Psychological and Psychiatric Assessment in Patients Eligible for Epilepsy Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About this trial
The aim of the study is to describe the socio-demographic, clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes in these parameters over time after surgery. Additionally, the study seeks to describe the levels of quality of life, dissociative experiences, prevalence of various psychiatric symptoms, irritability, depressive symptoms, anxiety symptoms, and stigma perception in patients with drug-resistant focal epilepsy eligible for epilepsy surgery and any changes over time after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 or older at the time of enrollment;
Patients with drug-resistant focal epilepsy followed at the Institute for at least 6 months;
Patients with drug-resistant focal epilepsy eligible for epilepsy surgery;
Patients capable of providing informed consent to participate in the study and for the processing of personal data.
Disqualifiers
Patients with evident and/or diagnosed cognitive or psychiatric disorders that prevent participation in an interview, proper understanding of informed consent, or completion of questionnaires.
Trial design
Design model
Single group
Treatments tested in this trial
quality of life
Diagnostic testThe following assessment tools will be proposed to patients: * Quality of Life in Epilepsy (QOLIE-31)26 * Dissociative Experience Scale (DES)27 * Symptom Checklist-90 (SCL-90)28 * Irritability Questionnaire (I-EPI)29 * Beck Depression Inventory II (BDI-II)30 * State-Trait Anxiety Inventory Y-1 e Y-2 (STAI)31 * Epilepsy Stigma Scale modificata32 These assessment tools are validated and used universally, and will allow the collection of information on the psychological and psychiatric functioning of the patients.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: patients with drug-resistant focal epilepsyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Psychological characteristics
Description of the time course of the clinical, psychological, and psychiatric characteristics of patients with drug-resistant focal epilepsy eligible for epilepsy surgery
Time frame
6 yearsSecondary outcomes
1
Levels of quality of life
Description of the time course of the levels of quality of life, dissociative experiences, prevalence of various psychiatric symptoms, levels of irritability, depressive symptoms, anxiety symptoms, and stigma perception in patients with drug-resistant focal epilepsy eligible for immediate epilepsy surgery.
Time frame
6 yearsSponsors and contacts
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Source ClinicalTrials.gov