NCT02554370

Psychoeducational Programme for PD Patients With STN-DBS

Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
BEHAVIORAL	Psychoeducational programme	4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-09-01
• Completion: 2015-06-01
• First posted: 2015-09-18
• Last updated: 2015-09-18

Locations

1 site across 1 country: France