[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540672":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":54,"interventions":81,"overallOfficials":87,"centralContacts":91,"locations":100,"responsibleParty":117,"collaborators":120,"id":130,"slug":43,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":43,"eligibilityCriteria":134,"healthyVolunteers":131,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":43,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":103,"whyStopped":43,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"High-risk alcohol use (yes\u002Fno)","Drinking over 120 gram ethanol in seven days (determined by outcomes 4 \\& 5 )","Assessed at 12 weeks after baseline, alcohol use through the past seven days",[14,18,22,26,29,32,35,39],{"measure":15,"description":16,"timeFrame":17},"WHOQOL-Bref (The World Health Organization Quality of Life Brief Version )","Quality of life, functioning. Higher scores represent higher quality of life.","Assessed at 12 weeks after baseline",{"measure":19,"description":20,"timeFrame":21},"OBSESSIVE-COMPULSIVE DRINKING SCALE (OCDS)","Degree of compulsive alcohol use, with higher scores representing a higher degree","Through the past seven days, assessed at 12 weeks after baseline",{"measure":23,"description":24,"timeFrame":25},"Drinker Inventory of Consequences (DrInC-2R)","Consequences of drinking, a higher score represents greater consequences","Through the past 14 days, assessed at 12 weeks after baseline",{"measure":27,"description":28,"timeFrame":12},"Frequency of alcohol use","Measured in number of days",{"measure":30,"description":31,"timeFrame":12},"Amount of alcohol use","Measured in standard drinks with one drink equivalent to 12 gram pure ethanol",{"measure":33,"description":34,"timeFrame":12},"Heavy drinking days","Count, number of days with 5 or more standard drinks",{"measure":36,"description":37,"timeFrame":38},"User evaluation (tailor-made)","Subjective evaluation of user-friendliness, quality of the messages, and cultural adaptation (participants rate the intervention on a scale from 0= do not agree at all through 6= fully agree). Participants also tick off boxes for simple questions on other help received in the study period and on their impressions of the language and cultural appropriateness.","Assessed at 12 weeks after baseline, through 12 weeks (the intervention period)",{"measure":40,"description":41,"timeFrame":42},"PHQ-9 (Patient Health Questionnaire-9 )","A higher score represents a greater degree of depressive symptoms","Assessed at 12 weeks after baseline, through the past 14 days",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","PARALLEL","Participants are assigned to either one out of six intervention conditions with different types of text messaging (including one assessment-only control condition).","PREVENTION",{"masking":50,"maskingDescription":51,"whoMasked":52},"SINGLE","Participants are informed in the study material that they are allocated to groups that receive different text messages. They receive no further information on the intervention groups.",[53],"PARTICIPANT",[55,61,65,69,73,77],{"label":56,"type":57,"description":58,"interventionNames":59},"Gain-framed","EXPERIMENTAL","One daily text-message and weekly alcohol use assessment. The text-messages focus on the positive consequences of drinking less.",[60],"Behavioral: Text messaging",{"label":62,"type":57,"description":63,"interventionNames":64},"Loss-framed","One daily text-message and weekly alcohol use assessment. The text-messages focus on the negative consequences of a high alcohol-intake.",[60],{"label":66,"type":57,"description":67,"interventionNames":68},"Static-tailored","One daily text-message and weekly alcohol use assessment. The text-messages are adapted to the participant's gender and to baseline information on (e.g.) participants' drinking patterns, social network, and self-efficacy. One message per week is adapted to the day on which the participants find it most challenging to reduce their drinking.",[60],{"label":70,"type":57,"description":71,"interventionNames":72},"Adaptive-tailored","One daily text-message and weekly alcohol use assessment. The text-messages are adapted to the participant's gender and to baseline information on (e.g.) participants' drinking patterns, social network, and self-efficacy. One message per week is adapted to the day on which the participants find it most challenging to reduce their drinking. In addition, text messages are adapted to the weekly alcohol-assessment over time and participants can demand supportive Just-In-Time messages.",[60],{"label":74,"type":57,"description":75,"interventionNames":76},"Combined","This arm combines all features of the arms Adaptive-tailored and Gain-framed.",[60],{"label":78,"type":79,"description":80,"interventionNames":43},"Assessment-only","NO_INTERVENTION","The control group. Participants do only receive 4 questions on their alcohol intake once a week.",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":43},"BEHAVIORAL","Text messaging","Participants receive text messages related to their alcohol consumption.",[70,74,56,62,66],[88],{"name":89,"affiliation":5,"role":90},"Silke Behrendt, PhD","PRINCIPAL_INVESTIGATOR",[92,96],{"name":89,"role":93,"phone":94,"phoneExt":43,"email":95},"CONTACT","+4593507195","sbehrendt@health.sdu.dk",{"name":97,"role":93,"phone":98,"phoneExt":43,"email":99},"Anette S Nielsen, PhD","0045 29 13 58 25","ansnielsen@health.sdu.dk",[101],{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"University of Southern Denmark, Department of Psychology","RECRUITING","Odense","Southern Denmark","5230","Denmark","DK",{"type":110,"coordinates":111},"Point",[112,113],10.38831,55.39594,{"lat":113,"lon":112},[116],{"name":89,"role":93,"phone":43,"phoneExt":43,"email":95},{"type":90,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Silke Behrendt","Professor",[121,124,126,128],{"name":122,"class":123},"Anette Søgaard Nielsen, PhD","UNKNOWN",{"name":125,"class":123},"Kjeld Andersen, PhD",{"name":127,"class":123},"Angelina Mellentin, PhD",{"name":129,"class":123},"Alexis Kuerbis","100540672",false,"NCT06319885","Text Messaging to Reduce High-risk Alcohol Use Among Older Adults","Inclusion Criteria:\n\n* consumption of \\> 10 standard drinks á 12 gram ethanol per week (i.e., high-risk alcohol use defined by the Danish Health Authority) in the past four weeks\n* desire to reduce drinking\n* age 55 to 80 years\n* mobile phone ownership and willingness to receive and respond to text messages\n* fluency in Danish.\n\nExclusion Criteria:\n\n* drinking more than 53 standard drinks per week in the last four weeks\n* past 12 month alcohol withdrawal symptoms or lifetime history of serious withdrawal symptoms (e.g., seizures)\n* score above 12 on the Short alcohol withdrawal scale; SAWS\n* possible drug dependence (i.e., use of illegal drugs or psychotropic medication taken without prescription more than once a month)\n* indication of serious psychiatric illness (lifetime diagnosis of psychosis or bipolar disorder, inpatient treatment or medication for these, recent suicidality)\n* current alcohol\u002Fdrug abuse treatment or a desire to start alcohol\u002Fdrug abuse treatment during the study\n* medical condition that requires abstinence from alcohol\n* wish to achieve abstinence (applied to secure a focus on reduction)\n* lack of understanding of study protocol or reading difficulty as evidenced by a score of less than 7 out of 10 on the consent form quiz.","ALL","55 Years","80 Years",{"count":139,"type":140},60,"ESTIMATED","INTERVENTIONAL",[143],"NA","High-risk drinking is very prevalent among Danes aged 55+. It poses a serious risk to health and independent living, burdening health care systems and family members. Measures to reduce high-risk alcohol use in this growing group at need are urgently needed. A recent small study from the US shows that text messaging reduces high-risk alcohol intake in older adults. The investigators will conduct a pilot study with the same intervention in Denmark, with adaptations to language and culture. The pilot study will investigate among Danish older adults whether text messaging is well-accepted by participants and feasible in terms of reducing 1) high-risk drinking and 2) commonly accompanying problems with daily functioning, social relationships, and mental and physical health. The pilot-trial will include n=60 adults aged 55-80 years who will receive alcohol-related text messages (within a secure app for data protection purposes) over 12 weeks. Assessments will include a baseline assessment and a post-assessment.",[146],"Hazardous Alcohol Use",[148,149,150,151],"older adults","digital intervention","prevention","text messaging","2025-03-27",{"date":154,"type":155},"2025-04-02","ACTUAL",{"date":157,"type":155},"2024-04-15",{"date":159,"type":140},"2025-04-15",{"name":5,"class":6},1]