PEARL Intervention to Reduce Depression Among Adults With Epilepsy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean SCL-20 depression scores
研究概览
简要总结
The purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "Program to Encourage Active, Rewarding Lives (PEARL)". We hypothesize that over a 12-month period, compared to usual care, those receiving the PEARL intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.
详细描述
Compared to non-depressed individuals with epilepsy, those with depression have significantly higher rates of suicide, lower social and occupational functioning, decreased quality of life independent of seizure frequency, and higher non-psychiatric health care utilization. Adults with epilepsy are more likely to be homebound as a result of reduced function and restrictions in driving, opportunities to obtain enhanced quality of care for depression may be limited. This study tests the effectiveness of a home-based multi-modal depression treatment intervention called Program to Encourage Active, Rewarding Lives (PEARL). PEARL consists of problem solving treatment, social and physical activation, pleasant events scheduling, support and education regarding antidepressant medication use as well as psychiatric consultation and recommendations regarding initiation or adjustment of antidepressant medications.
In a sample of adults with epilepsy who have minor depression, major depression and/or dysthymia, we hypothesize that over a 12-month period, compared to usual care, those randomized to the PEARL intervention will: achieve higher levels of depression response and remission, achieve higher quality of life and function, and utilize less non-psychiatric health care.
By providing a multi-modal, home-based stepped collaborative care intervention for adults with depression and epilepsy, this program will offer practical alternatives to usual care and will provide a program for improving depression outcomes, quality of life and potentially, epilepsy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Home address within 30 miles of Seattle
- •Diagnosis of epilepsy (ICD-9 code 345.XX)
- •Appointment in the UW REC or Neurology clinic in the past 2 years and currently enrolled in this clinic.
- •Current age older than 18 years
- •Diagnosis of major depression, minor depression or dysthymia
- •Ability to speak/read English
排除标准
- •Alcohol and/or substance abuse/dependence based on a score greater than 1 on 4-item validated CAGE-AID
- •Cognitive impairment based on a score less than 3 on a 6-item validated cognitive screen
- •Diagnosis of bipolar disorder, schizophrenia/schizoaffective disorder or other psychotic disorder
- •Women who are pregnant or nursing
- •Terminal medical illness
- •Those currently seeing or planning to see a psychiatrist
- •Those with suicidal ideation nearly every day
结局指标
主要结局
Mean SCL-20 depression scores
时间窗: 6 & 12 months post-baseline
Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline
时间窗: 6 & 12 months post-baseline
Complete depression remission defined as SCL-20 score less than 0.5.
时间窗: 6 & 12 months post-baseline
次要结局
- Satisfaction with epilepsy health care(6 & 12 months post-baseline)
- Quality of Life(6 & 12 months post-baseline)
- Pharmaceutical and health care utilization and costs(6 & 12 months post-baseline)
- Seizure frequency and severity(6 & 12 months post-baseline)
- Epilepsy Self-Efficacy(6 & 12 months post-baseline)