Psychoeducational Programme for PD Patients With STN-DBS (PSYCHE)

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Psychoeducational programme

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Centre d'Investigation Clinique GHPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Investigators: Study Chair: Yannick Vacher, APHP

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2006-A00230-51