Preventing Depression in People With Epilepsy: an Extension of Project UPLIFT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 8
- 主要终点
- Changes in Depressive Symptoms
研究概览
简要总结
Project UPLIFT, a home-based treatment for depression in people with epilepsy, was designed to be delivered to groups by telephone or Web. The Project UPLIFT intervention materials were demonstrated to be effective in treating depression among people with epilepsy in Georgia. This project will assess whether the materials are also effective for preventing depression among people with epilepsy, and will extend the project beyond Georgia to Michigan, Texas, and Washington.
详细描述
The study is a pilot test of Project UPLIFT for depression prevention during which the acceptability and estimates of effectiveness of the intervention, presented in the Web and telephone modes, are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of epilepsy
- •at least three months post initial diagnosis of epilepsy and either on medication or permission of the physician
- •symptoms of depression, but absence of moderate-to-severe depression, (8 < CES-D < 27)
- •21 years of age and older
- •English speaking
- •had access to a telephone
- •mentally stable, as determined by a score of > 26 on the Telephone Mini-Mental Status Exam (T-MMSE)
- •willing to participate
- •willing to complete assessments three times
排除标准
- •no diagnosis of epilepsy
- •less than 3 months since diagnosis of epilepsy
- •no depressive symptom (CES-D <8)
- •severe depression (CES-D > 27)
- •suicidal ideation
- •previous participation in Project UPLIFT
结局指标
主要结局
Changes in Depressive Symptoms
时间窗: Baseline (at 0 week) , Interim (at 8 weeks), Follow-up (at16 weeks)
Changes in depressive symptoms are measured using the modified Beck Depression Inventory (mBDI).
次要结局
- Changes in seizure severity(Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
- Changes in Depression and Mindfulness Knowledge and Skills(Baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
- Change in Seizure Activity(Baseline (0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
- Changes in Depressive Symptoms(baseline (at 0 week), Interim (at 8 weeks), Follow-up (at 16 weeks))
研究者
Nancy J Thompson, PhD
Associate Professor, Behavioral Sciences and Health Education
Emory University