Psychoeducational Programme for PD Patients With STN-DBS (PSYCHE)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychoeducational programme
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease
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
Sites / Locations
- Centre d'Investigation Clinique GHPS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychoeducational programme
Usual care
Arm Description
Psychoeducational programme
No psychoeducational programme
Outcomes
Primary Outcome Measures
Social adjustment scale
Secondary Outcome Measures
Parkinson's disease Questionnaire PDQ-39
Quality of life
Anxiety scale (STAI)
STAI
Mattis dementia rating scale
mattis dementia rating scale
Parkinsonian disability (Unified Parkinson's Disease Rating Scale)
Unified Parkinson's Disease Rating Scale
Dopaminergic treatment dosage (mg/day)
Daily dosage of dopaminergic agents
Social adjustment scale
Full Information
NCT ID
NCT02554370
First Posted
September 15, 2015
Last Updated
September 17, 2015
Sponsor
Groupe Hospitalier Pitie-Salpetriere
1. Study Identification
Unique Protocol Identification Number
NCT02554370
Brief Title
Psychoeducational Programme for PD Patients With STN-DBS
Acronym
PSYCHE
Official Title
Psychoeducational Programme for Patients With Parkinson's Disease Undergoing Subthalamic Deep Brain Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Pitie-Salpetriere
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducational programme
Arm Type
Experimental
Arm Description
Psychoeducational programme
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No psychoeducational programme
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational programme
Intervention Description
4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation
Primary Outcome Measure Information:
Title
Social adjustment scale
Time Frame
Change from baseline at 1 year after surgery
Secondary Outcome Measure Information:
Title
Parkinson's disease Questionnaire PDQ-39
Description
Quality of life
Time Frame
Change from baseline at 1 and 2 years after surgery
Title
Anxiety scale (STAI)
Description
STAI
Time Frame
Change from baseline at 1 and 2 years after surgery
Title
Mattis dementia rating scale
Description
mattis dementia rating scale
Time Frame
Change from baseline at 1 and 2 years after surgery
Title
Parkinsonian disability (Unified Parkinson's Disease Rating Scale)
Description
Unified Parkinson's Disease Rating Scale
Time Frame
Change from baseline at 1 and 2 years after surgery
Title
Dopaminergic treatment dosage (mg/day)
Description
Daily dosage of dopaminergic agents
Time Frame
Change from baseline at 1 and 2 years after surgery
Title
Social adjustment scale
Time Frame
Change from baseline at 2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Vacher
Organizational Affiliation
APHP
Official's Role
Study Chair
Facility Information:
Facility Name
Centre d'Investigation Clinique GHPS
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Psychoeducational Programme for PD Patients With STN-DBS
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