A Pilot Study for Managing Depressive Symptoms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Actual use of intervention
研究概览
简要总结
The purpose of this research is to evaluate the feasibility and effectiveness of Digital Neurotherapy (DNT) or Capacity Coaching (CC) for managing symptoms of depression and self reported pain in Autosomal Dominant Polycystic Kidney Disease (ADPKD) compared to education alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of ADPKD using Pei-Ravine criteria
- •Pre-End Stage Kidney Disease, with Stage 1-5 CKD (eGFR >10 ml/min/1.73m2, with no anticipated dialysis or transplant within 12 months)
- •Clinical or self-diagnosis of depression
- •English-language fluency
排除标准
- •Suicidal ideation/unstable mental illness of any kind
- •Lack of access/ability to use internet-based programs
- •eGFR <10 ml/min/1.73m2
- •Anticipated dialysis or transplant within 6 months
- •Prior chronic dialysis
- •Prior organ (liver or kidney) transplant
- •Lack of English language fluency
- •Significant cognitive impairment (Mini Mental Status Exam (MMSE))
研究组 & 干预措施
Mayo Clinic-Approved Education
The control group will receive standard of care, Mayo Clinic approved education for a duration of 60 minutes, every 2 weeks for 6 sessions (12 weeks)
干预措施: Mayo Clinic-Approved Education (Behavioral)
Digital Neuropathy
The Digital Neuropathy group will utilize the web-based system (REJUVENATE) for a duration of 20 minutes, 4 times per week (12 weeks)
干预措施: Digital Neuropathy (Behavioral)
Capacity Coaching
The Capacity Coaching group will participate in calls with a board certified health and wellness coach for a duration of 60 minutes, every 2 weeks, for 6 sessions (12 weeks)
干预措施: Capacity Coaching (Behavioral)
结局指标
主要结局
Actual use of intervention
时间窗: 12 weeks
Actual use of each intervention will be reported as the percentage of eligible subjects participating in the assigned interventions at least twice a week for at least 20 minutes per session.
次要结局
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS-S) score(Baseline, 12 weeks)