[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658501":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":58,"studyPopulation":51,"armGroups":59,"interventions":72,"overallOfficials":82,"centralContacts":88,"locations":94,"responsibleParty":109,"collaborators":111,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":51,"eligibilityCriteria":120,"healthyVolunteers":117,"sex":121,"minAge":122,"maxAge":51,"enrollmentInfo":123,"targetDuration":51,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":138,"overallStatus":97,"whyStopped":51,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Uppsala University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Brief Mentalized Affectivity Scale (B-MAS)","Evalutates three core components of emotion regulation: \"Identifying emotions\"; \"Processing emotions\", \"Expressing emotions\".","Baseline (pre-intervention), post-treatment (10 weeks after baseline), 3-month follow-up (approximately 22 weeks after baseline), 12-month follow-up (approximately 62 weeks after baseline).",[14,18,21,24,27,30,33,36,39,42,45,48],{"measure":15,"description":16,"timeFrame":17},"Quality of Life after Brain Injury (QOLIBRI)","QOLIBRI consists of 37 items in six scales. Health-related quality of life is assessed in the areas of \"Cognition,\" \"Self,\" \"Daily Life and Autonomy,\" and \"Social Relationships,\" and feeling bothered by \"Emotions,\" and \"Physical Problems.\"","Pre-intervention, after 10 weeks (following completion of the intervention), after 22 weeks, and after 62 weeks.",{"measure":19,"description":20,"timeFrame":17},"Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS)","Six item scale that ask about health related quality of life in six dimensions: \"Physical condition, \"Cognition\", \"Emotions\", \"Ability to carry out daily activities\", \"Personal and social life\" and \"Current situation and future prospects\"",{"measure":22,"description":23,"timeFrame":17},"Short Form 36 (SF-36)","The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).",{"measure":25,"description":26,"timeFrame":17},"Rivermead Post-Concussion Symptoms Questionnaire (RPQ)","Score of 0-64, with a higher score indicates worse symptoms.",{"measure":28,"description":29,"timeFrame":17},"Insomnia Severity Index (ISI)","Score of 0-28, where higher scores indicate severity of insomnia.",{"measure":31,"description":32,"timeFrame":17},"Generalized Anxiety Disorder 7-Item Scale (GAD-7)","Score of 0-15, where higher scores indicate severity of anxiety experienced.",{"measure":34,"description":35,"timeFrame":17},"Patient Health Questionnaire-9 (PHQ-9)","Score of 0-27, where higher scores indicate severity of depression experienced.",{"measure":37,"description":38,"timeFrame":17},"Patient Health Questionnaire-15 (PHQ-15)","Score of 0-30, where higher scores indicate severity and burden of common physical symptoms.",{"measure":40,"description":41,"timeFrame":17},"Fear Avoidance Behavior after Traumatic Brain Injury Questionnaire (FAB-TBI)","Score of 0-48, where higher score indicates higher avoidance.",{"measure":43,"description":44,"timeFrame":17},"Behavioral Responses to Illness Questionnaire (BRIQ)","Evalutates behavioral response to illness on a four factor subscale: \"All-or-Nothing Behavior\", \"Limiting Behavior\", \"Emotional Support Seeking\" and \"Practical Support Seeking\".",{"measure":46,"description":47,"timeFrame":17},"Alcohol Use Disorders Identification Test (AUDIT)","Score of 0-40, where higher score indicates greater risk of problematic alcohol use.",{"measure":49,"description":50,"timeFrame":17},"Drug Use Disorders Identification Test (DUDIT)","Score of 0-44, where higher score indicates greater risk of problematic drug use.",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":51,"whoMasked":51},"NONE","Surviving an acquired brain injury (ABI) often means having to learn to live with changes in abilities, roles, and relationships. For some, this adaptation itself becomes a barrier to continued recovery. Difficulties in understanding and managing emotions such as grief, fear and anger may affect how a person relates to their altered functional capacity, engages in rehabilitation, and resumes everyday activities and roles. Despite this, rehabilitation after ABI is primarily focused on physical and cognitive consequences, while targeted treatment options addressing emotional adjustment remain limited.\n\nThe aim of the study is to investigate whether emotion-focused group therapy can improve this aspect of recovery after ABI. The intervention is based on Emotional Awareness and Expression Therapy (EAET) and helps participants identify, process, and express emotions and needs that have emerged in response to the illness and changes in their life circumstances. The effects of the treatment on emotional functioning, quality of life, activity, and participation will be assessed over time and complemented by interviews exploring participants' experiences of the treatment and of life after stroke.",[60,66],{"label":61,"type":62,"description":63,"interventionNames":64},"Arm 1","ACTIVE_COMPARATOR","Treatment as Usual",[65],"Behavioral: Treatment as Usual (TAU)",{"label":67,"type":68,"description":69,"interventionNames":70},"Arm 2","EXPERIMENTAL","Treatment as Usual + Group Therapy (EAET)",[71],"Behavioral: TAU + Group Therapy (EAET)",[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":51},"BEHAVIORAL","TAU + Group Therapy (EAET)","Behavioral: Treatment as usual • Individually tailored multidisciplinary rehabilitation based on an assessment of each participant's rehabilitation needs. An individual rehabilitation plan is developed, and interventions are provided by relevant members of the rehabilitation team according to the participant's identified needs. Rehabilitation may include medical management, occupational therapy, physiotherapy, psychological treatment, and psychosocial support.\n\nBehavioral: Group-based Emotional and Expression Therapy (EAET)\n\n• 10-session manualized group-based Emotional Awareness and Expression Therapy (EAET) designed to help participants identify, process, and express emotions and needs. Weekly group sessions are complemented by structured homework assignments. A follow-up session is provided three months after completion of the intervention. The intervention is delivered by a clinical psychologist.",[67],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":51},"Treatment as Usual (TAU)","Individually tailored multidisciplinary rehabilitation based on an assessment of each participant's rehabilitation needs. An individual rehabilitation plan is developed, and interventions are provided by relevant members of the rehabilitation team according to the participant's identified needs. Rehabilitation may include medical management, occupational therapy, physiotherapy, psychological treatment, and psychosocial support.",[61],[83,86],{"name":84,"affiliation":5,"role":85},"Anna Nordström, M.D.","STUDY_CHAIR",{"name":87,"affiliation":5,"role":85},"Peter Nordström, Professor",[89],{"name":90,"role":91,"phone":92,"phoneExt":51,"email":93},"Jakob Nissen, Licensed Clinical Psychologist","CONTACT","0046 18 611 24 85","jakob.nissen@akademiska.se",[95],{"facility":96,"status":97,"city":98,"state":51,"zip":51,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Uppsala University Hospital","RECRUITING","Uppsala","Sweden","SE",{"type":102,"coordinates":103},"Point",[104,105],17.63889,59.85882,{"lat":105,"lon":104},[108],{"name":90,"role":91,"phone":92,"phoneExt":51,"email":93},{"type":110,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[112],{"name":113,"class":114},"Region Uppsala Public Health and Care","OTHER_GOV","100658501","group-based-emotional-awareness-and-expression-therapy-to-support-recovery-after-acquired-brain-injury-a-clinical-development-and-evaluation-study-100658501",false,"NCT07852936","Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury: A Clinical Development and Evaluation Study","Inclusion Criteria:\n\n* Person of working age, primarily 18-65 years.\n* Acquired brain injury.\n* At least three months since the time of injury.\n* Signs of significant psychological distress, such as mental health difficulties, vulnerability to mental health problems, or dysfunctional coping.\n* Sufficient cognitive functioning and proficiency in Swedish to participate in group-based talk therapy.\n\nExclusion Criteria:\n\n* Current severe mental illness (e.g., psychosis or severe personality disorder).\n* Active substance use disorder.\n* Severe cognitive impairment that precludes participation in group-based talk therapy.\n* Other medical conditions that, based on clinical assessment, may make participation inappropriate.","ALL","18 Years",{"count":124,"type":125},110,"ESTIMATED","INTERVENTIONAL",[128],"NA","Difficulties in understanding and managing emotions may hinder recovery, rehabilitation, and participation in everyday life after acquired brain injury (ABI). Yet interventions targeting emotional adjustment after ABI remain limited.\n\nThe aim of the study is to investigate whether emotion-focused group therapy, based on Emotional Awareness and Expression Therapy (EAET), can support recovery after ABI. The intervention helps participants identify, process, and express emotions and needs related to their illness and changed life circumstances. Effects on emotional functioning, quality of life, activity, and participation will be assessed over time, alongside interviews exploring participants' experiences.",[131,132,133,134,135,136,137],"Aquired Brain Injury","Stroke","MTBI - Mild Traumatic Brain Injury","mTBI","Encephalitis","Meningitis","Hypoxia Ischemia, Cerebral",[139,140,141,142],"EAET","Emotional Awareness and Expression Therapy","Psychotherapy","Psychodynamic Psychotherapy","2026-09-25",{"date":145,"type":146},"2026-10-01","ACTUAL",{"date":148,"type":146},"2026-09-15",{"date":150,"type":125},"2031-06",{"name":5,"class":6},1]