[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625899":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":46,"interventions":53,"overallOfficials":38,"centralContacts":59,"locations":65,"responsibleParty":83,"collaborators":38,"id":87,"slug":38,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":38,"enrollmentInfo":95,"targetDuration":38,"studyType":98,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":67,"whyStopped":38,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Dartmouth-Hitchcock Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":38},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Retention","Measured based on the percentage of participants who complete the full study.","Baseline, 8 weeks",{"measure":14,"description":15,"timeFrame":16},"Recruitment rate","Recruitment rate will be based on the average number of participants who are enrolled into the trial per month.","From study initiation until we are no longer actively recruiting (approximately 3 months)",{"measure":18,"description":19,"timeFrame":20},"Acceptability","Visit completion will be based the number of visits (out of 5) completed by each participant.","8 weeks",{"measure":22,"description":23,"timeFrame":24},"Treatment acceptability questionnaire score","The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.","1 week",[26,29,32,35],{"measure":27,"description":28,"timeFrame":12},"Change in insomnia symptoms as measured by the Insomnia Severity Index","The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.",{"measure":30,"description":31,"timeFrame":12},"Change in diary-based sleep onset latency","A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary",{"measure":33,"description":34,"timeFrame":12},"Change in diary-based wake after sleep onset","A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary",{"measure":36,"description":37,"timeFrame":12},"Change in diary-based sleep efficiency","Change in sleep efficiency (total sleep time \u002F time in bed), derived from a self-reported sleep diary.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"NA","SINGLE_GROUP","Longitudinal","TREATMENT",{"masking":45,"maskingDescription":38,"whoMasked":38},"NONE",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"CBT-I UC Treatment","EXPERIMENTAL","All participants entered into the study will receive telehealth CBT-I for UC.",[52],"Behavioral: CBT-I UC",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":38},"BEHAVIORAL","CBT-I UC","This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.",[48],[60],{"name":61,"role":62,"phone":63,"phoneExt":38,"email":64},"Jessica K Salwen-Deremer, PhD","CONTACT","(603) 650-5261","jessica.k.salwen-deremer@hitchcock.org",[66],{"facility":5,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Lebanon","New Hampshire","03756","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-72.25176,43.64229,{"lat":77,"lon":76},[80],{"name":81,"role":62,"phone":82,"phoneExt":38,"email":64},"Jessica Salwen-Deremer, PhD","603-650-6388",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Jessica.K.Salwen-Deremer","Assistant Professor of Psychiatry","100625899",false,"NCT07428629","Piloting an Insomnia Treatment in Patients With Ulcerative Colitis","RISE-UC","Inclusion Criteria:\n\n* Active UC based on PRUCSI\n* Insomnia Severity Index score \\> 8 and SOL or WASO \\> 30 minutes\n* Stability of sleep \\& UC meds for \\> 3 months\n* Access to internet or cell phone service sufficient for telehealth\n\nExclusion Criteria:\n\n* PHQ-9 depression score \\> 15\n* GAD-7 anxiety score \\> 15\n* Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)\n* Current alcohol or substance abuse\n* Current opioid use for pain control\n* Current systemic corticosteroid use\n* Current pregnancy or nursing\n* Ileostomy or colostomy\n* Diagnosis of seizure disorder\n* Diagnosis of sleep apnea\n* Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen\n* Night shift, rotating shift work, or frequent travel outside of time zone\n* Residence in a state where we cannot conduct telehealth visits","ALL","18 Years",{"count":96,"type":97},20,"ESTIMATED","INTERVENTIONAL",[40],"The goal of this clinical trial is to learn if telehealth-based Cognitive Behavioral Therapy for Insomnia (CBT-I) adapted for Ulcerative Colitis (UC) works to treat insomnia in adults with UC. The main questions it aims to answer are:\n\n* Is telehealth-based CBT-I adapted for UC feasible and acceptable to participants?\n* Does CBT-I for UC impact insomnia severity and sleep continuity?\n\nParticipants will:\n\n* Answer questionnaires online before and after treatment\n* Complete an online daily sleep diary before, during, and after treatment\n* Participate in 5 telehealth treatment visits over 7-8 weeks\n* Participate in 5-10-minute phone calls between treatment visits",[102,103],"Insomnia","Ulcerative Colitis",[105],"telehealth","2026-04-29",{"date":108,"type":109},"2026-05-05","ACTUAL",{"date":111,"type":109},"2026-04-17",{"date":113,"type":97},"2026-09-01",{"name":5,"class":6},1]