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Psychoeducational Programme for PD Patients With STN-DBS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02554370
Acronym
PSYCHE
Enrollment
19
Registered
2015-09-18
Start date
2008-02-29
Completion date
2015-06-30
Last updated
2015-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

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

Sponsors

Groupe Hospitalier Pitie-Salpetriere
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Social adjustment scaleChange from baseline at 1 year after surgery

Secondary

MeasureTime frameDescription
Anxiety scale (STAI)Change from baseline at 1 and 2 years after surgerySTAI
Mattis dementia rating scaleChange from baseline at 1 and 2 years after surgerymattis dementia rating scale
Parkinson's disease Questionnaire PDQ-39Change from baseline at 1 and 2 years after surgeryQuality of life
Dopaminergic treatment dosage (mg/day)Change from baseline at 1 and 2 years after surgeryDaily dosage of dopaminergic agents
Social adjustment scaleChange from baseline at 2 years after surgery
Parkinsonian disability (Unified Parkinson's Disease Rating Scale)Change from baseline at 1 and 2 years after surgeryUnified Parkinson's Disease Rating Scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026