Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Enrollment rate
研究概览
简要总结
The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking veterans
- •has home internet access
- •has access to and familiarity in using a computer or tablet at least weekly
- •Asymptomatic patients with chronic conditions
- •has access to a mobile device with Short Message Service (SMS) text and picture capability
- •has an active clinical diagnosis of major depressive disorder based on the International Classification of Diseases, 10th version (ICD-10)
- •has an ICD-10 diagnosis of epilepsy with at least one seizure documented within the last five years
排除标准
- •pregnancy
- •Veterans that have current suicidal ideation
- •have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.
研究组 & 干预措施
Neurobehavioral therapy
干预措施: Neurobehavioral therapy (Behavioral)
结局指标
主要结局
Enrollment rate
时间窗: post intervention (14 weeks after baseline)
This is defined as the number enrolled divided by the number of eligible participants screened
Retention rate
时间窗: post intervention (14 weeks after baseline)
This is defined as the number completing the study/number enrolled at baseline
Session attendance rate (proportion of sessions attended)
时间窗: post intervention (14 weeks after baseline)
Homework completion rate (proportion of homework assignments completed)
时间窗: post intervention (14 weeks after baseline)
User satisfaction as assessed by The Participant Satisfaction Survey
时间窗: post intervention (14 weeks after baseline)
This is a 16 item questionnaire and the first 10 questions are scored from 1( strongly disagree)to 5(strongly agree) for a maximum score of 50, higher score indicating better outcome
次要结局
- Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),(baseline, end of session 12 (12 weeks form baseline))
- Change in quality of Life as assessed by the Quality of Life in Epilepsy Inventory-10 (QOLIE-10)(baseline, end of session 12(12 weeks form baseline))
- Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)(baseline, end of session 12(12 weeks form baseline))
- Change in efficacy in the self management of epilepsy as assessed by the Epilepsy Self-Efficacy Scale (ESES)(baseline, end of session 12(12 weeks form baseline))
研究者
Melissa Fadipe
Student
The University of Texas Health Science Center, Houston