[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389902":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":66,"collaborators":70,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":24,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychological treatment","EXPERIMENTAL","The psychological treatment consists of 11 sessions (55 minutes per occasion), where the patient meets a psychologist face-to-face (either licensed or under training to be licensed) once a week. In between sessions, patients are supposed to complete homework exercises that are related to the contiguous sessions (2 x 45 minutes per week).",[13],"Behavioral: Psychological treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Cognitive training","ACTIVE_COMPARATOR","Like the experimental group, the active control group also consists of 11 sessions (55 minutes per occasion), once a week. At those occasions, the patient will meet a psychology student under training or a MSc in psychology that coaches the patients during the cognitive training. In between sessions, patients are supposed to take 2 walks (45 minutes per occasion to meaningfully match the home exercises in the experimental group).",[19],"Behavioral: Cognitive training",{"label":21,"type":22,"description":23,"interventionNames":24},"Treatment as usual","NO_INTERVENTION","This group receives no intervention. They receive regular health information that is given after the extended cognitive examination at the Cognitive Centers. However, after the finalization of the post-intervention evaluations, this group will be randomized to participate in one of the active interventions. We will conduct additional post-intervention assessments also for those individuals in this group that accept this offer to increase the power of the intervention evaluation.",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"BEHAVIORAL","The treatment is an adjusted (to the cognitively impaired individual) combination of CBT, ACT, validation strategies, and psychoeducation. One focus is to increase motivation to lifestyle changes, and to a larger degree live life in correspondence with internal goals.",[9],{"type":27,"name":15,"description":31,"armGroupLabels":32,"otherNames":24},"Computer based training tasks implemented with adaptive intensity. The cognitive training method that will be used is mainly related to executive control (i.e., ability to coordinate thoughts and actions in accordance with internal goals).",[15],[34],{"name":35,"affiliation":5,"role":36},"Miia Kivipelto, Professor","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":24,"email":42},"Urban Ekman, PhD","CONTACT","+468-517 713 66","urban.ekman@ki.se",{"name":44,"role":40,"phone":45,"phoneExt":24,"email":46},"Måns Gyllenhammar, PhD student","+468-52483557","mans.gyllenhammar@ki.se",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Karolinska University Hospital","RECRUITING","Stockholm","Stockholm County","17164","Sweden","SE",{"type":57,"coordinates":58},"Point",[59,60],18.06871,59.32938,{"lat":60,"lon":59},[63,64],{"name":39,"role":40,"phone":24,"phoneExt":24,"email":42},{"name":44,"role":40,"phone":24,"phoneExt":24,"email":65},"mans.gyllenhammar@regionstockholm.se",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Urban Ekman","Assistant Professor",[71],{"name":49,"class":6},"100389902","psychological-treatment-to-support-the-consequences-of-cognitive-impairment-100389902",false,"NCT04356924","Psychological Treatment to Support the Consequences of Cognitive Impairment","Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI)","* Criteria's for inclusion\n* \\\u003C 75 years.\n* SCD or MCI diagnosis. All cognitive MCI-subtypes are eligible.\n* Mild to moderate psychological symptoms that are indicated to be related to the patient's CI. The psychological symptoms should affect the patients daily living and behavior, exemplified by avoidance behavior, social anxiety and perceived stigmatization.\n* Fluency in the Swedish language.\n* The patients should have access to a mobile telephone to be able to receive reminders via Short Message Service (SMS).\n* Signed informed consent.\n* Criteria's for exclusion\n* Dementia diagnosis and\u002For occurrence of serious illness and\u002For injury that requires immediate investigation or treatment of another type, or which is expected to worsen in the coming year (i.e., not including dementia)\n* Severe psychiatric comorbidity (e.g., high suicide risk), and\u002For severe psychiatric disorder. This will be assessed in the MINI evaluation and during the clinical cognitive examination).\n* Anti-depressant medication introduced or alterations in dosage \\\u003C 6 months ago (i.e., un-stable dose).\n* Mini Mental State Examination (MMSE) score \\\u003C 26 and\u002For a Montreal Cognitive Assessment (MoCA) score \\\u003C 24.\n* Stroke or head trauma \\\u003C 6 months ago.\n* Substance abuse","ALL","45 Years","75 Years",{"count":83,"type":84},138,"ESTIMATED","INTERVENTIONAL",[87],"NA","The burden of cognitive impairment is severe, and often hinders affected people to act independently in daily life. Individuals in different stages of cognitive decline are frequently affected by existential distress and associated health issues (such as stress symptoms, anxiety, and depression), as well as social avoidance due to the unclear prognosis. Although the need for psychological support is large, there is a lack of efficient individualized psychological treatments- and methods to maintain psychological health that sufficiently impact daily life and promote behavioral- and biological change. In keeping with that notion, the investigators have developed a novel psychological treatment manual focused on supporting individuals with early phase cognitive impairment. The treatment manual is centered on facilitating behavioral change in accordance with personal values and long-term goals even in the presence of negative experiences, as well as to promote meaningful life-style changes. Conceptually, the treatment manual has its basis in the cognitive behavioral therapy (CBT) tradition, but the investigators have strived to adapt the manual to suit a cognitively affected population. The investigators will evaluate the psychological treatment in a RCT were the investigators will include approximately 138 individuals in their early phases of cognitive decline and randomize them into either an experimental group (psychological treatment), an active control group (cognitive training), or a treatment as usual control group. Evaluations will be conducted with, psychological health measures, cognitive assessments, and with biological markers.\n\nThe investigators hypothesize that in comparison with the control conditions, the response to psychological treatment will be associated with improved psychological health and improved cellular protection.",[90,91,92,93],"Cognitive Impairment","Psychological","Psychotherapy","Health Behavior",[95,9,96],"Cognitive impairment","Dementia prevention","2025-06-26",{"date":99,"type":100},"2025-07-01","ACTUAL",{"date":102,"type":100},"2023-09-07",{"date":104,"type":84},"2028-06-30",{"name":5,"class":6},1]