Impact of Mindfulness Intervention on Quality of Life in Patients With

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04126369
Study type	Interventional
Source	University Hospital, Grenoble
Contact	Cécile SABOURDY, MD
Phone	04767656.9
Email	CSabourdy@chu-grenoble.fr
Status	Recruiting
Phase	N/A
Start date	January 20, 2020
Completion date	September 20, 2027

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms