NCT04126369

Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
OTHER	mindfulness intervention	The mindfulness program is conducted in a group session of up to 10 people. Each session lasts 2 hours. A total of 12 sessions will be conducted by a practitioner who is specifically trained in this type of programme.
OTHER	psycho educative programme	The psycho-educational control intervention will follow the same format and structure as the mindfulness meditation intervention in terms of group format, session duration and frequency. This is a therapeutic education programme developed for several years in the neurology department of the university hospital of Lyon and Grenoble. The program follows the repository recommended by the french league against epilepsy.

Timeline

• Start date: 2020-01-20
• Primary completion: 2026-01-20
• Completion: 2027-09-20
• First posted: 2019-10-15
• Last updated: 2024-05-08

Locations

3 sites across 1 country: France