[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574995":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":46,"studyPopulation":43,"armGroups":47,"interventions":60,"overallOfficials":69,"centralContacts":73,"locations":82,"responsibleParty":101,"collaborators":104,"id":108,"slug":43,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":43,"enrollmentInfo":117,"targetDuration":43,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":130,"overallStatus":85,"whyStopped":43,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Linkoeping University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Kessler-10 (K10)","Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50.","At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Fear of Cancer Recurrence Inventory, short form (FCRI)","Measure of fear of the cancer recurring and\u002For spreading. Consists of 9 items. Higher scores indicate greater fear\u002Fanxiety levels. Scores can range between 0 and 36.","At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.",{"measure":19,"description":20,"timeFrame":17},"Generalized Anxiety Disorder-7 item scale (GAD-7)","Measure of symptoms of generalized anxiety disorder. Consists of seven items. Higher scores indicate greater anxiety. Scores can range between 0 and 21.",{"measure":22,"description":23,"timeFrame":17},"Insomnia Severity Index (ISI)","Measure of insomnia and sleep related-difficulties. Consists of seven items. Higher scores indicate greater sleep related-difficulties. Scores can range from 0 to 28.",{"measure":25,"description":26,"timeFrame":17},"Brunnsviken Brief Quality of Life Scale (BBQ)","Measure of quality of life. Consists of 12 items. Higher scores indicate a greater quality of life. Scores can range between 0 and 96.",{"measure":28,"description":29,"timeFrame":17},"The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)","Measure of health-related quality of life. Consists of 30 items and three main subscales which each will serve as an outcome: Global health status, Functional status, and Symptom status. Higher scores indicate a greater health status within the domain. Scores can range between 0 and 100.",{"measure":31,"description":32,"timeFrame":12},"The Illness Cognition Questionnaire (ICQ)","Measure of cognitions about the illness (in this case prostate cancer). Consists of 18 items. Analyzed separately as three subscales: Acceptance, Perceived benefits, and Helplessness. Greater scores indicate greater acceptance, more perceived benefits, and greater helplessness, respectively. Will also be used as mediators in a mediation analysis with the rate of change in subscale sum scores used as mediators. Sum scores for each subscale can range between 6 and 24.",[34],{"measure":35,"description":36,"timeFrame":37},"Client Satisfaction Questionnaire-8 item version (CSQ-8)","Measure of treatment satisfaction. Consists of eight items. Higher scores indicate greater treatment satisfaction. Scores can range between 8 and 32.","Measured after nine weeks of treatment.",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":43,"timePerspective":43,"maskingInfo":44},"RANDOMIZED","PARALLEL","After recruitment finished, participants will be randomized to either tailored ICBT treatment or a control condition.","TREATMENT",null,{"masking":45,"maskingDescription":43,"whoMasked":43},"NONE","Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and\u002For cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.\n\nThis study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Tailored ICBT","EXPERIMENTAL","An eight week long ICBT treatment that is tailored to the problem profile of the participant. The treatment is modular, with one module being administered per week of the treatment.",[53],"Behavioral: Internet-based cognitive behavioral therapy",{"label":55,"type":56,"description":57,"interventionNames":58},"Non-directive support","ACTIVE_COMPARATOR","The control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules.",[59],"Behavioral: Non-directive support",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":43},"BEHAVIORAL","Internet-based cognitive behavioral therapy","An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase.",[49],{"type":62,"name":55,"description":67,"armGroupLabels":68,"otherNames":43},"Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.",[55],[70],{"name":71,"affiliation":5,"role":72},"Gerhard Andersson, pHD","PRINCIPAL_INVESTIGATOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":43,"email":78},"Gerhard Andersson, Ph.D.","CONTACT","+46-13285840","gerhard.andersson@liu.se",{"name":80,"role":76,"phone":43,"phoneExt":43,"email":81},"Anton Käll, Ph.D.","anton.kall@liu.se",[83],{"facility":84,"status":85,"city":86,"state":43,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Department of Behavioral Sciences and Learning","RECRUITING","Linköping","58183","Sweden","SE",{"type":91,"coordinates":92},"Point",[93,94],15.62157,58.41086,{"lat":94,"lon":93},[97,98,99],{"name":75,"role":76,"phone":77,"phoneExt":43,"email":78},{"name":75,"role":72,"phone":43,"phoneExt":43,"email":43},{"name":80,"role":100,"phone":43,"phoneExt":43,"email":43},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Gerhard Andersson","Professor",[105],{"name":106,"class":107},"University Hospital, Linkoeping","OTHER","100574995",false,"NCT06766526","Internet-based Support for Adjustment to Prostate Cancer","Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer","ISAC","Inclusion Criteria:\n\n* Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.\n* A sum score above 19 on the primary outcome measure (Kessler-10).\n* An age of 18 or older.\n* Ability to speak, read, and write Swedish.\n* Access to a computer\u002Flaptop\u002Ftablet\u002Fsmartphone and internet access.\n* Sufficient computer profiency to be able to use the treatment platform.\n\nExclusion Criteria:\n\n* Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.\n* Recently finished (within the past six months) medical treatment for prostate cancer.\n* Severe psychiatric or somatic conditions that impedes participation in the study.\n* Ongoing substance use problems.\n* Acute suicidality.\n* Other ongoing psychological treatment.\n* Psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.","MALE","18 Years",{"count":118,"type":119},180,"ESTIMATED","INTERVENTIONAL",[122],"NA","The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.",[125,126,127,128,129],"Psychological Distress","Depression - Major Depressive Disorder","Insomnia","Anxiety","Prostate Cancer",[131,132,133,134,135],"Psychological distress","Prostate cancer","Cancer","ICBT","Cognitive behavior therapy","2025-02-21",{"date":138,"type":139},"2025-02-24","ACTUAL",{"date":141,"type":139},"2025-01-05",{"date":143,"type":119},"2026-12",{"name":5,"class":6},1]