[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07221383":3,"trial-entities:NCT07221383":111,"trial-summary:NCT07221383":115},{"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":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":66,"sex":77,"minimum_age":78,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":92,"locations":95,"central_contacts":104,"overall_officials":105,"references":109,"see_also_links":110},"NCT07221383","2000040798","LDART for Alcohol Use Disorder","A Pilot Randomized Controlled Trial of LDART, a Social Support Intervention for Alcohol Use Disorder","ENROLLING_BY_INVITATION","2027-04-01","2026-04","2026-05-01","2026-04-29","Yale University","OTHER",false,"This study is a pilot randomized controlled trial to evaluate feasibility, acceptability, and preliminary efficacy of a digital intervention called Let's Do Addiction Recovery Together! (LDART) in adults with alcohol use disorder, relative to a control group.",null,[19,20],"Alcohol Use Disorder","Hazardous Alcohol Use",[22,23,24,25,26,27],"social support","digital intervention","mutual-help groups","alcohol use disorder","addiction recovery","peer support","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},80,"ESTIMATED",[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","LDART","Let's Do Addiction Recovery Together! (LDART) is a web-based intervention grounded in social cognitive theory that is designed to reduce hazardous alcohol use. It has three active ingredients: 1) daily recovery goal setting and tracking, 2) motivational video, audio, and written messages from individuals in recovery, and 3) information on several community-based recovery groups (e.g., mutual-help groups, recovery community centers) that provide free, publicly available meetings and activities. Participants receive a text message reminder each night to go to the website to complete the activities, and a text message reminder each morning of the goal they set for themselves, with the option to change it. It only takes a few minutes to use LDART each day over the 4-week intervention period.",[38],{"type":42,"name":43,"description":44,"armGroupLabels":45},"BEHAVIORAL","Psychoeducational control","This is a 20-page psychoeducational booklet created by the National Institute on Alcohol Abuse \\& Alcoholism (NIAAA) called \"Rethinking Drinking\". It contains several suggestions, strategies and resources for helping people who want to reduce their alcohol use. Participants will be encouraged to access the booklet for a few minutes each night over the 4-week intervention period.",[46],"Rethinking Drinking",[48,52,55,58,62],{"measure":49,"description":50,"timeFrame":51},"Recruitment rate","The percentage of eligible participants who are enrolled relative to the total number of eligible potential participants who completed the screening.","From enrollment to the final assessment time point (Day 56)",{"measure":53,"description":54,"timeFrame":51},"Accrual rate","The rate of enrollment, defined as number of participants enrolled per month.",{"measure":56,"description":57,"timeFrame":51},"Retention rate","The percentage of enrolled participants who complete all study-related procedures (i.e., assessments at 3 monthly time points).",{"measure":59,"description":60,"timeFrame":61},"Intervention engagement","Number of nights that participants in the active condition completed the activities on the LDART website, out of 28 nights.","From beginning the intervention (Day 1) to the end of the intervention period (Day 28)",{"measure":63,"description":64,"timeFrame":65},"Intervention acceptability","Rating scores on the end-user version of the Mobile App Rating Scale (uMARS). Total score range 1-5 with higher scores indicating a better quality app.","The second assessment time point (post-intervention, Day 28)",[67,71,74],{"measure":68,"description":69,"timeFrame":70},"Change from baseline in number of drinking days","Change in self-reported number of drinking days in the past 28 days, as measured using the Timeline Follow-back.","Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)",{"measure":72,"description":73,"timeFrame":70},"Change from baseline in number of heavy drinking days","Change in self-reported number of heavy drinking days (defined as 4 or more drinks for women or 5 or more drinks for in one sitting) in the past 28 days, as measured using the Timeline Follow-back.",{"measure":75,"description":76,"timeFrame":70},"Change from baseline in number of hours spent engaging with recovery groups","Self-reported number of hours spent engaging with recovery groups in the past 28 days","ALL","18 Years",{"inclusion":80,"exclusion":86,"raw_text":91},[81,82,83,84,85],"Currently reside in Connecticut, USA","Have a smartphone that can send and receive text messages and have internet access that can be access over the course of a month","Had ≥5 heavy drinking days (defined as ≥4 or ≥5 drinks in one sitting for women and men, respectively) in the past 28 days","Alcohol Symptom Checklist ≥4, indicating moderate\u002Fsevere AUD","Have some self-reported desire to cut down or quit drinking",[87,88,89,90],"Unable to provide informed consent, as assessed by the consent quiz","Unable to speak, read, or write in English","Vulnerable population status","Unlikely to be able to complete study procedures in the next 2-3 months","Inclusion Criteria:\n\n* Currently reside in Connecticut, USA\n* Have a smartphone that can send and receive text messages and have internet access that can be access over the course of a month\n* Had ≥5 heavy drinking days (defined as ≥4 or ≥5 drinks in one sitting for women and men, respectively) in the past 28 days\n* Alcohol Symptom Checklist ≥4, indicating moderate\u002Fsevere AUD\n* Have some self-reported desire to cut down or quit drinking\n\nExclusion Criteria:\n\n* Unable to provide informed consent, as assessed by the consent quiz\n* Unable to speak, read, or write in English\n* Vulnerable population status\n* Unlikely to be able to complete study procedures in the next 2-3 months",[93,94],"ADULT","OLDER_ADULT",[96],{"facility":13,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"New Haven","Connecticut","06520","United States",{"lat":102,"lon":103},41.30815,-72.92816,[],[106],{"name":107,"affiliation":13,"role":108},"Li Yan McCurdy, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Alcohol use disorder",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":126},true,{"design":118,"status":119,"heading":6,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a pilot randomized controlled trial, meaning participants will be randomly assigned to either the LDART program or the \"Rethinking Drinking\" booklet. The study plans to enroll 80 participants.","completed","This study is testing a new web-based program called Let's Do Addiction Recovery Together! (LDART) for adults who want to reduce their alcohol use. LDART helps you set and track daily recovery goals and provides motivational messages. You would be compared to a group receiving a booklet called \"Rethinking Drinking\" from the National Institute on Alcohol Abuse & Alcoholism. This study aims to see if LDART is practical, acceptable, and shows early signs of helping people. You might be able to join if you are 18 or older, live in Connecticut, have a smartphone with internet, and have had at least 5 heavy drinking days in the past month. The study will look at how many people join, how quickly, and how many stay in the study for 56 days.","Participants will be followed until the final assessment at Day 56.",130,"The study involves participating in an intervention (LDART or a psychoeducational booklet) and assessments over a period of 56 days.","Not stated in the trial record.",[38],"v2"]