Clinical trial NCT02554370: Psychoeducational Programme for PD Patients With STN-DBS
Official title: Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Parkison's disease
* Patients candidate for STN DBS
* Caregiver agreeing to participate
* Signed informed consent

Exclusion Criteria:

* Contra-indication to STN-DBS
* No caregiver agreeing to participate
* Dementia
* Severe ongoing psychiatric disorder

Primary outcomes:
measure: Social adjustment scale
timeFrame: Change from baseline at 1 year after surgery
Secondary outcomes:
measure: Parkinson's disease Questionnaire PDQ-39
timeFrame: Change from baseline at 1 and 2 years after surgery
measure: Anxiety scale (STAI)
timeFrame: Change from baseline at 1 and 2 years after surgery
measure: Mattis dementia rating scale
timeFrame: Change from baseline at 1 and 2 years after surgery
measure: Parkinsonian disability (Unified Parkinson's Disease Rating Scale)
timeFrame: Change from baseline at 1 and 2 years after surgery
measure: Dopaminergic treatment dosage (mg/day)
timeFrame: Change from baseline at 1 and 2 years after surgery
measure: Social adjustment scale
timeFrame: Change from baseline at 2 years after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique GHPS
Study officials:
affiliation: APHP
name: Yannick Vacher
role: STUDY_CHAIR
References: