,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":114},"New York","10032","United States",[107,112],{"name":108,"role":109,"phone":110,"email":111},"Joanna Steinglass, MD","CONTACT","6467746345","js1124@cumc.columbia.edu",{"name":108,"role":113},"PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},40.71427,-74.00597,[118],{"name":108,"role":109,"phone":119,"email":111},"646-774-6345",[],[122],{"pmid":123,"type":124,"citation":125},"35488866","BACKGROUND","Steinglass JE, Attia E, Glasofer DR, Wang Y, Ruggiero J, Walsh BT, Thomas JG. Optimizing relapse prevention and changing habits (REACH+) in anorexia nervosa. Int J Eat Disord. 2022 Jun;55(6):851-857. doi: 10.1002\u002Feat.23724. Epub 2022 Apr 30.",[],{"nct_id":4,"conditions":128,"biomarkers":129},[19],[],{"nct_id":4,"found":84,"summary":15,"prompt_version":15}]