NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of clinically significant depressive symptoms
研究概览
简要总结
This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.
详细描述
The objectives of the trial are:
- To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months.
- To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months.
- To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination.
- To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (≥18 years of age);
- •diagnosed with epilepsy for at least one year;
- •fluent in English or Spanish;
- •elevated depressive symptoms (PHQ-9 score ≥10);
- •willing to participate in audiotaped group telephone sessions
排除标准
- •severe depressive symptoms (PHQ-9 ≥20);
- •active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening);
- •active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR);
- •significant cognitive impairment (indicated in EHR or evident during screening)
研究组 & 干预措施
Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
UPLIFT is a telephone-based depression self-management program for people with epilepsy.
干预措施: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) (Behavioral)
Arm 2: BOOST (Bringing Out Our Strength Together)
BOOST is a telephone-based support program for people with epilepsy.
干预措施: BOOST (Bringing Out Our Strength Together) (Behavioral)
结局指标
主要结局
Presence of clinically significant depressive symptoms
时间窗: 12 month visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of \<5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of \<5 indicates absence of clinically significant depressive symptoms.
Presence of clinically significant depressive symptoms
时间窗: Baseline Visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of \<5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of \<5 indicates absence of clinically significant depressive symptoms.
Presence of clinically significant depressive symptoms
时间窗: 3 month visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of \<5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of \<5 indicates absence of clinically significant depressive symptoms.
Presence of clinically significant depressive symptoms
时间窗: 6 month visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of \<5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of \<5 indicates absence of clinically significant depressive symptoms.
次要结局
- Change in seizure frequency(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in depressive symptom severity(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in seizure severity(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in general health-related quality of life(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)
- Change in disease-specific quality of life(Baseline Visit, 3 month visit, 6 month visit, 12 month visit)