[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05559749":3,"trial-entities:NCT05559749":108,"trial-summary:NCT05559749":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":47,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":89,"locations":92,"central_contacts":101,"overall_officials":102,"references":106,"see_also_links":107},"NCT05559749","IRB00088764","Collaborative Care for Anxiety and Depression in Epilepsy","Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy","ACTIVE_NOT_RECRUITING","2027-03","2026-01","2026-08-26","2023-05-04","Wake Forest University Health Sciences","OTHER",true,"This is a randomized effectiveness\u002Fimplementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.","The intervention is a 24-week, evidence-based collaborative care model initiated around the time of a neurology visit. The collaborative care team roles include the care manager\u002Fsocial worker and psychiatrist who interact with the patient participant and the patient's neurologist\u002Fneurology provider.",[19,20,21],"Epilepsy","Anxiety","Depression",[23,24],"Quality of Life","Collaborative care","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},60,"ESTIMATED",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","collaborative care","a 24-week neurology based collaborative care program consisting of: 1. a series of every 2 weeks care management calls by the care manager to evaluate anxiety, depression, seizures and side effects and deliver brief therapy interventions to the participant, and 2. collaborative care conferences including a psychiatrist to generate expert recommendations for anxiety and depression management and communication of recommendations between the care manger, psychiatrist and neurologist.",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"usual neurology care","ongoing usual neurology care, without the addition of the collaborative care program",[39],[43],{"measure":44,"description":45,"timeFrame":46},"change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups","adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state","Month 6",[48,52,55,58],{"measure":49,"description":50,"timeFrame":51},"Number of Participants adhering to Intervention","adherence of intervention participants to the majority of care management - proportion of intervention group participants meeting minimum adherence metric of 50% call participation at 12 weeks","Week 12",{"measure":53,"description":54,"timeFrame":46},"Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care","adults with epilepsy and anxiety or depression symptoms - Score ranges from 0-100 with higher score indicating better epilepsy-specific quality of life",{"measure":56,"description":57,"timeFrame":46},"Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care","adults with epilepsy and anxiety or depression symptoms -- Depression symptom questionnaire-score ranges from 0-61, with higher score indicating more severe depression symptoms",{"measure":59,"description":60,"timeFrame":46},"Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups","adults with epilepsy and anxiety or depression symptoms - The score was obtained by computing the sum of the scores obtained by items associated with it, from 0, \"not at all\", to 3, \"nearly every day\". The possible total score ranges from 0 to 54, with higher scores indicating worse anxiety symptoms","ALL","18 Years",null,false,{"inclusion":66,"exclusion":73,"raw_text":88},[67,68,69,70,71,72],"Provision of signed and dated Informed Consent Form","Stated willingness to comply with all study procedures","Males and Females; Age \\>= 18 years","\\* Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings","Anxiety or Depression symptoms","Receiving clinical neurological care at Atrium Health",[74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Current participation in another treatment of intervention study","Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview","Comorbid medical condition with life expectancy less than 6 months","Not a good candidate for collaborative care due to:","Active ongoing treatment by a psychiatrist","Active suicidal ideation","History of past suicide attempt and:","receiving ongoing psychotherapy OR","has seen a psychiatrist in the past year","History of suicide attempt in the past year and:","currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators","Unstable drug or alcohol abuse","individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or","individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures","Inclusion Criteria:\n\n* Provision of signed and dated Informed Consent Form\n* Stated willingness to comply with all study procedures\n* Males and Females; Age \\>= 18 years\n* \\* Diagnosis of epilepsy: Epilepsy diagnosis based on neurology clinician impression or EEG findings\n* Anxiety or Depression symptoms\n* Receiving clinical neurological care at Atrium Health\n\nExclusion Criteria:\n\n* Current participation in another treatment of intervention study\n* Cognitive limitations precluding completion of Anxiety and Depression self-report instruments on paper, electronically, or by interview\n* Comorbid medical condition with life expectancy less than 6 months\n* Not a good candidate for collaborative care due to:\n* Active ongoing treatment by a psychiatrist\n* Active suicidal ideation\n* History of past suicide attempt and:\n* receiving ongoing psychotherapy OR\n* has seen a psychiatrist in the past year\n* History of suicide attempt in the past year and:\n* currently prescribed 2 or more psychotropic medications for psychiatric indication (not merely as a hypnotic) AND not felt to be a good candidate for collaborative care based on the judgement of the investigators\n* Unstable drug or alcohol abuse\n\nFor the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate\n\n* individuals who meet the above INC-EXC criteria and have completed the Control Arm of a collaborative care research study - NCT05559749 - NCT05353452 or\n* individuals who meet the above INC-EXC criteria except rather than having a diagnosis of Epilepsy; they have a diagnosis of functional neurological disorder with seizures",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":13,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"Winston-Salem","North Carolina","27157","United States",{"lat":99,"lon":100},36.09986,-80.24422,[],[103],{"name":104,"affiliation":13,"role":105},"Heidi M Munger Clary, MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":112},[110,111],"Functional neurological disorder","Seizure Disorder",[],{"nct_id":4,"found":15,"summary":114,"prompt_version":123},{"design":115,"status":116,"heading":6,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an interventional study comparing two approaches to care. It plans to enroll 60 adult participants.","completed","This study is looking at two ways to help adults who have epilepsy along with anxiety or depression. One group will receive \"collaborative care,\" which is a 24-week program where a care manager checks in every two weeks to discuss anxiety, depression, seizures, and side effects, and offers brief therapy. This care manager and a psychiatrist will work with your neurologist. The other group will receive \"usual neurology care,\" which is your regular care without this extra program. The study wants to see if collaborative care improves your emotional quality of life after six months. You can join if you are 18 or older, have epilepsy, and experience anxiety or depression symptoms, and receive care at Atrium Health. The study is currently unclear on its recruitment status.","Your emotional quality of life will be measured at Month 6.",127,"If you participate, you would either receive 24 weeks of collaborative care, including bi-weekly calls with a care manager, or continue with your usual neurology care.","Not stated in the trial record.",[35,39],"v2"]