Psychoeducational Programme for PD Patients With STN-DBS

NCT ID: NCT02554370

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2015-06-30

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Psychoeducational programme

Psychoeducational programme

Group Type: EXPERIMENTAL

Psychoeducational programme

Intervention Type: BEHAVIORAL

4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation

Usual care

No psychoeducational programme

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducational programme

4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: lead

Responsible Party

Marie-laure Welter

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yannick Vacher

Role: STUDY_CHAIR

APHP

Locations

Centre d'Investigation Clinique GHPS

Paris, Paris, France

Countries

France

Other Identifiers

2006-A00230-51

Identifier Type: -

Identifier Source: org_study_id