[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448375":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":27,"studyPopulation":18,"armGroups":28,"interventions":43,"overallOfficials":18,"centralContacts":62,"locations":68,"responsibleParty":88,"collaborators":90,"id":94,"slug":18,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":18,"eligibilityCriteria":98,"healthyVolunteers":95,"sex":99,"minAge":100,"maxAge":18,"enrollmentInfo":101,"targetDuration":18,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"HabitAware Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Clinician-rated trichotillomania (TTM) symptom severity at endpoint (week 8)","Scores on the NIMH Trichotilomania Severity Scale (NIMH-TSS), a clinician-administered assessment of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. The NIMH-TSS is a 5-item clinician rated measure of TTM severity ranging from 0-25, with higher scores indicating more severe symptoms.","Eight weeks",[14],{"measure":15,"description":16,"timeFrame":17},"Self-reported trichotillomania (TTM) severity at endpoint (week 8)","Scores on the Massachusetts General Hospital Hair Pulling Scale (MGH-HS), a validated and widely used 7-item Likert self-report measure of TTM symptom severity, will be compared across conditions at endpoint (week 8), controlling for baseline severity. MGH-HS scores range from 0 to 28, with higher scores corresponding with more severe TTM symptoms.","8 weeks",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":25},"SINGLE",[26],"OUTCOMES_ASSESSOR","Trichotillomania is characterized by recurrent hair pulling despite repeated attempts to stop, resulting in hair loss as well as significant distress and impairment. Behavior therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior (i.e., competing response) and other behavioral strategies (e.g., stimulus control) are efficacious. In this randomized control trial, we are testing the preliminary efficacy of two digital health interventions for adults with TTM (N=90). Participants will be randomly assigned (50\u002F50 chance) to receive 8 weeks of (a) a digital behavior therapy that includes a wrist worn motion detection device to enhance awareness and a companion mobile application that provides psychoeducation, awareness training (e.g., self-monitoring), and behavioral strategy suggestions or (b) a digital general wellness intervention that includes a reminder bracelet (i.e., a wrist-worn visual reminder not to pull) accompanied by a smartphone app that includes general context logging and delivery of general health tips.",[29,36],{"label":30,"type":31,"description":32,"interventionNames":33},"Keen2 bracelet and app","EXPERIMENTAL","8-week intervention involving a wrist-worn motion detection device (Keen2 bracelet) and accompanying smartphone app that delivers components of behavior therapy for TTM.",[34,35],"Device: Keen2 bracelet","Behavioral: Keen2 app",{"label":37,"type":38,"description":39,"interventionNames":40},"Reminder bracelet and health tips app","PLACEBO_COMPARATOR","8-week intervention involving a wrist-worn reminder device (non-vibrating bracelet) and accompanying smartphone app that prompts for general context logging and delivers general health tips.",[41,42],"Device: Reminder bracelet","Behavioral: Health Reminders App",[44,49,53,58],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":18},"DEVICE","Keen2 bracelet","Participants will receive an awareness bracelet (Keen2) which vibrates upon detection of hair pulling motion, supporting behavior therapy for hair pulling delivered by the Keen2 app.",[30],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":18},"Reminder bracelet","Participants will receive a non-vibrating bracelet to wear as a visual reminder not to pull.",[37],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":18},"BEHAVIORAL","Keen2 app","Participants will be given access to a smartphone app. The bracelet and app work together to implement key features of habit reversal training for TTM, including psychoeducation, awareness training, competing response training, and personalized just-in-time stimulus control and other behavioral strategy reminders.",[30],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":18},"Health Reminders App","Participants will be given access to a smartphone app that will prompt them to log their context (e.g., location and activity) throughout the day and provide general health tips.",[37],[63],{"name":64,"role":65,"phone":66,"phoneExt":18,"email":67},"Sameer Kumar, BS","CONTACT","248-990-4720","sameer@habitaware.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Department of Psychological Sciences","RECRUITING","Kent","Ohio","44242","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-81.35789,41.15367,{"lat":81,"lon":80},[84],{"name":85,"role":65,"phone":86,"phoneExt":18,"email":87},"Christopher Flessner, PhD","(330) 672-2200","anxiety@kent.edu",{"type":89,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[91],{"name":92,"class":93},"Kent State University","OTHER","100448375",false,"NCT05118633","Technology Assisted Treatment for Trichotillomania","Inclusion Criteria:\n\n1. 18 years of age or older (criterion 1a) with a diagnosis of TTM focused on primary hair pulling location(s) above the neck (e.g., scalp, eyebrows, eye lashes, beard) (criterion 1b).\n2. English language fluency (criterion 2).\n3. Report no current pharmacological intervention targeting TTM symptoms OR a 6-week course of the intervention without change in dosage and intent for that dosage to remain stable for the 12 weeks of this trial (criterion 3a).\n4. Report no current psychosocial intervention targeting TTM (criterion 3b)\n\n4\\. Reliable and consistent access to the internet and\u002For mobile device permitting the participant to meet with someone virtually for 90 min.\n\n5\\. Owns a mobile phone running on Apple's operating system (iOS 6+) 6. Identifies a support person that is able to be contacted if an emergency arises.\n\nExclusion Criteria:\n\n1. Current suicidal\u002Fhomicidal ideation, intent, or plan (criterion 1a) or a diagnosis of another psychiatric condition that may impede a participant's ability to fully utilize the app (e.g., psychotic disorder, eating disorder, moderate to severe major depressive disorder \\[defined by meeting diagnostic criteria on the MINI and a score \\>13 on DASS-21\\]) (criterion 1b)\n2. Has not used HabitAware's Keen or Keen2 bracelet in the past 24 months.\n3. Residing outside the United States","ALL","18 Years",{"count":102,"type":103},90,"ESTIMATED","INTERVENTIONAL",[106],"NA","The investigators are testing two digital health interventions for trichotillomania (TTM), via a randomized trial design.",[109],"Trichotillomania",[111,112,109,113],"Hair Pulling Disorder","Body-Focused Repetitive Behaviors","habit reversal training","2026-05-29",{"date":116,"type":117},"2026-06-02","ACTUAL",{"date":119,"type":117},"2026-05-15",{"date":121,"type":103},"2026-12-31",{"name":5,"class":6},1]