Collaborative Care to Improve Quality of Life for Anxiety and Depression in Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
研究概览
简要总结
This is a randomized effectiveness/implementation trial comparing a 24-week neurology-based collaborative care intervention to usual neurology care among 60 adults with epilepsy.
详细描述
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/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The randomization table will be prepared by the study statistician, uploaded by the developer, and concealed from the PI and coordinators in the REDCap data management system until after consent, enrollment and baseline data collection is complete, to minimize bias - once participants are randomized it is just outcome assessor who is truly blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •For the third Aim (sustainability supplement: intervention only care delivery exploratory study supplement) - the Participants meeting the following criteria may participate
- •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
- •individuals who meet the above INC-EXC criteria and receive clinical neurological care at Atrium Health Wake Forest Baptist
研究组 & 干预措施
usual neurology care
Ongoing usual neurology care, without the addition of the collaborative care program - current standard care and is thus an ethically appropriate control condition for effectiveness and implementation trials.
干预措施: usual neurology care (Behavioral)
collaborative care
The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.
干预措施: collaborative care (Behavioral)
结局指标
主要结局
change in emotional quality of life subscale of the Quality of Life in Epilepsy Inventory (QOLIE-31) - between two groups
时间窗: Month 6
adults with epilepsy and anxiety or depression symptoms - a higher score reflects a more favorable health state
次要结局
- Change in Epilepsy-specific quality of life scoring (QOLIE-31) - neurology collaborative care compared to Usual Care(Month 6)
- Number of Participants adhering to Intervention(Week 12)
- Change in anxiety symptoms scoring (EASI) Epilepsy Anxiety Survey Instrument - between groups(Month 6)
- Change in the number of depression symptoms - Beck's Depression Inventory (BDI-II) - neurology collaborative care compared to Usual Care(Month 6)