Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Social adjustment scale
研究概览
简要总结
Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of Parkinson's disease (PD). However, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. The caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. In the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.
详细描述
After inclusion, patients (and their caregivers) are randomized into two groups stratified on their preoperative social adjustment scale couple domain score : usual treatment and psychoeducational programme or usual treatment alone (Figure). The psychoeducational programme focuses on 3 domains: 1) neurosurgical procedure and neurological outcome, 2) social life including work, social and familial relationship, 3) couple relationship. The programme consists of 7 sessions with 3 to 4 couples at the same session, except for the 'couple relationship' domain. Each domain is tackled in a two-way manner with information/education proved by the investigator and discussion of the patients' and caregivers' expectations during one session. The following session started with a 'Questions and Answers' on the previous domain and then information on another domain. Four sessions were carried out prior to surgery and 3 after.
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 (Outcomes Assessor)
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
- •Parkison's disease
- •Patients candidate for STN DBS
- •Caregiver agreeing to participate
- •Signed informed consent
排除标准
- •Contra-indication to STN-DBS
- •No caregiver agreeing to participate
- •Severe ongoing psychiatric disorder
研究组 & 干预措施
Psychoeducational programme
Psychoeducational programme
干预措施: Psychoeducational programme (Behavioral)
Usual care
No psychoeducational programme
结局指标
主要结局
Social adjustment scale
时间窗: Change from baseline at 1 year after surgery
次要结局
- Mattis dementia rating scale(Change from baseline at 1 and 2 years after surgery)
- Social adjustment scale(Change from baseline at 2 years after surgery)
- Parkinson's disease Questionnaire PDQ-39(Change from baseline at 1 and 2 years after surgery)
- Anxiety scale (STAI)(Change from baseline at 1 and 2 years after surgery)
- Parkinsonian disability (Unified Parkinson's Disease Rating Scale)(Change from baseline at 1 and 2 years after surgery)
- Dopaminergic treatment dosage (mg/day)(Change from baseline at 1 and 2 years after surgery)
研究者
Marie-laure Welter
Medical Doctor
Groupe Hospitalier Pitie-Salpetriere