Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-30 @ 10:57 PM
Study NCT ID:
NCT04126369
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIMEDIT
Brief Summary:
This study evaluates a mindfulness intervention in patients with drug resistant epilepsy.
Half of participants will follow a mindfulness programme, while the other half will follow a self management programme.
Half of participants will follow a mindfulness programme, while the other half will follow a self management programme.
Detailed Description:
Drug-resistant epilepsy is associated with an alteration of the quality of life mainly related to psychiatric comorbidities (anxiety and depression). The management of these comorbidities is therefore essential in patients with drug resistant epilepsy, Ideally through non-drug management to minimize the side effects of molecules.
The goal of mindfulness interventions in pathology is to learn to better live with a chronic disease by reducing the stress resulting from the disease, by increasing benevolence towards oneself, the acceptance of the disease and reducing the ruminations linked with the pathology.
Mindfulness therefore seems to be a good way for these patients to improve the management of their emotions and thus improve their quality of life what the investigators propose to evaluate in this study.
The study consists of two phases
1. First phase: comparative randomized study (primary endpoint):
1. After inclusion, a 2 months baseline follow-up is carry to collect the judgement criteria without intervention.
2. At the end of this period, patients will be randomly assigned to the mindfulness intervention group or the control group with the psycho educative programme. Both programmes will takes 3 months.
3. Then a 6-months post-intervention follow-up period for both groups
Patients will have assessment visits every 3 months. They will also complete a daily notebook including the number of seizures they have done and a scale of their "interior weather".
2. Second phase (optional):
At the end of the first phase, patients in the control group will be able to benefit from the mindfulness programme and will be followed at the end of the programme for 6 months.
The goal of mindfulness interventions in pathology is to learn to better live with a chronic disease by reducing the stress resulting from the disease, by increasing benevolence towards oneself, the acceptance of the disease and reducing the ruminations linked with the pathology.
Mindfulness therefore seems to be a good way for these patients to improve the management of their emotions and thus improve their quality of life what the investigators propose to evaluate in this study.
The study consists of two phases
1. First phase: comparative randomized study (primary endpoint):
1. After inclusion, a 2 months baseline follow-up is carry to collect the judgement criteria without intervention.
2. At the end of this period, patients will be randomly assigned to the mindfulness intervention group or the control group with the psycho educative programme. Both programmes will takes 3 months.
3. Then a 6-months post-intervention follow-up period for both groups
Patients will have assessment visits every 3 months. They will also complete a daily notebook including the number of seizures they have done and a scale of their "interior weather".
2. Second phase (optional):
At the end of the first phase, patients in the control group will be able to benefit from the mindfulness programme and will be followed at the end of the programme for 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: