Psychoeducational Programme for PD Patients With STN-DBS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Psychoeducational programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducational programme<br>Psychoeducational programme | Behavioral: Psychoeducational programme<br>* 4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation<br>|
| No Intervention: Usual care<br>No psychoeducational programme | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social adjustment scale |  | Change from baseline at 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's disease Questionnaire PDQ-39 | Quality of life | Change from baseline at 1 and 2 years after surgery | 
| Anxiety scale (STAI) | STAI | Change from baseline at 1 and 2 years after surgery | 
| Mattis dementia rating scale | mattis dementia rating scale | Change from baseline at 1 and 2 years after surgery | 
| Parkinsonian disability (Unified Parkinson's Disease Rating Scale) | Unified Parkinson's Disease Rating Scale | Change from baseline at 1 and 2 years after surgery | 
| Dopaminergic treatment dosage (mg/day) | Daily dosage of dopaminergic agents | Change from baseline at 1 and 2 years after surgery | 
| Social adjustment scale |  | Change from baseline at 2 years after surgery |