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

NCT04126369 | Recruiting

• 1 other identifier: 38RC18.209
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Drug Resistant Epilepsy

Keywords

Drug Resistant Epilepsy; mindfulness; self management

Outcome Measures

Primary Outcomes (1)

• Evolution of Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) score.

  The QOLIE31-P questionnaire has been developed specifically to measure the quality of life of patients with epilepsy. The score ranges from 0 to 100 points. Higher scores reflect better quality of life; lower ones, worse quality of life. The score of QOLIE31-P will be assess prior to intervention and then at month 3, month 6 and month 9 after the beginning of the intervention. Ref : Cramer JA. Van Hammee G. N132 Study Group. Maintenance of improvement in health-related quality of life during long-term treatment with levetiracetam. Epilepsy \& Behavior 2003; 4:118-123.

  9 months

Secondary Outcomes (9)

• Evolution of seizures frequency

  9 months

• Evolution of psychiatric morbidity

  9 months

• Evolution of anxiety level

  9 months

• Evolution of stress management

  9 months

• Evolution of stress level

  9 months

Study Arms (2)

mindfulness intervention

EXPERIMENTAL

12 mindfulness sessions for 3 months (1 session per week)

Other: mindfulness intervention

Psycho educative programme

ACTIVE COMPARATOR

12 psycho educative sessions for 3 months (1 session per week)

Other: psycho educative programme

Interventions

mindfulness intervention OTHER

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.

mindfulness intervention

psycho educative programme OTHER

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.

Psycho educative programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Drug resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE)
• Stable therapy for at least 3 months
• No planned surgery
• Patient affiliated to social security insurance or beneficiary of social security insurance.
• Signed consent

You may not qualify if:

• Patient who has previously had or regularly practicing mindfulness
• Patient with psychogenic non-epileptic seizures
• Pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to legal protection
• Patient with relationship disorders related to psychosis
• Patients who are unable or unwilling to work as a group or person unable to understand the topics discussed during session.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (3)

Epileptology Department of The Grenoble University Hospital

Grenoble, France

RECRUITING

Epileptology Department of the Lyon University Hospital

Lyon, France

NOT YET RECRUITING

La Teppe medical centre

Tain-l'Hermitage, France

NOT YET RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Cécile SABOURDY, MD

CONTACT

04767656.9; CSabourdy@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: October 15, 2019
• Study Start: January 20, 2020
• Primary Completion: January 20, 2026
• Study Completion (Estimated): September 20, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)