Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change (from baseline) in HADS
研究概览
简要总结
The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's Disease
- •At least mild to moderate depression or anxiety defined as HADS-A or HADS-D > 7
排除标准
- •Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview
- •Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)
- •Difficulties that hamper the use of a computer
- •The patient states difficulties in finding enough time for treatment
- •Too low cognitive functioning defined as MoCA < 24
- •Too severe depression, defined as MADRS-S over 30
- •Too high suicidal risk defined as more than 4 points on the MADRS-S question 9 or according to the structured assessment interview
结局指标
主要结局
Change (from baseline) in HADS
时间窗: 12 weeks (Post), 3 and 6 months (FU)
Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression
次要结局
- Change (from baseline) in MADRS-S(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in ISI(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in PDQ-8(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in NMSQuest(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in EQ-5D(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in SDS(12 weeks (Post), 3 and 6 months (FU))
研究者
Viktor Kaldo
Principal Investigator
Karolinska Institutet