[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07673380":3,"trial-entities:NCT07673380":108,"trial-summary:NCT07673380":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":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":50,"sex":68,"minimum_age":69,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":81,"locations":84,"central_contacts":99,"overall_officials":105,"references":106,"see_also_links":107},"NCT07673380","202308065","Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City","Leveraging mHealth to Promote Recovery From Opioid Use Disorder and Commonly Occurring Mental Health Disorders Among Residents of a Medium-Sized Midwestern City","RECRUITING","2027-02-28","2026-06","2026-06-29","2025-08-31","Washington University School of Medicine","OTHER",false,"The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment. Participants are recruited from community-based substance use treatment facilities and recovery services. Participants must be adults who have or are currently using opioids and\u002For stimulants.",null,[19,20,21],"Opioid Use","Stimulant Use","Depression and Anxiety Symptoms",[23,24],"Digital health","Community engagement","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"PHASE2",{"count":30,"type":31},300,"ESTIMATED",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","uMAT-R + enhanced community engagement","uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. This involves in-person interactions with eligible participants and recruitment sites.",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Original uMAT-R supplementary mHealth recovery intervention","uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.",[39],[43,47],{"measure":44,"description":45,"timeFrame":46},"Abstinence\u002F Changes in Substance Use","Frequency of opioid use, stimulant, and\u002For other substance use (e.g., discordant with prescribed usage) or other substances (e.g., stimulants, other non-opioid illicit drugs) in the past 30-day will be assessed by items from the National Survey on Drug Use and Health (NSDUH) questionnaire. The score indicates days on using any substance listed above over past 30-day, ranging from 0 to 30, with a higher score reflecting more frequent substance use.","Time 0 (Baseline) and Time 1 (One Month)",{"measure":48,"description":49,"timeFrame":46},"Opioid use\u002F Stimulant use disorder symptoms","The number of DSM-5-TR diagnostic criteria met for opioid use disorder (OUD) and stimulant use disorder (StUD) will be assessed. Scores range from 0 to 11, with higher scores indicating that more diagnostic criteria are met for the disorder.",[51,55,58,61,65],{"measure":52,"description":53,"timeFrame":54},"Depression symptoms","The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression symptoms. The potential scale scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Continuous variables will be created to assess the total scores at baseline and the 1-month follow-up, respectively.","Time 0 (Baseline) and Time 1 (One-Month)",{"measure":56,"description":57,"timeFrame":54},"Anxiety Symptoms","The Generalized Anxiety Disorder Assessment-7 (GAD-7) will be used to assess anxiety symptoms. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), allowing for a comprehensive evaluation of anxiety symptoms in the past 2 weeks, such as 'Feeling nervous, anxious, or on edge' or 'Becoming easily annoyed or irritable...' The potential scale scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. To examine the changes in GAD-7 scores from baseline to the 1-month follow-up, continuous variables will be created to assess the scores at the respective time points.",{"measure":59,"description":60,"timeFrame":54},"Basic needs","The adapted Wellbeing and Basic Needs Survey will be used to assess confidence in meeting their basic needs. Participants were asked to rate their confidence in meeting their basic needs on a Likert scale ranging from \"very confident\" (1) to \"not confident at all\" (8). To examine changes in scores continuous variables were created to capture the baseline and 1-month follow-up scores, respectively. Scores may range from 8 to 64, which higher scores indicating less confidence in attending to basic needs.",{"measure":62,"description":63,"timeFrame":64},"Medication for Opioid Use Disorder (MOUD) Attitudes","We will measure Medication for Opioid Use Disorder (MOUD) attitudes using an 8-item subscale to evaluate participants' attitudes towards MOUD modified from the Attitudes of Methadone Scale. Participants will provide responses on a 5-point Likert scale, ranging from 'strongly disagree' (1) to 'strongly agree' (5). Sample items include: 'Taking MOUD is only replacing one addiction with another,' 'A person is better off taking MOUD than opioids,' and 'MOUD is as dangerous as opioids.' The total score will be calculated by summing all items, resulting in a potential scoring range of 8 to 40 with higher scores indicating greater negative attitudes toward MOUD use.","Time 0 (Baseline), and Time 1 (One-Month)",{"measure":66,"description":67,"timeFrame":64},"Substance Use Disorder (SUD) Treatment Engagement","Participants will be asked if they are enrolled and receive specialty substance use care, and\u002For medication for Opioid Use Disorder, assessed by self-report. \"Are you currently enrolled in a treatment plan or program for substance use care?\" \"Are you currently being prescribed medication for opioid use disorder (MOUD)\"\n\nResponse options will include \"yes\" or \"no.\" If a participant responds \"yes\" to at least one question, the final outcome for substance use treatment engagement will be coded as \"yes.\" \"No\" responses to both questions will be coded as \"No.\"","ALL","18 Years",{"inclusion":71,"exclusion":78,"raw_text":80},[72,73,74,75,76,77],"Have a history of opioid and\u002For stimulant use","Identify as Black and\u002For African American","Seek treatment at local substance use treatment centers","Fluent in English","U.S. resident","18 years of age or older at the time of data collection.",[79],"Self-reported cognitive impairment that would limit ability to participate in research.","Inclusion Criteria:\n\n* Have a history of opioid and\u002For stimulant use\n* Identify as Black and\u002For African American\n* Seek treatment at local substance use treatment centers\n* Fluent in English\n* U.S. resident\n* 18 years of age or older at the time of data collection.\n\nExclusion Criteria:\n\n* Self-reported cognitive impairment that would limit ability to participate in research.",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"St Louis","Missouri","63110","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Hannah Szlyk, PhD","CONTACT","917-836-4225","szlyk@wustl.edu",{"lat":97,"lon":98},38.62727,-90.19789,[100,102],{"name":101,"role":93,"phone":94,"email":95},"Hannah Szlyk",{"name":103,"role":93,"email":104},"Elecia Worley","e.m.worley@wustl.edu",[],[],[],{"nct_id":4,"conditions":109,"biomarkers":114},[110,111,112,113],"Anxiety symptoms","Opioid Use Disorder","Stimulant use disorder","Symptoms of depression",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This interventional study compares two versions of a mobile health program (uMAT-R and uMAT-R + enhanced community engagement) in 300 participants. It is a sequential trial, meaning the interventions are compared in a specific order.","completed","mHealth for Opioid and Stimulant Recovery in Black\u002FAfrican American Adults","This study is looking at how a mobile health (mHealth) program called uMAT-R can help Black and African American adults who are recovering from opioid or stimulant use. Researchers want to see if adding extra community engagement (in-person interactions) to the uMAT-R program, called uMAT-R + enhanced community engagement, works better than the original uMAT-R program alone. The goal is to improve recovery and mental health, including symptoms of depression and anxiety. To join, you must be 18 or older, identify as Black or African American, have a history of opioid and\u002For stimulant use, and be seeking treatment at local centers. The study will measure changes in substance use and symptoms of opioid\u002Fstimulant use disorder after one month to see if the interventions are successful. The study aims to enroll 300 participants.","Participants will be followed for one month after starting the intervention.",132,"Participants will engage with the uMAT-R mobile health intervention, potentially with enhanced community engagement. Substance use and disorder symptoms will be measured at the start and after one month.","Not stated in the trial record.",[35],"v2"]